psychedelics Archives - Green Market Report

StaffStaffSeptember 10, 2020
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6min5831

Havn Life Sciences announced that, on August 31, 2020, its wholly-owned subsidiary, HAVN Research Inc., was granted a Section 56 exemption by Health Canada, meaning it now has the ability to possess certain amounts of pure psilocybin for scientific purposes, specifically for the research and development of quality control methods.

Havn Life said it plans to immediately begin work on experiments with the objective of developing a set of methods for the safe, standardized, quality-controlled production of medical compounds extracted from the Psilocybe spp. mushroom.
“We are thrilled to be among the first to receive permission from the Canadian government to begin work with psilocybin”, stated Tim Moore, Co-CEO of Havn Life. “This important milestone will enable Havn to begin working toward creating method-validation and analytical chemistry to standardize methods for quality control and testing of these substances.”
“Having access to compounds is essential in order to further research in the medical field. This is the start of our journey into developing standardized protocols to ensure that as this industry grows, we understand efficient new methodology”, stated Susan Chapelle, Havn Life Co-CEO, noting the advent of new technology and variables in extraction have changed significantly in the last decade.

Havn recently began trading on the Canadian Securities Exchange using the ticker symbol “HAVN”. Havn Life said it is focused on the standardized, quality-controlled extraction of psychoactive compounds from plants and fungi to develop products for use in research. Havn Life is also developing natural healthcare products designed to unlock human potential, containing novel and natural psychoactive compounds. The company has no revenue as of yet.

“Listing on the Canadian Securities Exchange is an important step in Havn Life’s growth within the emerging global psychedelic space,” says Tim Moore, Havn Life Co-CEO. “There is a tremendous opportunity to transform and enhance the healthcare and wellness space with psychedelic medicine, and the time is now to lay the foundations for what is likely to be a significant industry. Our multidisciplinary team is focused on laying the groundwork by developing quality controls and methodology for research and the medical supply chain.”

Moore was the only employee of Havn when the prospectus was published. Havn Research has a staff of seven, comprising seven consultants and no fulltime employees. Havn Research said it has the qualified personnel required to operate its facility and to develop research protocols and formulate drug compounds

Psilocybin Research

According to the company’s prospectus, Havn Research plans to undertake research to develop the research protocols to cover the production of Psilocybe spp. mushrooms in sterile conditions, the extraction and purification of psilocybin, psilocin, baeocystin, and other compounds found in the genus, and quality control and testing necessary for safety and formulation protocols with Psilocybe spp. and/or constituents. Havn Research said it plans to develop a compound library designed to support the science of safe, quality-controlled psychoactive compounds for the formulation to supply researchers with compounds for clinical trials.
Havn Research said it expects that it will take one year to complete the development of research protocols, after which
approximately an additional four months will be required for the protocols to be published. Havn Research’s research is expected to be split into two 17-week phases and one 18-week phase. The company said it plans to build a dedicated lab facility for its research, formulation, extraction, and pilot-scale manufacturing purposes.
The phase 1 lab build-out is anticipated to cost $300,000 and to be completed by the beginning of the third quarter of 2020. Phase 1 will be designed to meet the requirements to operate under the Health Canada section 56 research exemption. The Corporation also plans to complete a phase 2 lab build-out designed to satisfy the requirements necessary for a Dealer’s License, which it aims to complete by the first quarter of 2021. The phase 2 lab build-out is anticipated to cost $500,000. Havn said it expects it will take an additional four months for the protocol to be published.
HAVN Research aims to have natural health products (NHP) ready for the market in early 2021. HAVN Research said it expects to market its proprietary NHP products under the HAVN brand through a direct to consumer market model and through third party point of sale locations of NHP products.

“We are currently working on a variety of projects including product formulation of effective microdosing of novel psychoactive compounds as well as the development of a state-of-the-art mycology lab for extraction,” said Susan Chapelle, Co-CEO of Havn Life.


