Awakn Life Sciences Archives - Green Market Report

Dave HodesOctober 10, 2022
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13min13790

There’s been a steady surge of interest in how and why psychedelics work to potentially cure addiction, especially alcohol addiction, also called alcohol use disorder (AUD). It is becoming one of the more interesting developments that mainstream medicine is watching, as more and more evidence becomes available.

In fact, it was LSD that was the original psychedelic substance researchers hoped to use to treat AUD, with some clinical success between 1966 and 1970But as with much of the current psychedelics clinical trials, there is more to learn about which psychedelic is best, and how it works, for treating AUD. 

New NYU Studies

According to a new study by the NYU Grossman School of Medicine, psilocybin may play a crucial role in treating AUD. In the study, 93 men and women with alcohol dependence were given two doses of psilocybin—83 percent reduced their heavy drinking within an 8-month period. The study concluded that psilocybin administered in combination with psychotherapy “produced robust decreases in the percentage of heavy drinking days over and above those produced by active placebo and psychotherapy,” and the results “provided support for further study of psilocybin-assisted treatment for AUD.” Researchers also said that this AUD research may prove useful in treating other addictions such as cigarette smoking and abuse of cocaine and opioids.

Michael Bogenschutz, director of the New York University (NYU) Langone Center for Psychedelic Medicine and senior author on the study, said that NYU would launch a multisite trial with more than 200 participants starting early next year and, depending on the results, planned to eventually submit the treatment to the Food and Drug Administration (FDA) for approval. NYU also filed a provisional patent application based on the work, he added in an interview for Stat News

AUD is one of the most prevalent mental disorders globally. According to the 2019 National Institute on Alcohol Abuse and Alcoholism (NIAAA), 14.5 million people ages 12 and older had AUD. Worldwide, alcohol use has increased over the past three decades and is expected to continue to do so, both in its prevalence and level of use.

According to the NIAAA, the latest science shows that AUD can cause lasting changes in the brain. And there are only four well-known pharmacological treatments approved for AUD—Disulfiram, Acamprosate, Naltrexone, and Nalmefene—each chalking up only modest success.

So the race is on now to find the best psychedelic for treating AUD, in what could be one of the more lucrative specialized psychedelic drug markets yet. 

Awakn Life Sciences

Awakn Life Sciences Corp. (NEO: AWKN)(OTCQB: AWKNF), a biotechnology company researching, developing, and commercializing psychedelic therapeutics to treat addiction with a focus on AUD, says that treating alcoholism is a multi-billion-dollar industry that “lacks efficacy and innovation.”

The company has two AUD programs: ketamine-assisted therapy, and MDMA-assisted therapy. They recently secured funding from Innovate UK, the British government’s innovation agency, to identify the quickest and most cost-effective route to market in both the UK and the U.S. for their ketamine-assisted therapy for treating AUD.

Awakn’s lead clinical development program on the biotech research and development side of the business is proprietary ketamine-assisted therapy for alcohol use disorder. Awakn has a Phase IIb clinical trial already completed. 

The focus on ketamine is because it’s an anesthetic, so it naturally dulls any sense of anxiety. And the ketamine experience is only 90 minutes long, unlike MDMA or LSD where treatments can go on for hours. 

“What’s really important to notice is that people actually coming into our trial were sober 2 percent of the time,” co-founder and CEO of Awakn, Anthony Tennyson, told Psychedealia. “So they were sober seven days a year. And we got them to the equivalent of 320 days a year sobriety,” he said. “If you think of the positive impact on the liver, kidneys—everything, all bodily systems—that is significant.”

Awakn is treating people in three clinics that they own and operate with the therapeutic approach developed in their Phase IIb trial. “What we’re now doing is also out-licensing that to other people’s clinics to empower them to provide hope for individuals, families, and communities who are suffering with addiction, and for which the current treatments are just not working.”

