Psychedelics Archives - Page 2 of 26 - Green Market Report

StaffJune 15, 2022
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3min5590

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) reported its financial results for the first quarter ending April 30, 2022. Awakn recorded revenue of $253,154 via Awakn’s clinics versus zero in the prior year. This represents a 23.9% or $48,834 versus the three months ended January 31, 2022.

The company said the revenue was primarily driven by the provision of ketamine-assisted therapies at the Oslo clinic in Norway and the Bristol clinic in the UK as the flagship London clinic in the UK only began delivering treatments in April 2022

Anthony Tennyson, Chief Executive Officer of Awakn Life Sciences, said, “Today’s results demonstrate the significant momentum building in our business across both our research and development pipeline and in our therapeutics commercialization business. The addiction treatment market opportunity is, unfortunately, large and growing, and Awakn is uniquely positioned to offer proven therapeutics supported by data to sufferers for whom the current standard of care is inadequate and relapse rates are unacceptably high.”

Addiction Efforts

Awakn noted that it continues to focus on various addiction treatment options. It initiated a follow-on behavioral study investigating Ketamine as a treatment for Gambling Disorder. The study will be the first investigation globally to explore this technique to treat Gambling Disorder. It also filed a Patent Cooperation Treaty (PCT) application for the treatment of behavioral addictions with Ketamine and Ketamine-assisted psychotherapy. This followed the successful completion of Awakn’s behavioral addictions study, and the data provided from the study was used in the patent filing.

“During the quarter we achieved a number of significant milestones, including the completion of the world’s first Ketamine study for a range of behavioral addictions including Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior Disorder. We also received regulatory approval for our flagship London clinic. Q1 was another period in which we made significant progress towards our goal of bringing effective therapeutics to addiction sufferers in desperate need.”

The company has $2.8 million in cash and anticipates opening another clinic. The company also hopes to receive regulatory and ethics approval for Phase III clinical trial for Ketamine-Assisted Therapy for the treatment of Alcohol Use Disorder

 


Dave HodesJune 14, 2022
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8min7340

Editors Note: This story was originally published on June 13, but due to some technical problems we had to reset the website and as a result, the story got erased. This is the same story but republished.

 

Biotechnology is always a dicey business to create, run, and make profitable. Psychedelics add a difficulty factor of 10 to that equation.

Currently, there are many psychedelic companies still working their compound through clinical trials—with no actual product to market and sell for years.

Much of the real success of any psychedelic business hinges on the completion of clinical trials and Food and Drug Administration (FDA) approval, which takes serious time and money and is never guaranteed. 

And with any startup business, there is always risk: internal threats, external threats, workforce issues such as illness or theft, fraud, market changes, facility damage, rent increase—it’s a fairly exhaustive list.

An SBA financial education course presents a sort of Business Risks 101: Good risk management will help a business continue in operation. Mitigated risk leads to better cash flow and greater stability. Creditors will see this stability and good cash flow reflected in a company’s financial reports. Greater stability will mean the company will last into the future. 

The rewards of risk management are all linked together: good cash flow leads to stability, which leads to good credit, which leads to longevity.

Even before the startup business really gets off the ground, an investor should have done their due diligence on the risk they could be exposed to by the business, and do an analysis of an investment’s returns compared to its risk, with the expectation that a greater degree of risk is supposed to be compensated by a higher expected return.

There are computations and equations for determining risk using statistical methods that are historical predictors of investment risk and volatility, such as standard deviation, Sharpe ratio, value at risk, conditional value at risk, and others.

But all that cool analysis may or may not work in the hot, complicated world of the psychedelics industry, even with the news that nearly 50 psychedelic companies have gone public. Going public can offer a more secure investment because it helps a company raise capital to invest in future operations, expansion and acquisition.

Due diligence for a public company in the U.S. also means checking the U.S. Securities and Exchange Commission (SEC) filing of any company they are considering. 

The SEC filing can show how some psychedelics companies are still scrambling to organize their operations—even as investor money pours in seemingly oblivious to the danger at hand.

Take the sure thing as one example: Atai Life Sciences (NASDAQ: ATAI) . The company has eight lead investors, and has gone through 10 funding rounds since mid-2018, raising a total of $347.1 million. 

It’s one of the most closely watched psychedelics companies by investors. But the stock has been experiencing a steady decline since November, 2021, from just over $17/share to less than $4/share.

And company executives admitted in the company’s SEC filing that the company did not design and maintain formal accounting policies, processes and controls related to complex transactions necessary for an effective financial reporting process. “These deficiencies constitute material weaknesses in the design of our internal controls over financial reporting,” they said in their filing (pg. 60). “As a result of the material weaknesses, we have relied, in part, on the assistance of outside advisors with expertise in these matters to assist us in the preparation of our consolidated financial statements and in our compliance with SEC reporting obligations and expect to continue to do so while we remediate these material weaknesses.” 

As of March 31, 2022, those weaknesses had still not been remediated… but the company reported it had $335 million in cash as of that same day, the day of its first quarter reporting.

All that cash, all those funding rounds, and a crashing stock price.. under a management structure the company admitted had “material weaknesses.” 

Still too risky? Most investors would agree. 

But then there’s the 400 pound gorilla in the room: Predictions of a global psychedelic drugs market are very encouraging to say the least. Data Bridge Market Research says that the global market is expected to reach $6.4 billion by 2029, up from $2.4 billion in 2021.