Debra BorchardtDebra BorchardtSeptember 4, 2020
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4min3960

Numinus Wellness Inc. (TSXV: NUMI) has filed a final short form prospectus to offers up to 16,000,000 units at a price of $0.25 per Unit for gross proceeds of up to $4,000,000 in the offering jurisdictions of British ColumbiaAlberta, and Ontario. The offering is expected to close on or about September 10, 2020.

Numinus is a company that is creating an ecosystem of health solutions centered on developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies. The company said it would use the net proceeds of the Offering for MDMA and psilocybin Compassionate Access protocol implementation, to make these drugs accessible to specific patient groups before they are available on the market, as more particularly described in the Prospectus.  Additional funds will be used to secure therapy space and develop psychedelic integrative treatment models, support upgrades to its Lab infrastructure to support its Health Canada licenses, and for general operating expenses.

Deal Details

Each Unit will consist of one common share of the company and one-half of one common share purchase warrant.  Each Warrant will entitle the holder to purchase one additional common share of the company at a price of $0.35 per common share for a period of two years from issuance. The company said it has received conditional approval of the Offering from the TSX Venture Exchange, and for the listing of the common shares comprised within the Units, the common shares issuable on exercise of the Warrants and common shares associated with compensation to the Agent.

The Company

Numinus Bioscience includes a 7,000 square foot research and testing laboratory as well as numerous Health Canada licenses (through its wholly-owned subsidiary Salvation Botanicals), including a cannabis testing license that provides established and growing revenue. It is also a late-stage applicant for cannabis processing. Additionally, the company holds a dealer’s license which allows it to import, export, possess, and test MDMA, psilocybin, psilocin, DMT, and mescaline, and it is the first publicly listed company in Canada to be issued a Health Canada license to produce and extract psilocybin from mushrooms for the purpose of developing proprietary extraction methods.

These licenses will allow Numinus to support the growing number of studies on the potential benefits of psychedelic therapies through research projects, product development, and the supply and distribution of these substances. Numinus R&D leverages established relationships to position the Company for partnerships to host studies, develop medical and therapeutic protocols, and influence regulatory approval. Numinus Health, with one clinic already prototyping systems for efficiency and profitability, is dedicated to delivering therapies that enhance and supplement existing options—centered around psychedelic-assisted therapies when and where regulated—for people wanting lasting physical, mental, and emotional health.


Video StaffVideo StaffSeptember 2, 2020

1min2160

MAPS, the nonprofit organization whose moniker stands for Multidisciplinary Association For Psychedelic Studies recently raised $30 million as interest grows in the space. Simeon Schnapper, Managing Partner at JLS Fund has been investing the space for some time. He spoke with GMR’s Editor-in-Chief Debra Borchardt about the opportunities in the industry and why interest is building. Thank you for watching the Green Market Report! Be sure to subscribe to stay up to our channel.


Debra BorchardtDebra BorchardtSeptember 1, 2020
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5min10840

The UK-based mental health company known for its psychedelic treatments, Compass Pathways has filed to go public this week. The company said it plans to list its American depositary shares on the Nasdaq under the ticker “CMPS”. The company reported total net losses of $13.2 million, $19.6 million and $24.8 million, respectively, for the fiscal years ended December 31, 2018 and December 31, 2019 and the six months ended June 30, 2020.

The company has raised $116 million so far. As of June 30, 2020, it had an accumulated deficit of $62.4 million. Its largest shareholder is Atai Life Sciences, which owns 29% of the stock. Other large shareholders include founders George Goldsmith and Ekaterina Malievskaia each with 16.5% of the company. Entities affiliated with Peter Thiel own 7.5%.

Psilocybin Treatments

The company is known for its pioneering the development of a new model of psilocybin therapy, in which psilocybin is administered in conjunction with psychological support. “Our initial focus is on treatment-resistant depression, or TRD, a subset of major depressive disorder, or MDD, comprising patients who are inadequately served by the current treatment paradigm. The company noted in its filing that early signals from academic studies, using formulations of psilocybin not developed by us, have shown that psilocybin therapy may have the potential to improve outcomes for patients suffering with depression, with rapid reductions in depression symptoms and effects lasting up to six months, after administration of a single high dose.” The company noted that the depression market is seen as a $200 billion market.