What Awakn’s researchers are finding out about AUD and other types of addictions is that there are three levels to the human brain—a lower-level function, a mid-level function, and an upper-level function, Tennyson said. 

Brain Functions

Lower-level functions are learning memory and reward prediction. Mid-level functions are marked by attributions for the importance someone puts on previous experiences or predicted future experiences. Upper-level functions are the mind and the cognitive control in a balanced brain. “The analogy I use is that the upper-level functions as software, and lower and middle are where the hardware is in a balanced brain or a non-addicted brain. The software maintains control over the hardware. What happens with repeated exposure to addictive substances, and also what our team has discovered that applies to other addictive behaviors like gambling or pornography, is that the upper-level software loses control over this hardware.”

For example, with alcohol addiction, the site of a bar triggers the memory that has been learned about a predicted future reward in the opioid receptor in the alcoholic’s brain. Alcohol interacts with that triggering and gives the alcoholic pleasure.

Awakn uses psychedelics to disrupt the connections between those brain circuits and the operations within those circuits, to sort of “take those parts of the brain offline.” In the space that disruption provides, psychotherapy is used to enable people to forgive themselves, but also develop much more dynamic and better coping mechanisms to fight off and fight against the urges to relapse.

The Awakn treatment has a three-step protocol: a prep session, a ketamine session, and an integration session. “The prep session is about bringing the issues to the surface, such as what life experience, what trauma, what decisions did you go through for you to end up where you are today,” he said. 

Memories are brought out by a qualified psychotherapist, then those memories are disrupted during the ketamine experience. “As they (the memories) are laid back down, they are laid back down in a fragmented way, and they become less impactful and potentially less triggering for you. Ketamine kicks the brain into a state of neurogenesis, so there are new neural connections forming.” 

Awakn is also working with MDMA in conjunction with psychotherapy for addiction treatment. “MDMA switches off the fight-or-flight mechanism,” he said. “So if a childhood trauma or an adolescent trauma contributed to you being addicted, you can access those traumatic memories without the body clamming up and you walk out the door. It enables you to forgive yourself, to like yourself, but also most importantly, to potentially forgive whoever inflicted the trauma on you.”

So far, according to an article published in Addiction Biology journal, the data collected from various studies about AUD demonstrates that these psychedelics—ketamine, psilocybin, and MDMA, plus ayahuasca and mescaline—are in fact good candidates for treating excessive alcohol consumption and that it’s important to note that no study showed an increase in alcohol consumption as a consequence of psychedelic use. “This is contrary to the effect shown by other psychoactive substances such as nicotine, cocaine, amphetamine, cannabinoids, morphine, or caffeine, which have been shown to increase alcohol consumption,” the article added, concluding that data from these studies presented some “methodological concerns” that make it difficult to draw definitive conclusions, including lack of control over the administered dose.


Adam JacksonSeptember 15, 2022
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3min2200

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) posted positive results as revenue rose along with patients — showing the growing demand for psychedelics-centered therapy to treat addictions. The Canadian biotechnology company released its financial report card for the second quarter ending July 31.

Awakn posted revenues of C$339,872 via Awakn’s clinics for the second quarter, versus no revenue in the prior year. The second quarter revenue is up C$86,718, or 34% over the quarter.

The company said that revenue “during the seasonally quietest period of the year for our services” was primarily driven by the provision of ketamine-assisted therapies at the London, Bristol and Oslo Awakn clinics. These clinics were not open during the equivalent period last year.

“Today’s results and revenue growth demonstrate the continued momentum building in our business and the successful execution of our business plan in both pillars of the business: R&D and Commercialization,” CEO Anthony Tennyson said.

Over the quarter, Awakn received approval for its Phase III clinical trial for ketamine-assisted therapy for the treatment of Alcohol Use Disorder. This is the first time a government agency has funded a Phase III trial in psychedelics.

The company received C$2.5 million from U.K.’s National Institute for Heal and Care Research to cover 66% of the costs of the trial. The company will bankroll the rest.