Positive signs one day, red flags the next, all coming amidst projections of a wildly profitable industry just gaining its footing and attracting more startups. What’s the end game here?

There’s always risk in any business. But as the saying goes: Let the buyer beware.


Dave HodesJune 14, 2022
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13min10400

One of the most important benefits of psychedelics research and development is how it has employed the newest approaches of medical technology to find out exactly how and what psychedelics do inside the human body. 

Most of what psychedelic compounds research is about today are how psychedelics target the human serotonin 2A receptor used to treat neuropsychiatric diseases in the brain for such conditions as treatment-resistant depression, PTSD, and a host of other mental health conditions.

There’s still a lot to learn, and precision medicine is becoming a trusted guide in discovery and treatment.

Precision medicine is defined as an approach to medical care in which disease prevention, diagnosis, and treatment are tailored to the genes, proteins, and other substances in the human body, according to the National Cancer Institute.

Precision medicine primarily uses genetic testing to identify changes in gene sequence such as deletions, additions, or misspellings; genome sequencing to accurately diagnose diseases that are difficult to diagnose using clinical or laboratory criteria alone; and biomarkers. 

Biomarkers

Biomarkers are almost any measurement reflecting an interaction between a biological system and a potential hazard, which may be chemical, physical, or biological, including everything from pulse and blood pressure through basic chemistries to more complex laboratory tests of blood and other tissues.

Genetic testing can determine that some people have inherited conditions that make them more likely to get a disease. For example, women with a BRCA1 or BRCA2 gene mutation are more likely to get breast or ovarian cancer, and men with a BRCA1 or BRCA2 gene mutation have an increased risk for breast cancer as well (and prostate cancer).

Precision medicine has been used in pharmaceutical development since it was first investigated beginning in 2011. Researchers suggested a framework for creating an information system of disease that integrates the rapidly expanding range of information on the causes of disease and allows researchers, healthcare providers, and the public to share and update the information. 

The idea behind the framework is that, by analyzing connections between information sets (for example between the genome and environmental exposures) scientists would be able to formulate and test disease mechanisms, and clinicians could develop new treatments based on unique features of a disease and tailored to each patient. The availability of more diverse information about each disease would allow insurers and health care providers to more precisely define disease subtypes.

When it comes to psychedelics, there are unique challenges for precision medicine and the ongoing search for how they work in the human brain. Molecular imaging studies with positron emission tomography (PET) or single-photon emission computer tomography (SPECT) are being used to depict the uptake and binding distribution of certain hallucinogenic compounds in the brain. Functional magnetic resonance imaging (fMRI) is helping researchers understand how specific psychedelics such as psilocybin and LSD work in the brain.

Researchers are coming up with improved precision medicine efforts to get a comprehensive understanding of the lasting effects of psychedelic treatment. To do that, they can employ a personalized patient care approach. 

One example of a personalized care approach is discussed in a recently published paper offering an evaluation of the synergistic use of virtual reality (VR) and psychedelic-assisted psychotherapy (PAP), providing recommendations on how clinicians and research organizations can best utilize VR integrated into a robust PAP protocol. It outlines contextual VR design specifications. 

The research demonstrates that VR can simultaneously allow a further glimpse into psychological and neurological mechanisms that are at play during an altered state. 

The authors of the paper suggest that VR can be utilized for its ability to mitigate psychological side effects through enhancing the state of relaxation; encouraging entering the inner world of experience by inducing a mindful presence, and; strengthening resilience around facing challenging experiences.

More explorations into personalized precision medicine for psychedelics come from Beckley Psytech Limited, a company addressing neurological and psychiatric disorders through the novel application of psychedelic medicines, which partnered with Empatica, Inc., medical wearables and digital biomarker company offering continuous, passive monitoring for patients with neurological conditions to support the collection and analysis of behavioral and physiological data in Beckley Psytech’s future clinical trials.

The partnership allows Empatica’s EmbracePlus wearable device and associated software to identify and measure passive behavioral and physiological signals in the upcoming Phase 2 studies evaluating the use of 5-MeO-DMT (DMT) in combination with psychotherapy in the treatment of treatment-resistant depression (TRD). “The digital enhancement of the psychedelic treatment pathway aims to support patients before, during, and after treatment through the application of novel, predictive biomarkers which will potentially identify early signals of patient response and relapse,” according to a press release.

Another example is Ehave, Inc. (OTC Pink: EHVVF), a healthcare services and technology company, that just announced its KetaDASH subsidiary will begin using precision medicine techniques to improve patient outcomes through its partnership with HaluGen Life Sciences Inc. psychedelics genetic test kit. 

KetaDASH will use HaluGen’s expanded psychedelics genetic testing panel to test patients. The panel analyzes a series of relevant DNA biomarkers and utilizes pre-screening mental health surveys to provide insights into an individual’s risk and potential of adverse reactions with the use of ketamine. 

For example, the gene mutation CYP2B6 can influence the metabolism of ketamine for the 10-20 percent of people that carry a specific CYP2B6 gene variant. And the HTR2A gene mutation, which is carried by approximately 20 percent of the population, can impact how a person responds to serotonin, which is the primary mechanism of action for serotonergic psychedelics such as psilocybin, LSD, and DMT

For now, advancing precision medicine for psychedelics is all about collecting more data through other research sources following a broader agenda. At the Johns Hopkins’ Center for Psychedelic and Consciousness Research, researchers are focusing on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health, and say that they hope to create precision medicine treatments tailored to the specific needs of individual patients.