“We have developed a proprietary, high-purity polymorphic crystalline formulation of psilocybin, COMP360. In 2019, we completed a Phase I clinical trial administering COMP360, along with psychological support, to 89 healthy volunteers, the largest randomized controlled clinical trial with psilocybin therapy to date. In this trial, we observed that COMP360 was generally well-tolerated. We are currently evaluating COMP360 in conjunction with psychological support in a Phase IIb trial and we plan to report data from this trial in late 2021.”

Use Of Proceeds

The company said it will use the proceeds raised to fund clinical trials, therapist training and other activities to support the development of its investigational COMP360 psilocybin therapy through completion of all ongoing trials through the end of Phase II meetings with the FDA. Compass will also fund research and clinical development activities related to its investigational COMP360 psilocybin therapy to support the progression of COMP360 as a therapy for other neuropsychiatric indications and further our mechanistic understanding of psilocybin. In addition, the money will be used to fund general business development activities, including strategic investments.

Phase 2 trials

Compass is currently conducting a randomized controlled Phase IIb clinical trial in 216 patients suffering with TRD, in 20 sites across North America and Europe. This dose-finding trial is investigating the safety and efficacy of COMP360 combined with psychological support, for the treatment of TRD, and aims to determine the optimal dose of COMP360, with three doses (1mg, 10mg, 25mg) being explored. The primary endpoint of this clinical trial is to evaluate the efficacy of COMP360, as assessed by the change in the Montgomery-Åsberg depression rating scale, or MADRS, a widely accepted scale for depression that has been used as a primary endpoint in pivotal trials of other depression treatments. This trial has been designed to capture a statistically significant reduction in MADRS. Compass plans to report data from this trial in late 2021.
“We are using digital technology in this Phase IIb trial, including an online portal to help patients prepare for their psilocybin experience, and a web-based “shared knowledge” interactive platform to complement therapist training. We are also collecting digital phenotyping information through the measurement of human-smartphone interactions. After the trial, these data will be compared with information collected from validated psychiatric scales, such as MADRS, to develop potential digital applications to help anticipate relapse of depression. In the future, we plan to expand our research into additional digital technologies to complement and augment our therapies.”

Debra BorchardtDebra BorchardtJuly 14, 2020
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5min5772

Mydecine Innovations Group Inc. (CSE: MYCO) (OTC: MYCOF) has entered into an agreement to buy Canadian-based NeuroPharm Inc. in a deal valued at roughly $6.3 million. NueroPharm is a  developer of natural psychedelic-based treatments for mental health disorders. Mydecine recently signed an agreement with Applied Pharmaceutical Innovation (API), a translational commercial drug institute at the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences as it makes fast progress in the psilocybin world.

Colonel (Ret’d) Pucci, CEO of NeuroPharm said, “Our mission is to develop and bring to market treatments addressing the mental health conditions frequently experienced by veterans, including PTSD, depression, and anxiety.  We understand the unique circumstances of the veteran community and are devoted to treating these substantial unmet needs.  Our collaborative partnership with Mydecine will accelerate our ability to address the enormous challenge of restoring the overall wellness in the veteran, EMS and frontline personnel communities.”

NeuroPharm said in a statement that it is focused on developing unique and proprietary technologies to treat various mental health conditions frequently experienced by veterans and frontline workers such as PTSD, depression, addiction, anxiety, and panic disorders as well as migraine and cluster headaches. The team is a combination of critically acclaimed scientists and military personnel boasting extensive drug development experience and deep, embedded relationships within the Canadian and U.S. militaries.

It has also established valuable partnerships with leading research organizations in both North America and the EU, and is poised to initiate a series of unique clinical trials this summer.  In conjunction with a preeminent university in the EU, NeuroPharm will be initiating veteran-based clinical trials for the treatment of PTSD with microdosed MDMA/psilocybin formulations.  This inceptive trial will serve as the basis for follow-on trials conducted in Canada and the United States. NeuroPharm’s veteran focus allows for fast-track “adaptive pathways” which should significantly reduce time to market.  

