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New York, NY – March 30, 2022 – Depression and anxiety affect millions around the world and the venom of a toad is the latest psychedelic compound being used as an alternative treatment. The Sonoran desert toad is the only animal on earth that produces 5-MeO-DMT, a potent chemical psychedelic that could potentially offer a “full central nervous system reset” like it did for Marcus Capone, a Navy SEAL who was previously suffering from crippling depression and anxiety. Of course, the substance 5-MeO-DMT is just one of the many alternative therapies being tested for the treatment of illnesses including anxiety, depression, and addiction. Companies like Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF), Seelos Therapeutics (NASDAQ:SEEL), Mind Medicine Inc. (NASDAQ:MNMD) (NEO:MMED), Mydecine Innovations Group (NEO:MYCO) (OTCPK:MYCOF) (FSA:ONFA), and Compass Pathways (NASDAQ:CMPS) are developing a wide range of potential psychedelic-based treatments and therapies for the multi-billion dollar psychedelic drugs market.
Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF) just announced that it has advanced to the next implementation phase in its multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX), a clinical trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) and organized by MAPS Public Benefit Corporation (MAPS PBC), by enrolling and dosing the first clinical trial volunteer in Canada.
Numinus hosts the Canadian sites for MAPPUSX, through two purpose-designed clinics located in Montreal and Vancouver. This week, the Montreal site began drug administration, led by trial co-therapists Dr. Joe Flanders, VP Psychology at Numinus, and Dr. Emma Hapke, Staff Psychiatrist, University Health Network and Principal Investigator for the MAPS-sponsored trial. The treatment follows MAPS’ protocol of three sessions of MDMA administration and therapy, followed by three integration sessions, with the full program expected to complete in mid-summer 2022.
Numinus is also making progress at its state-of-the-art bioscience research facility, Numinus Bioscience. On March 9, the company announced that it has received approval from Health Canada to study Ayahuasca and San Pedro at the facility. This license is critical for the company in positioning Numinus Bioscience as a global research center for natural psychedelic medicines.
Since 2020, Numinus Bioscience has continuously expanded its license to widen its range of research activities. Prior approvals include the possession, analytical testing, production, assembly, sale, export and delivery and study of DMT, Ketamine, LSD, MDMA, Mescaline, Psilocin, Psilocybin.
Then on March 14, 2022, Numinus announced that Numinus Bioscience had been approved by the Public Health Agency of Canada for a Containment Level 2 (CL2) pathogens and toxins license, following an upgrade of the facility. This will allow the company to provide novel data on natural psychedelics, present additional intellectual property opportunities, and a further revenue driver through contract research services from other companies.
Numinus’ license will allow the company to move forward with the study of pathogens and bacterial, fungal and microbial contaminants to identify baseline markers and optimal growth environments for Psilocybe mushrooms; bioassay studies using mammalian cell lines, to analyze the bioactivity of different whole mushroom formulations that contain both psilocybin and other psychedelic compounds; and pharmacokinetic (PK) and pre-clinical studies using analysis of blood and other bodily fluids, to investigate reactions in the human body to whole mushrooms and other natural formulations
This license, along with the Controlled Drugs and Substance Dealer’s License from Health Canada has shown Numinus to be a key center for natural psychedelic research. The goal for the company is to bring much of its psychedelic research from theory to practice through Numinus Bioscience.
For more information about Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF), click here.
Biopharmaceutical Companies Run Clinical Trials for Various Psychedelic Formulations
Seelos Therapeutics (NASDAQ:SEEL) granted a stock option to purchase 75,000 shares based on its 2019 inducement Plan. The biopharmaceutical company focused on developing therapies for central nervous system disorders and rare diseases granted this stock option as an inducement plan for new employees entering employment with the company under Nasdaq Listing Rule 5635 (c)(4). The stock option is available at a share price of $1.65 per share.
Mind Medicine Inc. (NASDAQ:MNMD) (NEO:MMED) has received clearance from the FDA for its Investigational New Drug (IND) application. Following this clearance Mind Medicine can now proceed with the phase 2b dose optimization trial for MM-120 in the treatment of generalized anxiety disorder – a condition that affects about 6% of the US adult population. The company expects to continue with the trial early in 2022.
Mydecine Innovations Group (NEO:MYCO) (OTC:MYCOF) recently submitted a pre-investigational new drug briefing package to the FDA for its Phase 2/3 clinical study to assess the safety and efficacy of psicocybin-assisted psychotherapy to treat tobacco addiction. The company also appointed Dr. Victoria Hale as an independent member of the Board of Directors who brings additional experience in drug development and the psychedelics industry. In addition to being an independent member of the company’s Board, she is the Chair of the Board of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit that raises awareness in psychedelics and supports scientists as they design, fund, and obtain regulatory approval for their psychedelic research.
On February 24, Compass Pathways (NASDAQ:CMPS) announced its financial results for the fourth quarter and full year 2021 including business highlights from the last few months. The company reported positive results from phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression (TRD) as well as positive results from its open-label study of 25mg COMP360 psilocybin therapy as adjunct to SSRI antidepressants in TRD. Compass also launched its phase II study of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and is well capitalized to continue its R&D with a year-end 2021 cash position of $273.2 million.
As companies like Numinus advance research and development efforts on the effectiveness of psychedelic treatments, they create an opportunity for the effective treatment of mental health conditions.
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