Beyond just psychedelics, utilizing precision medicine for all types of healthcare needs is the goal behind the National Institutes of Health’s (NIH) “All of Us” research program. It’s designed to gather health data from one million or more people living in the United States to accelerate research that may improve health by collecting data on biology, lifestyle and environment to help with any and all drug formulation. 

The program is working through 29 institutions and an integrated NIH database of nearly 100,000 genome sequences, survey responses from nearly 330,000 participants, and information from 214,000 electronic health records, alongside physical measurements and wearable device data.

The next digital frontier in precision medicine is quantum computing (QC), according to a McKinsey and Company report. “The molecules (including those that might be used for drugs) are actually quantum systems; that is, systems that are based on quantum physics. QC is expected to be able to predict and simulate the structure, properties, and behavior (or reactivity) of these molecules more effectively than conventional computing can,” according to the report. “Quantum computing could be the key to the exponentially more efficient discovery of pharmaceutical cures and therapeutics as well as to hundreds of billions of dollars in value for the pharma industry.”


Dave HodesJune 8, 2022
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10min9270

You’ve read the predictions, you’ve heard the buzz—psychedelics are about to change the world of mental health treatment. 

They promise no more mental health pharmaceuticals that numb out the brain, or that help mask the side effects. No more taking chemicals for the rest of your life that are not body-friendly, with the caveat that psychedelics can also cause brief, uncomfortable events during treatment on their way to profound, life-changing results.

Want to jump into these turbulent waters of starting up and building a psychedelics business developing drugs for treating mental health conditions? Here are five ways to go about it.

  1. First, get a million dollars. Or even $2 million dollars. Or better yet, $5 million. Yes, this business is expensive. Getting startup money from a venture capital investor is no simple matter because the payoff for them is still relatively uncertain and, at best, years away. They have to be informed gamblers, and you have to have a convincing business plan or model for your business where you can show all the expected results of what their money is buying—which for now, is simply the research and development structure for your company, including clinical trials which can take years and cost millions of dollars to complete. Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies. The FDA can put a hold on a clinical trial if they don’t like how it’s proceeding. That being said, the top 11 VC firms invested about $139.8 million in 2020-2021, according to Business Insider. So apparently, even among the clinical trial uncertainty and the sometimes slow-moving FDA approval process, they clearly see a path to profitability.
  2. Find and sign up the best medical minds you can afford. It’s all about the molecule, man. Identifying and developing small molecules and macromolecules that might help cure illnesses and diseases is the core activity of pharmaceutical companies. There are good scientists out there who see the possibilities of psychedelics for treating mental health. What you want is a scientist with a serious pedigree who you can afford. Someone who has done a lot of work already in psychedelics through some academic facility. Someone who still has a good working relationship with that institution. You need a name to hang your expectations on, and a molecule your medical team can find and patent. And yes, the medical team people are not cheap either. You may be able to work out a sort of shared development deal with the medical director or their team where they continue on with their work at a university but still provide you the name and assistance you want as you build your company. One example is Matthew Johnson, the professor of Psychiatry and Behavioral Sciences at Johns Hopkins University, who is one of the world’s most published scientists on the human effects of psychedelics; was 2019 president of the Psychopharmacology and Substance Abuse Division of the American Psychological Association; and is currently president of the International Society for Research on Psychedelics, an organization he founded with colleagues. He is a clinical advisor for MindMed (NASDAQ: MNMD), a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders that is one of the top five psychedelics companies to watch this year.
  3. Understand your risks as a startup in an emerging industry. There are more and more startups getting into psychedelics now. Some will succeed. Most will fail. The failure rate is high for any small business, let alone one in a challenging emerging market. As of 2021, 20 percent of small businesses failed in the first year, 50 percent within five years, and 65 percent within 10 years. Some fail after multiple clinical trials that didn’t quite work out. But their research has been done and maybe another startup can buy that company’s research as a sort of jump start for their new business. Do your research about strategies for success in this industry. And remember: Many mainstream pharmaceutical companies are still sitting on the sidelines waiting out more regulatory approvals when it comes to psychedelics. If these guys are hesitant, that may be your clue to wait out developments as well before jumping in.
  4. Carefully decide if and when you want to go public. Once a company decides to move forward with an IPO, it must work with an underwriter (typically a bank or multiple banks) to create a prospectus, according to The Motley Fool. A prospectus is a detailed financial report designed to help potential investors make informed decisions. One of the disadvantages of going public is that it takes six to nine months to go through the process, and it costs money to go through with an IPO from financial service and underwriting fees to filing fees. Then once it goes public, the company has to publish their unvarnished financial information, and answer to shareholders, which can create different management headaches.
  5. Don’t give up. It’s a bumpy road. You are going to experience failures. You are going to experience poor management decisions. This is just the way it goes with a novel therapeutic based on an illegal substance in an emerging market. There are many different state and federal laws to work with, and a developing regulatory environment that could take an unexpected turn and put your business at risk. You will need to prepare for these and other growing pains that are common in emerging industries. Seek legal help to build in a safety net. And always, always protect your patent and any related intellectual property which is easier said than done. Some psychedelics were criminalized for decades, the U.S. Patent Office does not have the personnel with expertise in the field, increasing the likelihood of granting meritless psychedelic patents, according to an essay in the Harvard Law Review. And because Indigenous communities pioneered many aspects of modern psychedelic therapies, their patenting by Western corporations may promote biopiracy, or the exploitation of Indigenous knowledge without compensation. Plus, the control of psychedelics by a small number of companies may stifle innovation and reduce access to these therapies.