“According to recently published data, as many as 20 veterans on average commit suicide per day in the U.S. alone, and, to me, this is a heart-breaking staggering statistic that unfortunately is overlooked by so many. We owe everything to our veterans, EMS and frontline personnel, yet the best solutions for their long-term mental health are currently non-existent. Aligning ourselves with the amazing team at NeuroPharm affords us the ability to make a positive change,” said Josh Bartch, CEO of Mydecine.

NeuroPharm said it will oversee all areas of the product life cycle, including medical mushroom cultivation, drug delivery system development, clinical trial execution, all the way through to product commercialization. The acquisition will help establish Mydecine plant its flag in psychedelic-based therapies and research.

Deal Terms

Mydecine will give NueroPharm $500,000 when the deal closes and has agreed to fund further capital requirements of NeuroPharm for the 18-month period following closing. Otherwise, it is an all-stock deal. Nine million common shares of Mydecine at a deemed value of $0.70 per payment share will be exchanged with some limitations. The statement said that the Payment Shares issued for seed shares of NeuroPharm shall be subject to restrictions on resale for a period of 24 months from the closing of the acquisition, and will be released in four 25% tranches. The balance of the Payment Shares issuable to NeuroPharm shareholders shall be subject to restrictions on resale for a period of 60 days from the closing of the acquisition. 

Mydecine shall also issue 10 million performance warrants that will be provided to designated officers, employees, and consultants of NeuroPharm and will be paid in tranches when the following goals are met: (i) the successful completion of up to six clinical trials designed to study psilocybin in Veterans suffering from PTSD; and (ii) upon the filing by NeuroPharm of up to five patent applications in Canada and/or the United States relating to the business of NeuroPharm.


Debra BorchardtDebra BorchardtJuly 7, 2020
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4min7360

Despite the continuing opportunities for the cannabis industry, many companies have decided that they don’t want to miss out on the emergence of the mushroom industry. The latest entry to the psilocybin race is CannaGlobal Wellness.

This company is a combination of CannaGlobal, Sansero Life Sciences, and Rise Wellness. The new company said it will focus on psilocybin and other natural compounds to promote emotional, mental, and physical wellness. The company believes that its assembled team of cannabis executives will prove to be a winner in the increasingly crowded space for psilocybin, which is still an illegal substance.

The Team

The company listed the following executives for CannaGlobal Wellness: Lorne Gertner, co-founder of Tokyo Smoke, Cannasat Therapeutics (now Cynapsus Therapeutics), and PharmaCan Capital (now The Cronos Group), will serve as Chairman. Leveraging his vast experience and extensive network in the global cannabis and wellness industries, he founded CannaGlobal to pursue the advancement of cannabis and global wellbeing. Steve Sadoff, co-founder of Sansero, will serve as CEO. Mr. Sadoff has 15 years of experience developing, launching, and growing brands and products within highly regulated environments including nutraceuticals, natural health, and cannabis.

Irie Selkirk will continue to lead Rise Wellness, leveraging her extensive experience as a retailer, patient support expert, and as an educator, facilitator, and leader in the cannabis and psychedelics industries. Dr. Darryl Hudson, Ph.D. Molecular Biology and Genetics, will take on the role of Chief Science Officer, bringing with him a deep understanding and unparalleled expertise in the areas of plant molecular biology, neuroscience, and genetics in cannabis and psychedelics.

“This is a major step forward for mental health in Canada and around the world,” said Gertner. “Psilocybin is proven to have real benefits for treating serious conditions that affect millions of people, and we are excited to be on the cutting edge of helping people improve their lives and making the world a better place, which I am passionate about and have spent the majority of my life pursuing.”

CannaGlobal Strategy

CannaGlobal Wellness said it will bring together Sansero’s science team and capabilities in the development of novel formulations and intellectual property in psilocybin-based treatments, Rise Wellness’ delivery of immersive healing experiences, and CannaGlobal’s network of natural wellness pioneers. The synergies created by this merger will enable the company to offer an extensive and scalable menu of wellness solutions in the short term, while also accelerating the development and commercialization of psilocybin-based neurotherapeutics.