“We have also made excellent progress in strengthening the IP moats for our ketamine and MDMA programs,” Tennyson said, referring to the competitive advantage of its intellectual property.

The company had C$481,830 in cash. It also announced the closing of a private placement – issued 1,880,454 units at a price of C$0.55 per unit raising gross proceeds of C$1,034,250.

“We have also successfully launched our licensing partnership business into the U.S. and Canada, putting us in the unique position of being a biotech with commercial operations in four territories, the U.K., the U.S., Canada and Norway, in only our second full financial year,” Tennyson said

Through the rest of the fiscal year, Awakn said it anticipates receiving regulatory and ethics approval for its Phase III clinical trial for ketamine-assisted therapy, as well as completing its behavioral study of ketamine in gambling addiction.

The company will also look to further its therapeutics commercialization through acquiring more licensing partners utilizing the company’s intellectual property moat ketamine-assisted therapy for treatment of Alcohol Use Disorder in the U.S. and Canada.


StaffJune 15, 2022
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3min2380

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 HodesMarch 28, 2022
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6min2320

Human beings seek treatment for any addiction to any substance (or any behavioral act) that is affecting their social development and their ability to lead a productive life.

While these issues have been part of mental health treatment for decades, there is still much work to be done.

Enter the psychedelics industry, which is discovering new ways to tackle tobacco addiction with psilocybin (with tobacco cessation studies piling up new data), drug addiction (findings that psychedelics can replace opioid use), and other behavioral addictions.

Alcohol addiction has been added to the list of psychedelics therapy through the focused work of Awakn Life Sciences (OTC: AWKNF) a Vancouver-based biotechnology company founded in June 2020, that is researching, developing, and delivering psychedelic therapeutics to treat addiction, including the treatment of alcohol use disorder (AUD).

Awakn was reportedly created when founders bought a controlling stake in Dr. Ben Sessa’s private practice, Mandela Therapy Limited. Sessa is now the co-founder and chief medical officer of Awakn.

AUD is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. Considered a brain disorder, AUD can be mild, moderate, or severe. Lasting changes in the brain caused by alcohol misuse perpetuate AUD and make individuals vulnerable to relapse, adding to the treatment difficulty.

In mid-March, Awakn Clinics in London got Care Quality Commission’s (CQC) formal approval to begin treatments for addiction and mental health. This flagship clinic is Awakn’s third clinic, adding to the company’s two operating clinics located in Bristol, England, and Oslo, Norway.

The clinics use ketamine-assisted therapy to treat addiction and several mental health disorders, including AUD, using a treatment protocol developed in their recently published Phase II a/b clinical trial.

This study demonstrated that treatment with three infusions of ketamine was well tolerated in patients with AUD and was associated with more days of abstinence from alcohol at the 6-month follow-up.

In February, Awakn filed a patent application for a new chemical series of entactogen-like molecules. Entactogen-like molecules are a class of psychoactive substances that produce distinctive emotional and social effects that Awakn believes have the potential to treat both substance and behavioral addictions, according to a press release.

These molecules have the potential to treat addiction by delivering improved efficacy in a shorter treatment time.

As a result of that discovery about Entactogen-like molecules, it’s not just alcohol addiction that Awakn is working on. In January, the company decided to expand its existing ketamine study to include three other behavioral addictions, including binge eating disorder, compulsive sexual behavior, and internet gaming disorder. To back up the need for expanding in these new directions, Awakn cites facts that binge eating disorder affects up to 110 million people globally; internet gaming disorder affects 238 million, and sexually compulsive behavior affects up to 350 million.

The expanded study is to be led by Celia Morgan, Awakn’s head of ketamine-assisted therapy for addiction, and a professor of psychopharmacology at the University of Exeter, U.K. Morgan will investigate a new treatment approach for these behavioral addictions, exploring and monitoring whether ketamine can increase neuroplasticity using electroencephalogram (EEG).