Dave HodesJune 7, 2022
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10min8160

Another sure sign that psychedelics are gaining momentum in mainstream medicine is how government officials and lawmakers are reacting to the surge of interest from the public.

For example, in May, U.S. Senators Brian Schatz (D-HI) and Cory Booker (D-NJ) wrote a letter to Lawrence A. Tabak, the acting director National Institutes of Health (NIH), and Dr. Robert M. Califf, the commissioner of the U.S. Food and Drug Administration (FDA) referencing a January workshop on psychedelics by the National Institutes of Health (NIH) and encouraging both the NIH and FDA “to further expand their role in identifying research gaps, potentially promising therapeutic uses of psychedelics, and regulatory hurdles in the field of psychedelic research.” That January workshop, they wrote, marked another positive step by the NIH in understanding the benefits of psychedelics.

They also cited work by the NIH in April 2021, when it awarded its first grant dedicated to medicinal psychedelic research with psilocybin. The senators then asked both agencies about any upcoming research, collaborations, and regulatory barriers.

Congressman Earl Blumenauer (D-OR), who has been promoting legalizing cannabis for years, and has been battling the Drug Enforcement Administration (DEA) about cannabis scheduling and law enforcement, circulated a letter in December asking for signatures to petition the DEA to make psilocybin available for patients. 

Blumenauer was involved in the Oregon Measure 109 authorizing the Oregon Health Authority (OHA) to create a program to permit licensed service providers to administer psilocybin-producing mushroom and fungi products to individuals 21 years of age or older. The measure passed on November 3, 2020, making Oregon the first state to legalize psilocybin. “We need more and better research (for psychedelics), first and foremost,” he said, speaking during the launch of the Project on Psychedelics Law and Regulation (POPLAR), a three-year initiative by the Harvard Law School to examine the ethical, legal, and social implications of psychedelics research, commerce, and therapeutics. “It needs more scientific rigor,” Blumenauer said.

Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), said MAPS has a program as part of their psychedelic harm reduction work to make drug policy work by consulting with and having a training program for police in Denver about what to do if they see someone having a difficult psychedelic experience. “We are going to do a pilot program of about 100 and if that works we will sign a contract do about 3,000 first responders in Denver,” he said at the POPLAR launch event. “We hope to do that in Oregon and elsewhere.” 

All those actions are the result of the steady drumbeat to decriminalize psychedelics, beginning with Denver in May 2019, which has been pushed by advocates to the top of the agenda for some lawmakers with varying degrees of success. There are a dozen cities and states that now have laws about decriminalizing psychedelics. Efforts to decriminalize continue in New York, Vermont, California, Utah, Missouri, Connecticut, New Jersey, Texas, Florida, and Hawaii.

But obstacles remain. 

One recent example comes from California State Senator Scott Wiener who introduced Senate Bill 519 in February 2021 to decriminalize not just psilocybin but also dimethyltryptamine (DMT), ibogaine, lysergic acid diethylamide (LSD), 3,4-methylenedioxymethamphetamine (MDMA) and mescaline in California.

That bill was put on hold in August 2021, and appears to be stuck in a stalemate. It is set to be revived sometime in 2022, according to Weiner speaking at the POPLAR launch event. 

The bill’s authors noted that the savings to the state for the decriminalization of those psychedelics would be $1 million if “just five fewer people are sentenced to state prison.” Opposition to the bill claimed that “there is evidence that the hallucinogenic effects of LSD can fuel murders and reportedly there have been at least 11 homicides involving LSD. Hallucinations can be dangerous to users and bystanders alike, and it is not clear that the benefit of legalizing these drugs outweighs the cost to the common welfare.”

But on another political level, psychedelics have been portrayed as having the power to change political viewpoints, effectively making people less authoritarian and more liberal thinking, leading to a more progressive and inclusive society. 

However, there are other historical examples where people with authoritarian views remained unaffected by psychedelic experience, or even developed authoritarian views after or with the assistance of a classic psychedelic. The jury is still out on this particular issue.It is imperative to address these blind spots to advance coherent, interdisciplinary socio-political frameworks for analyzing and engaging with the experiential realities and potential implications of psychedelic drug use,” one study concluded.

Doblin himself has advocated for a broader political and sociological change he believes can happen with psychedelics, saying that there is a fundamental unity with the processes of nature and the functioning of the universe that people can experience through psychedelics. “I think this will have profound political implications once we realize our intimate connection to nature, to global warming, to the environment, to other species, to other people that look different than us who have different religions or different gender orientation,” he said during the keynote for POPLAR. “I think this fundamental unity is what psychedelics will help people experience. So this is the political theory behind what we are trying to say. Which is that the more people we can help experience this fundamental unity, the better off we will be.” 

 


Dave HodesJune 3, 2022
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14min11820

The conditions that psychedelics can treat have doubled in the last few years to include migraine headaches, Parkinson’s disease, autism, alcoholism, drug addiction, gambling addiction, and more. 

But one of the more intriguing conditions that researchers are looking at is Alzheimer’s disease, a disease that has evaded the best efforts of treatment by medical science since it was first discovered in 1906, named after German physician Dr. Alois Alzheimer. 

The disease affects 6.2 million Americans; global cases are forecast to be over 150 million by 2050, nearly triple the number in 2019.