“Three hundred million people worldwide suffer from depression, and one out of 13 people have an anxiety disorder,” Sadoff said. “Without effective treatment, these illnesses can be debilitating, and even life-threatening. But current treatments aren’t universally tolerated and always effective. Our formulations have indicated that psilocybin when combined with natural molecules and world-class immersive healing environments, offers a superior alternative to single-molecule drugs that merely suppress symptoms. This merger gives us the infrastructure and network to bring new, game-changing, neurotherapies to market with maximum efficiency.”


Julie AitchesonJulie AitchesonJuly 6, 2020
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5min9170

Medical cannabis legalization is a fait accompli in thirty-three states and counting and eleven states have legalized recreational marijuana, suggesting a brighter horizon for other restricted plant medicines as well. Enter psychedelic mushrooms, otherwise known as Psilocybe spp., and Susan Chapelle, co-CEO of the newly-launched Havn Life, a company dedicated to developing a range of standardized, quality-controlled psilocybin products to be used by researchers.

Chapelle (whose bio includes being the first female steel rigger in North America, a two-time elected politician, and boasts years spent lobbying for health policy change), launched Havn Life as part of a larger mission to build evidence-informed natural healthcare products that help people manage their own healthcare. 

Developing a reliable, safe, standardized supply of psilocybin, which does not currently exist, is a central part of this broader vision. “A concern that all companies must grapple with as we look to the future of psychedelic medicines is the future of the supply chain,” Chappelle explains. “Havn Life is developing two labs in the South Campus of The University of British Columbia (UBC), where we will develop methodology for growing and extracting Psilocybe spp. These compounds will be available to academics studying psychedelics until policy becomes informed by evidence, and the market opens up to these compounds as approved medication.” But Susan Chapelle and her team do not intend to stop there, she states. “Havn Life is diversified and looking at other psychoactive compounds for use in Natural Health products to get to market using evidence-informed formulations derived from fungus and plants.”

Havn Life’s supply development won’t only benefit their own bottom line, however. “Havn Life is developing a reliable and safe supply chain of psychedelic compounds,” Chapelle says, “an essential component that will enable other companies to move to human clinical trials.” When I asked about the ways in which Havn Life is navigating the regulatory landscape as part of this endeavor, Chapelle informed me that “psilocybin is currently scheduled as a restricted compound by most governments. It is a controlled compound in Canada; however, both animal and human trials can be conducted through an application process to Health Canada. There is still a hangover effect from the ‘war on drugs,’ but ultimately the regulators must absorb the evidence from five decades of clinical research, most of which is peer-reviewed and published.”

Chapelle is unfazed regarding other potential obstacles to realizing her team’s vision for Havn Life. “The amount of collective knowledge and the fact that we are all trailblazers that have worked in nascent industries such as cannabis, technology, and formulations is such an incredible benefit. We have an ability to look at obstacles as challenges to be solved.” With the partnership with the University of British Columbia firmly in place and a diverse team of dedicated professionals, Havn Life’s mission appears anything but impossible. “Civilization has been enjoying mushrooms in both cultural ceremonies and for recreational purposes for eternity,” Chapelle asserts. “Access to a safe, properly dosed, standardized drug supply is long overdue.”

 


Debra BorchardtDebra BorchardtJuly 2, 2020
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5min6850

The star of the quickly growing plant-based medicine field is currently the mushroom – specifically, the psilocybin mushroom. It’s being touted as a treatment for drug-resistant depression and addiction. Clinics are being discussed as places to administer doses of psilocybin, but it seems the non-medical use has been brushed under the rug. A new study explores the case for non-medical psilocybin.

The results published by Psychopharmacology (2020) and led by Carbonaro, T.M., Johnson, M.W. & Griffiths, R.R. studied the subjective features of the psilocybin experience that may account for its self-administration by humans. The test was a double-blind comparison of psilocybin and dextromethorphan (DXM).

Study Results

The researchers were determined to figure out why people wanted to take psilocybin for non-medical uses more than they wanted to take DXM. The study consisted of a single, acute oral dose of psilocybin (10, 20, 30 mg/70 kg), DXM (400 mg/70 kg), and placebo were administered under double-blind conditions to 20 healthy participants with histories of hallucinogen use.