With ground-breaking work like this in its future, Awakn is seen as one of the top psychedelics companies in the industry.

But like many psychedelics companies, Awakn is still in the clinical trial stage of psychedelics development. It trades on both the NEO and the OTCQB and is generally trending down these days, as are a lot of psychedelics. Awakn recorded its first revenue hit of $31,737 in late 2021. But there is still a lot going on with the company.

On the plus side, Awakn’s recent acquisition of the exclusive rights to MDMA research from Imperial College London to investigate the role of MDMA-assisted psychotherapy in treating patients with AUD is seen as a giant step forward in treating alcoholism.

And finally, Awakn has arguably one of the strongest science and research teams in the business, including Chief Research Officer David Nutt, psychiatrist and the Edmund J. Safra Professor of Neuropsychopharmacology in the Division of Brain Science, Dept of Medicine, Imperial College London; and Chief Scientific Officer Shaun McNulty, who has over 25 years of industry experience in the neuroscience drug discovery units of a major pharmaceutical company, including Parke-Davis, Pfizer, and GSK. It’s that sort of firepower that keeps investors on the alert about Awakn’s future.


Dave HodesFebruary 15, 2022
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8min2140

While there is more and more work on psychedelics to treat people for drug and tobacco addiction, it’s treating alcoholism that is gaining new interest from psychedelics researchers today. But finding that specific psychedelics treatment to slow down alcoholism, or even stop it completely, continues to be a head-scratcher for psychedelics researchers. 

Help is desperately needed. Alcoholism is more destructive than ever today. According to the National Institute on Alcohol Abuse and Alcoholism, there are 95,000 alcohol-related deaths in the U.S. each year, making alcohol the third-leading preventable cause of death in the U. S. (the first is tobacco). 

More concerning is an emerging trend to high-intensity drinking—drinking alcohol at levels that are two or more times the gender-specific binge drinking thresholds.

As evidence of this growing alcoholism problem continues to pile up, a number of new studies and surveys on psychedelics and alcoholism have emerged over the last few years. 

One recent study that examined the role ketamine plays as an effective treatment in alcoholism has caught the attention of psychedelics researchers everywhere.  

It’s one of the first studies in the world to explore the effects of serial ketamine infusions in combination with psychotherapy to treat alcohol use disorder (AUD) over a 6 month follow up period, sponsored by Awakn Life Sciences (OTC: AWKNF) and led by Celia Morgan at the University of Exeter. The study was published in the American Journal of Psychiatry in January, 2022. 

The Phase II study involved 96 participants with severe AUD who were required to abstain from alcohol for at least 24 hours prior to undergoing the randomization process, which allowed the researchers to examine the effects of ketamine on prolonging abstinence. 

In a double-blind placebo-controlled trial, the patients were randomly assigned to different ketamine infusions combined with therapy. They were able to abstain from using alcohol for a set period of time—before relapsing.

This ketamine research supports the belief that psychedelics can absolutely play a role in successfully treating alcoholism. 

Researchers have also found that psilocybin may reduce alcohol use, and that perhaps ibogaine and ayahuasca can help as well since they have shown promise in the treatment of various addictions through observational studies. But exactly how they work and what they can do is still not known.

Psychedelics researchers have been circling the alcoholism treatment issue for years, dating back to 2013, when the potential of psychedelics to treat addictions was first considered. 

One of the first clinical trials with psilocybin, for instance, was a proof-of-concept study done in 2015 to quantify the effects of psilocybin in alcohol-dependent participants, and to provide preliminary outcome and safety data. 

Ten volunteers were given psilocybin in one or two supervised sessions, in addition to therapy sessions devoted to preparation for and debriefing from the psilocybin sessions. 

Abstinence from drinking alcohol increased significantly following psilocybin administration. But the study’s authors admitted this was just the beginning. “These preliminary findings provide a strong rationale for controlled trials with larger samples to investigate efficacy and mechanisms,” the study authors concluded.