Finding treatment for Alzheimer’s has been the focus of growing government assistance for years, most recently when a $350 million increase for Alzheimer’s and dementia research funding at the National Institutes of Health (NIH) was signed into law in 2019, bringing the annual funding to $2.8 billion. 

Slow Alzheimer’s Progress

But progress toward a treatment has been slow going.

For example, on June 7, 2021, U.S. Food and Drug Administration (FDA) approved aduhelm (aducanumab) for the treatment of Alzheimer’s using the accelerated approval pathway, which can be used to advance research for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. 

Aduhelm offered a brief glimmer of hope with claims that it could actually slow the progression of the disease. But after backlash from the medical community (in part because of a common side effect of swelling in areas of the brain, with small spots of bleeding), restrictions on its use by Medicare, and questions about the FDA’s approval process, the pharmaceutical company that makes aduhelm, Biogen (NASDAQ:BIIB), essentially dropped it in May, 2022. (Biogen is reportedly working on another formulation for treating Alzheimer’s). 

That failure to bring to market the first approved Alzheimer’s drug in 20 years by a well-capitalized biotech company that posted $11 billion in revenue in 2021 has served to incite more activity in alternative therapies—such as psychedelics—to save the day and change the Alzheimer’s treatment narrative going forward. 

In fact, the psychedelics industry has been flirting with finding a successful treatment for Alzheimer’s since 2015, years before Biogen took their shot at a drug, when Eleusis, a life science company based in London and New York, conducted two clinical trials of lysergic acid diethylamide (LSD) focused on establishing a basic framework for the future clinical development of psychedelics in the context of Alzheimer’s disease and depression.

On the surface of the issue, Big Pharma appears to have the upper hand for now. In 2020, there were 121 therapies in clinical trials for Alzheimer’s disease.

And there is a handful of big mainstream biotechnology companies still pursuing Alzheimer’s drug development—including Cassava Sciences (NASDAQ: SAVA), moving forward with their phase 3 studies of Alzheimer’s; Annovis Bio (NYSE: ANVS), announcing in May positive feedback from the FDA for two phase 3 clinical trials with their Alzheimer’s and Parkinson’s drug, buntanetap; and Alector Therapeutics (NASDAQ:ALEC), with three Alzheimer’s programs in the pipeline—two in partnerships with one of the largest pharmaceutical companies, Abbvie, which has $50 billion invested in overall research and development for various classes of pharmaceuticals.

Other biotech businesses pursing Alzheimer’s treatment are Biohaven Pharmaceuticals, AZ Therapies, VTV Therapeutics, AgeneBio and others, all showing little or no success so far, effectively causing biotech businesses to put Alzheimer’s work on the back burner.

The World Health Organization registry shows that there were 170 drugs in development for Alzheimer’s worldwide in 2020, contrasting with 433 for diabetes. Pfizer reportedly completely abandoned Alzheimer’s research in 2018 and laid off 300 employees. It’s this sort of disparity that reflects biotech’s problems: limited availability of biomarkers, longer trial durations, greater expense, and higher risk of failure of Alzheimer’s drug development programs, according to a study published by the Alzheimer’s Association.

Psychedelics Tackle Alzheimers

Psychedelic companies are sensing an advantage now to come up with an Alzheimer’s treatment that stands up to the challenges of both FDA scrutiny and patient benefit. Treatment for this disease is right in its wheelhouse. 

Studies with psilocybin and LSD, coupled with anecdotal reports of cognitive benefits from micro-dosing, suggests that psychedelics may have a therapeutic role in a range of psychiatric and neurological conditions due to their potential to stimulate neurogenesis, provoke neuroplastic changes and reduce neuroinflammation—what mainstream pharma has been attempting to do with their newer chemical concoctions to treat Alzheimer’s over the last five years. Psychedelics also induce brain plasticity and modify connectivity between brain regions which is thought to help patients with Alzheimer’s. 

In fact, all known genetic and environmental risk factors for Alzheimer’s are associated with increased inflammation, suggesting that reducing inflammation could be a target for preventing Alzheimer’s. Psychedelics have been shown to have potent anti-inflammatory properties and may represent a unique anti-inflammatory overwhelmingly targeted to brain tissue. “This inevitably makes them (psilocybin and LSD) interesting candidates for therapeutics in dementia,” a study concluded.

So it seems that biotech businesses have tried and failed to find a treatment for Alzheimer’s, and it’s time for psychedelics to take their shot.

In December, 2021, Mynd Life Sciences (CSE: MYND) (OTC: MYNDF) acquired Cava Healthcare Inc., a life sciences company based in Surrey, British Columbia, which included all future worldwide rights relating to the use of psychedelics to treat Alzheimer’s disease and other dementias.

And right now, there are three psychedelics clinical trials running or recruiting participants for studying the effect of psychedelics on Alzheimer’s, including one sponsored by Johns Hopkins University using psilocybin to see if it’s safe and effective for depression in people with mild cognitive impairment (MCI) or early Alzheimer’s disease. 

The study will also assess whether psilocybin may improve an Alzheimer’s patient’s quality of life. The study began in March, 2021 with results expected in late December, 2023.

Other psychedelics companies in the race for an Alzheimer’s treatment include Ixtlan Bioscience, based in Tel Aviv, which recently announced a new patent for psilocybin treatment of Alzheimer’s.

For now, it’s a sort of standoff: take one of the usual six medications for treating the symptoms of Alzheimer’s and suffer through side effects of nausea, increased bowl movement, vomiting and loss of appetite. Or accelerate the trials and spread out the funding to more psychedelics companies to finally arrive at a psychedelics-assisted therapy that treats the symptoms without a list of grim side effects—going far beyond anything that mainstream medicine has available now for Alzheimer’s. 