According to the researchers, high doses of both drugs produced similar time courses and increases in participant ratings of peak overall drug effect strength. Nine subjective effect domains are proposed to be related to the reinforcing effects of psilocybin: liking, visual effects, positive mood, insight, positive social effects, increased awareness of beauty (both visual and music), awe/amazement, meaningfulness, and mystical experience.

For most ratings, (1) psilocybin and DXM both produced effects significantly greater than placebo; (2) psilocybin showed dose-related increases; 3, DXM was never significantly higher than psilocybin; (4) the two highest psilocybin doses were significantly greater than DXM. These differences were consistent with two measures of desire to take the drug condition again.

Supported By Other Mystical Measurements

The nine subjective effect domains that psilocybin users experience has been supported by other studies. It was validated in an article published in 2015 by Johns Hopkins Researchers. The researchers took a 30-item revised Mystical Experience Questionnaire (MEQ30) that was previously developed within an online survey of mystical-type experiences occasioned by psilocybin-containing mushrooms. The rated experiences occurred on average eight years before completion of the questionnaire. Their work validates the MEQ30 using data from experimental studies with controlled doses of psilocybin.

The article read as follows: Data were pooled and analyzed from five laboratory experiments in which participants (n=184) received a moderate to high oral dose of psilocybin (at least 20 mg/70 kg). Results of confirmatory factor analysis demonstrate the reliability and internal validity of the MEQ30. Structural equation models demonstrate the external and convergent validity of the MEQ30 by showing that latent variable scores on the MEQ30 positively predict persisting change in attitudes, behavior, and well-being attributed to experiences with psilocybin while controlling for the contribution of the participant-rated intensity of drug effects.

These findings support the use of the MEQ30 as an efficient measure of individual mystical experiences. A method to score a “complete mystical experience” that was used in previous versions of the mystical experience questionnaire is validated in the MEQ30, and a stand-alone version of the MEQ30 is provided for use in future research.

Final Thoughts

Like marijuana legalization, the case for medical use will no doubt push forward the argument for decriminalization and legalization. It is far easier to convince lawmakers of a medical case for legislation versus a mystical experience argument. However, the industry would be remiss to dismiss the non-medical use for psilocybin.


Kaitlin DomangueKaitlin DomangueJune 15, 2020
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5min4600

Mydecine (MYCO.CN) (NLBIF) is quickly upping its fungi authority. The mycology-focused company has signed an agreement with Applied Pharmaceutical Innovation (API), a translational commercial drug institute at the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences. 

Mydecine is a fungi and mushroom cultivator/product development company offering unique research and expertise in their field. Their partnership with API will quickly upgrade their value and already existing knowledge in the mycology arena. API is a sea of experts in this field, and the collaboration will provide the company with the ability to fast track its product development. The experts are knowledgeable in areas like pharmaceutical analysis, discovery, drug action, clinical development, and formulation. The Faculty of Pharmacy of Pharmaceutical Sciences consistently ranks in the top 15 for research citations (essentially the strength of the research) by international QS rankings in pharmacy and pharmacology. In addition, Mydecine will be able to utilize further talent and research capabilities by accessing API’s collaborating institute, Alberta Machine Intelligence Institute. 

The partnership allows the company to commence fungal discovery investigations immediately with varietal mushrooms and their extracts, including scheduled substances. Mydecine is GMP and Health Canada eligible, able to conduct R&D, and perform clinical trials. This allows the company to launch research and work that will take others in their field years to achieve. Research and development are set to begin with a significant focus on extracting, analyzing, determining the effects from various compounds of fungi, and researching dosage forms. This is likely to position the company as a leader in the space for years to come. 

Mydecine entered a two-year contract with API and will be paying a total $1,099,345 in year one and $1,136,249 in year two ending February 1, 2022, with year three and beyond being a right of refusal to either party. 