More controlled trials on using psilocybin to treat alcoholism have been done over the last four years than during any other period before. Researchers hope they are zeroing in how it can help.

In one study, participants said that psilocybin helped them with “acute and lasting alterations in their perceptions of self, in the quality of their baseline consciousness, and in their relationship with alcohol and drinking.”

A recent study with lab rats used psilocybin to lower the cravings for alcohol, lessen alcohol-seeking behavior, and reduce the risk of relapse. 

LSD has also been considered as a treatment for alcoholism as well. An anonymous online survey by Johns Hopkins researchers in 2019 of 343 people with drinking problems who took LSD on their own found that it helped them slow down their alcohol consumption or stop it altogether. “These results suggest that naturalistic psychedelic use may lead to cessation or reduction in problematic alcohol use, supporting further investigation of psychedelic-assisted treatment for alcohol use disorder,” the survey authors concluded.

Experiments with zebra fish and microdosing LSD to treat alcoholism are also showing promise. And mescaline was recently discovered as another psychedelic that could help.

But for now, psychedelics researchers admit they are stumped. They can’t say for sure what characteristics of a psychedelic experience can or should lead to the changes in alcohol addiction, even calling for using machine learning to analyze written reports of psychedelic experiences that may allow for accurate prediction of alcohol-quit outcomes within psychedelic therapy.


Debra BorchardtJanuary 11, 2022
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5min1070

Awakn Life Sciences Corp. (OTCQB: AWKNF) reported positive data from its Phase II A/B trial. It was the first controlled trial to investigate Ketamine-Assisted Therapy for the Treatment of Alcohol Use Disorder (AUD), the results have been published in the American Journal of Psychiatry. Awakn said the double-blind placebo-controlled trial included 96 patients with severe AUD, who were randomized to one of four groups: 1) three ketamine infusions (0.8 mg/kg IV over 40 minutes) plus proprietary manualized therapy (KARE); 2) three saline infusions plus KARE therapy; 3) three ketamine infusions plus alcohol education; and 4) three saline infusions plus alcohol education.

The findings showed that ketamine combined with KARE therapy, resulted in total abstinence in 162 of 180 days in the following 6-month period, achieving an increase in abstinence from around 2% prior to the trial to 86% post-trial. The results for relapse at 6 months, showed that the Ketamine plus KARE group’s risk of relapse was 2.7 times less than the placebo plus alcohol education group.

“Alcohol Use Disorder is a pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post-treatment tend to be high. We urgently need new and more effective treatments,” said Prof. Morgan. “We found that controlled, low doses of ketamine combined with manualized psychological therapy can significantly increase post-treatment abstinence rates. This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within twelve months of treatment. The data we’ve collected from this study paves the way for a paradigm shift in how AUD is treated.”

Prof. Morgan identified further significant results in the reduction in heavy drinking days. At six months post-trial, there was an average of 12 heavy drinking days in the Ketamine plus KARE group, this is a large reduction compared to other trials in this area and it is widely believed the real-world data is far higher than this. Within the KARE group, there was also a significant decrease in the risk of mortality, 1 in 8 patients would have died within 12 months without treatment, that number decreased to 1 in 80 following the treatment. In total, the trial demonstrated that three subanesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy. No serious adverse events took place during the trial.

Anthony Tennyson, Awakn’s Chief Executive, added, “We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them. We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry.”

The company said the trial was conducted by the University of Exeter (UoE) and led by Professor Celia Morgan, Awakn’s Head of Ketamine-Assisted Therapy for Addiction and Professor of Psychopharmacology at UoE. Awakn acquired the intellectual property (IP) to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally. The positive Phase II trial outcome and Awakn’s newly formed partnership with the UK National Healthcare Service (NHS) and UoE, paved the way to progress this trial into Phase III. With the ultimate aim of securing regulatory approval for Ketamine-Assisted Therapy to treat AUD in the UK through the NHS and potentially in other territories.

 

 


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