Could psilocybin, or LSD, or some new related psychedelic formulation yet to be discovered stop the progress of this terrible neurological disorder? Could they even reverse it altogether? For the first time in a long time, that possibility is not as improbable as it used to be.


Dave HodesJune 2, 2022
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16min7190

The psychedelic experience is intense.

As much as it can help someone understand and work through their mental health issues, the hallucinations that come with them are a significant part of the psychedelics experience that is what makes psychedelics the powerful and effective therapy that it is.

But as the industry evolves and looks to broaden the appeal of psychedelics, work is underway to change or even eliminate the hallucinogenic part of the experience.

To be sure, psychedelics are among the safest known classes of central nervous systems drugs that one researcher says may be the oldest class of psychopharmacological agents known to man.

One new way to modernize them into mainstream medicine use would be to offer a shorter or even absent hallucinogenic effect, which makes for shorter treatment periods and therefore less cost for the patient. That would also make taking psychedelics less risky for both the patient and the medical provider, while also increasing the likelihood of a buy-in from Big Pharmabecause a completely non-hallucinogenic psychedelic could even be taken by a patient at home just like any other pharmaceutical.

Better management or even eliminating the hallucinogenic effectin a clinical trial today could bring in more participants, since vetting potential participants in clinical trials means excludinganyone with a personal or family history of psychotic disordersthat could be exacerbated by the hallucinogenic experience.

Although research has shown that hallucinogens do not cause any physiological damage, adverse issues such as the so-called “bad trip” do occur, characterized by anxiety, fear, panic, and paranoia. This could be a brief experience, or could lead to prolonged psychosis. Researchers are still not sure why or how that happens in some individuals and not others, but reports like this do cause some patients who could benefit from psychedelics therapy to consider a different, more mainstream pharmacological approach.

The range of subjective experience under hallucinogens can be remarkably broad, a study noted, and clinical trial participants need to be made aware that sometimes people experience extremely convincing sensations of dissolving, melting, exploding—and are advised that the best way to deal with all such situations is to surrender to the experience, subjectively allowing themselves to dissolve, melt, or explode.

Surrendering to the experience—simply letting go of their need for experiential avoidanceis not something that people with mental health issues do easily, and in many cases, is an action that becomes totally reliant on where they are and who is monitoring them.

Then there are the cautions about negative interactions with psychedelics from other drugs, such as lithium, and even problematic reactions with dietary supplements like St. John’s Wort.

Work today with strong mind-mining medicines like psychedelics follows a carefully constructed process with strict guidelines to ensure a safe and effective treatment, such asestablishing trust and rapport between session monitors and volunteer before the session; creating a safe physical session environment; and providing interpersonal support from at least two study monitors during the session, according to one study. “Persisting adverse reactions are rare when research is conducted along these guidelines,” the study reported. “Incautious research may jeopardize participant safety and future research.

It’s this “incautious research” issue that is driving a movement to create a non-hallucinogenic psychedelic and find a way of giving the patient the important benefits of hallucinogens without actually experiencing them.

Those specific hallucinogenic benefits in today’s psychedelics-assisted therapy are important, because even in cases where individuals reported strong ratings of fear or anxiety, the majority of these sessions were still judged as personally meaningful, and no volunteer rated the experience as having decreased their sense of wellbeing or life satisfaction.

But participants still had be ready to experience an uncomfortable moment or two, and still had to rely on a monitor to help them understand and ride through those sometimes scary feelings.

For all these reasons, and to help bring more focus to the medicinal side of the psychedelics experience, scientists have begun engineering psychedelics without hallucinogenic qualities.

For example, research on tabernanthalog—a water-soluble, non-hallucinogenic, non-toxic analogue of ibogaine that can be prepared in a single stepdemonstrated that, through careful chemical design, it is possible to modify a psychedelic compound to produce a safer, non-hallucinogenic variant that has therapeutic potential.

Other recent work with mice has shown that its possible to create psilocybin and LSD without the hallucinogenic effect.

Another study with mice used a sensor—called psychLightthat glows in the presence of an hallucinogenic compound when it interacts with a serotonin receptor. It’s been used to identify previously unknown hallucinogenic drugs.

These next generation non-hallucinogenic psychedelics arebeing called a game-changer in psychedelic therapy, with companies such as Delix Therapeutics stepping up to the challenge of developing them. According to David Olson, co-founder and chief scientific officer of Delix, it is important to determine whether or not the molecular and circuit-level mechanisms mediating the hallucinogenic and antidepressant effects of psychedelics are distinct in an effort to better understand the neurobiology of mental illnesses. From a clinical perspective, the implications are huge,” he said in an interview last year for Technology Network’s Neuroscience News and Research publication. While I am very hopeful that compounds like psilocybin will one day be approved for treating depression or perhaps other brain disorders, I suspect that these hallucinogenic molecules will only be used as a last resort for a variety of reasons.”


StaffJune 1, 2022
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Novamind Inc. (CSE: NM)(OTCQB: NVMDF) reported its financial results for the fiscal third quarter ending March 31, 2022. Novamind reported total revenue of $3,227,352, an increase of 32% over the previous quarter. The company had a net loss of $2.4 million. Numinus Wellness will be buying Novamind in an all-share transaction.

Novamind said it had total working capital of $3,928,642 to fund operations. It also closed a $5,000,000 private placement with an institutional investor.