“We see this agreement as a core component of our work as a company,” says Mydedine CEO Josh Bartch “the API team at the Faculty of Pharmacy and Pharmaceutical Sciences gives us the ability to rocket our product development ahead by years, providing the know-how, facilities, and licenses to quickly establish Mydecine as a leader in naturally sourced therapies for a wide variety of indications. The research division also provides a phenomenal synergy with our other recent acquisitions, giving us a dedicated team to explore myco-inspired treatments particularly for areas of high need such as mental health.”

“Back to the fungal future,” Dr. Neal Davies , Dean, Faculty of Pharmacy and Pharmaceutical Sciences “Pharmaceutical activity of fungal metabolites have been known for at least 15 centuries and contemporary research has discovered some novel molecule leads for unique mycological medications for nature-inspired treatments in the new millennium. This bodes very well for the program developing promising treatments.”

“We’re thrilled to be working with Mydecine,” says API CEO , Andrew MacIsaac , “we see their focus as one of growing importance and high potential that will serve them well. By developing a world-class R&D program that discovers potential new lead compounds, synergistic effects, and increased therapeutic indications for mushroom-derived products, Mydecine will stand out in this burgeoning sector.”


Debra BorchardtDebra BorchardtApril 29, 2020
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7min10220

Specialty life science company Revive Therapeutics Ltd. (CSE: RVV) has said that it will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on its wholly-owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation.

“We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds,” said Michael Frank, Revive’s, Chief Executive Officer. “We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies.”

The company said in a statement that through initial evaluations with its research team, it has found there are several unique parallels between the company’s intellectual property portfolio of psilocybin-based formulations and delivery mechanism and the drug delivery technology, which is comprised of tannin-chitosan composites that have been studied with cannabidiol in the past.  Revive said it intends to research both delivery mechanisms in parallel as each provides its own unique qualities such as the potential of rapid onset of action and time-release compositions.

New Interest in Psilocybin

Psilocybin is being viewed as a treatment for several conditions including drug-resistant depression. Studies have been performed to illustrate the efficacy of psilocybin for this specific purpose. One completed study found that psilocybin produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. The study was published in 2016, and wrote that “At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the high-dose experience, with >80% endorsing moderately or greater increased well-being/life satisfaction.”

According to the World Health Organization, almost 350 million people worldwide were affected by depression in 2016. Common antidepressant drugs help maintain the balance of various hormones and chemicals in the brain, which assists in the treatment of depression.

The Center for Disease Control and Prevention (CDC), reported that the percentage of people above the age of 12 years using antidepressants in the U.S. rose to 12.7% in 2011-2014. According to MedGadget, the antidepressant drug market was valued at $13.69 billion in 2018 and is expected to reach $15.88 billion by 2025. The CDC said that in the U.S., antidepressants were the most commonly prescribed drugs in 2013 and from over 16 million long term users, around 70% are female.

Psilocin Acquisition

In March, Revive completed its acquisition of Psilocin Pharma Corp., a specialty psychedelic sciences company focused on the development of Psilocybin-based therapeutics for significant unmet medical needs including rare and orphan indications. Psilocin developed patent-pending formulation and production solutions for the active compound Psilocybin.  The process encompassed with its intellectual property cover methods of production of Psilocybin-based formulations.

In a statement, the company noted that Psilocin has also developed formulations to date which include the Hydroxy Line.  The line will include PSY-0.1 -Capsules- PSY-0.2 -Sublingual Spray- PSY-0.3 -Gel Cap- PSY-0.4/0.5 -Effervescent Tablets-and PSY-0.6 -Breath Strips.  The precisely dosed formulations will work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to U.S. Food and Drug Administration (“FDA”) approval in the treatment of depression, anxiety, bi-polar disorder, bulimia and anorexia nervosa, and a number of other diseases.  Psilocin’s range of products have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption

Best Delivery Method

Revive believes that the most optimal delivery method to deliver psilocybin will be in the form of both an oral dissolvable tablet and an oral thin film strip, commonly recognized as a ‘Breath Strip’.  The company said that it is preparing its formulation development plans to pursue clinical studies for indications currently not being evaluated with psilocybin.

The company reported that it has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). In addition to those patent applications, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.

The delivery technology is a natural, non-toxic, biodegradable, and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

Revive is also exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza strains including COVID-19.



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