Novamind CEO, Yaron Conforti, commented, “Once again, we’re pleased to report record-high revenue this quarter. Growth was driven by our recent expansion to Arizona in addition to the continued progress of our Utah operations. With the anticipated shareholder approval of the acquisition of Novamind by Numinus in June, the Company is well-positioned to continue this record growth in pursuit of its mission to responsibly reintroduce psychedelic therapy to mental healthcare.”

Quarter highlights included:

  • Closed the acquisition of Arizona-based Foundations for Change, Inc., a mental health practice specialized in ketamine-assisted psychotherapy
  • Opened the Company’s eighth integrative psychiatry clinic, located in Phoenix, Arizona
  • Launched Groups by Novamind, an expansion of the Company’s clinical care model focused on increasing patient access to mental health treatments
  • Novamind’s strategic partner, Bienstar Wellness Corp., signed a letter of intent to acquire BRC Saude Mental E Terapias Assistidas Ltda., a leader in specialized ibogaine treatments for substance use disorder based in Sao Paolo, Brazil

The company also said it was contracted to provide clinical research services for the following clinical trials:

  • A phase IIb randomized clinical trial investigating lysergic acid diethylamide (LSD) for generalized anxiety disorder in adults, sponsored by MindMed
  • A phase II clinical trial investigating psilocybin for major depressive disorder, sponsored by the Usona Institute
  • A phase II clinical trial investigating ketamine-assisted psychotherapy for adults with life-threatening illnesses, sponsored by the Ketamine Research Foundation
  • A phase I clinical trial investigating the safety and efficacy of ketamine-assisted psychotherapy combined with Mindfulness-Oriented Recovery Enhancement therapy for the treatment of adults with opioid use disorder
  • A phase II clinical trial investigating an antidepressant medication for adults with major depressive disorder and PTSD, sponsored by Alto Neuroscience
  • A phase II randomized clinical study for the acute treatment of social anxiety disorder, sponsored by Bionomics

StaffJune 1, 2022
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4min8100

Wesana Health Holdings Inc.  (CSE: WESA; OTCQB: WSNAF) announced its first-quarter 2022 financial results with no revenues to report. Wesana had a net loss of $4.8 million in the quarter. It has a cash balance of $3.1 million. Wesana said it is reviewing strategic alternatives including, but not limited to, a sale of all the assets under the care delivery division, including:

  • Wesana Clinics – a network of psychiatrist-led mental health clinics focused on serving the community through the delivery of personalized innovative psychiatric care, inclusive of ketamine therapy, medication management, psychotherapy, cognitive testing, and pharmacogenetic testing.
  • Wesana Solutions – a medical-grade clinical SaaS platform focused on improving mental healthcare through facilitating access to leading-edge clinical protocols and tracking their efficacy. In concert with EMRs and practice management systems, Wesana Solutions is intended to be used in clinics delivering psychedelics and related therapies, targeting the developing international psychiatric clinic and research market. 
  • PsyTech Connect – a leading community for the clinical use of psychedelics with over 8,000 actively engaged professionals.

Bronstein Out As Chairman

Chad Bronstein has tendered his resignation as Executive Chairman to pursue other professional opportunities. Wesana’s Board of Directors’ appointed Daniel Carcillo as Chairman. Bronstein was instrumental in the founding of the Company as well as in its first years of growth. His commitment to Wesana over the past two years helped the company go-public on the Canadian Securities Exchange and raise $17 million in capital, to initiate the FDA drug development and approval process.

“I am incredibly proud of the company that we have built and the progress we have made to date,” commented Mr. Bronstein, “and I look forward to seeing the continued evolution of Wesana under Daniel’s leadership as the Company moves towards advancing its clinical development program and human clinical trials in the coming months later this year.”

Focus on FDA Studies

On March 14, 2022, Wesana reported it received a full written response from the FDA regarding their pre-IND meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (“TBI”) related MDD. “The Company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence clinical studies for SANA-013. The written response provides a path to agreements on IND-enabling studies and validates the team’s recent effort and accomplishments. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD.” Wesana said it intends to initiate its in-human clinical study program in late 2022.

 


Dave HodesJune 1, 2022
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14min15400

There are 20,000 drugs in active development globally. More novel drugs made their market debut in 2020 than in any other year, with 82 released onto the market in total, which is way ahead of the previous record of 68 in 2018. 

The world pharmaceutical market was worth an estimated $1.2 trillion in 2020 and is one of the most profitable industries in the world.

And as well as Big Pharma is doing today, even with its share of failures, it is ready and waiting for the next big thing: a psychedelic drug that does what no other pharmaceutical can do for treating a growing range of mental health conditions, potentially representing billions in profits.

Big Pharma

Big Pharma company leaders know that people suffering from depression or PTSD, for example, are tired of the whole pharmaceutical runaround—taking a certain prescribed drug for depression, then taking another drug to counter the side effects of that depression drug—in an endless cycle of drug-taking for the rest of their lives.

These patients are getting relief, yes, but only because the usually recommended pharmaceuticals are numbing their brains or masking the signs of their afflictions, essentially addicting them to a chemical regimen that could cause more mental or physical damage in the long run. 

But today, better tuned-in science appears to be supporting psychedelics for the treatment of these afflictions. Participants in one clinical trial with psilocybin reported only mild-to-moderate headaches, with researchers concluding that this intervention may be more acceptable to patients than widely prescribed antidepressant medications that “confer substantially more problematic effects (such as suicidal ideation, decrease in sexual drive, and weight gain). The effectiveness of psilocybin therapy after a single or only a few administrations represents another substantial advantage over commonly used antidepressants that require daily administration.”

Big Pharma is closely monitoring, and in some cases, carefully partnering with psychedelics companies to do more research and development into psychedelics to find better ways of administering them—such as creating psychedelics that have a non-hallucinogenic experience, or using other stronger psychedelics such as N, N-dimethyltryptamine (DMT) in controlled settings that allow shorter durations of therapy and help save the patient time and money. 

Big Pharma doesn’t like some of what it sees—they would like more rigor in clinical trials, and they know that there are significant constraints in developing a drug for the central nervous system that must cross the blood-brain barrier all humans have for limiting the entry of toxins, pathogens, and blood cells to the brain. 

And psychedelics researchers urge caution in going too fast too soon. Fred Barrett, a cognitive neuroscientist with training in behavioral pharmacology who has been conducting psychedelic research at Johns Hopkins University since 2013, told Chemical and Engineering News that psychedelics aren’t miracle drugs. “I think there has to be a little bit of tempering of enthusiasm here. We really need to be careful not to begin to treat these things as a panacea,” he said.

Big Pharma is seeing the psychedelics industry slowly conform more to their model of pharmaceutical development: broadening the number of participants, making psychedelics research more understandable to them, and taking the mystery out of toying with powerful, naturally occurring substances that are being shown as better ways of overcoming difficult and sometimes complicated unmet medical needs. 

As a result, Big Pharma collaborations and connections and partnerships with psychedelics companies have begun in earnest.

Psychedelic Partnerships

One example: Beckley Psytech Limited, a private company dedicated to addressing neurological and psychiatric disorders through the application of psychedelic medicines, and Lophora ApS, a drug discovery company working in the central nervous system arena, just announced they have entered into a research and development collaboration. Under the terms of the agreement, Beckley Psytech will jointly fund continuing development of the Lophora pipeline and collaborate broadly on research and development.

Another: In January, Mindset Pharma’s CEO James Lanthier told Forbes that their deal with Otsuka Pharmaceutical, a huge multinational drug development company headquartered in Tokyo working to find novel drugs for treating conditions of the central nervous system, where a division of the company gave MindSet $5 million to help with psychedelics research and development, is the first partnership between a category-leading pharmaceutical company and a psychedelic biotech company focused on new psychedelic drugs. “Our partnership with them is significant as the combination of funding and Otsuka’s operational expertise significantly increases the likelihood of success for our new drug programs,” Lanthier said.

And U.S. pharma monster company Merck, with $48.7 billion in sales in 2021, is working with Novamind (OTC: NVMDF), a mental health company using psychedelic medicine through a network of clinics and clinical research sites, on a clinical trial focused on treatment-resistant depression. The main purpose of this study is to assess the efficacy and safety of daily and intermittent dosing of Merck’s MK-1942 drug formulation compared to placebo among participants with treatment-resistant depression (TRD) on a stable course of antidepressant therapy. The trial will be done at Novamind’s subsidiary, Cedar Clinical Research, the same clinic where Janssen Pharmaceutical Company developed Spravato in March 2019, a nasal spray for treating depression that is widely considered the first psychedelic medicine to be approved by the FDA.

“The stigma has certainly worn off,” Yaron Conforti, the CEO, and director of Novamind said in a YouTube video on their website. “I think that there is a vision broadly for the sector and for our company that we like to see a future where people interact as a patient with mental health in psychiatry much as they do with their chiropractor or cardiologists for that matter. That is a fairly simplified statement I just made but when you factor in what is required to get to that point, there is a lot of heavy lifting,” Conforti said. “The new therapies coming online are also focused on very particular indications of patient groups, as MDMA focused on PTSD for example. I think that mobilizing an entire patient group and providing them with access to an alternative therapy that has proved to be very safe and efficacious is going to have an enlightening effect.”

For now, as Big Pharma eyes psychedelics and builds a rationale for inclusion with psychedelics, there is still much that needs to be worked out even on a very basic level. 

For example, Big Pharma’s intrigue with psychedelics could be tempered by ongoing studies comparing the usual mainstream pharmaceuticals with psychedelics, such as the case with one study demonstrating that a common anti-depressant pharmaceutical currently on the market (escitalopram) fared no better than psilocybin in treating depression, except perhaps in the side effects category (which includes headache, nausea, diarrhea, dry mouth, increased sweating, feeling nervous, restless, fatigued, or having trouble sleeping). “But the analyses of these outcomes lacked correction for multiple comparisons,” researchers concluded. “Larger and longer trials are required to compare psilocybin with established antidepressants.”

Mark Wingertzahn, chief science officer at Wesana Health, told Pharmaceutical Executive magazine that companies like GSK and Pfizer once had very large development programs in [mental health]. “But these research efforts have largely been shelved due to the lack of novel drug candidates with a better safety and efficacy profile compared to today’s antidepressants,” he said. Wesana is developing a drug to deliver a novel depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a non-hallucinogenic dose of psilocybin combined with cannabidiol (CBD). “Once everyone believes psychedelics may be the future of mental health treatment, then it becomes like any other drug that is currently being evaluated under drug development principles in that area,” Wingertzahn said. “This will enable us to generate hard data to allow regulators and clinicians to ascertain patient populations that may experience the most benefit from this ‘new’ old class of agents.”


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