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New York, NY – January 19, 2022 – After facing legal scrutiny for decades, psychedelics including MDMA and psilocybin received a stamp of approval from Health Canada for medical purposes. Canada’s legislation now permits the use of psychedelics beyond palliative care, something health advocates are calling a major breakthrough in treating serious or life-threatening conditions. This news is great for patients interested in psychedelic treatments for mental illness and will likely offer companies Compass Pathways (NASDAQ:CMPS), ATAI Life Sciences (NASDAQ:ATAI), Revive Therapeutics Ltd. (OTCQB:RVVTF), Mind Medicine (MindMed) (NASDAQ:MNMD) (NEO:MMED), and Numinus Wellness (TSX:NUMI) (OTCPK:NUMIF) who are conducting clinical trials on various psychedelics a smoother pathway to approval.
Numinus Wellness (TSX:NUMI) (OTC:NUMIF) helps people heal through the development and delivery of innovative mental health care. This includes access to safe, evidence-based psychedelic-assisted therapies. The company’s business model focuses on psychedelic production, research, and clinical care to heal symptoms for illnesses such as depression, anxiety, trauma, pain, and substance use.
On January 18, Numinus Wellness announced that it has completed the necessary steps to begin enrolling participants for its MAPS Public Benefit Corporation study, a multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX). The study received regulatory approval from Health Canada, along with ethical approval from an Institutional Review Board (IRB). It was also granted a Section 56 exemption from the Controlled Drug and Substance Act to allow the use of MDMA to test the safety and efficacy in treating severe PTSD throughout the duration of the clinical trial.
MAPS is the leading developer of MDMA-assisted therapy training programs, treatment protocols, and research. In December, Science Magazine designated MAPS’ MDMA-assisted therapy for PTSD among its top ten Scientific Breakthroughs of the Year in 2021. Numinus will host the Canadian sites for MAPPUSX in Quebec and British Columbia, which will be managed through Numinus’ two new, purpose-designed clinics, allowing for quick completion of the MAPS trial in Canada.
Numinus Wellness, which recently graduated to the TSX, also just announced that it has submitted the clinical trial application (CTA) to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone solidifies and further progresses the company’s long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.
Approvals, Trials, and Progress in New Treatments Using Psychedelics
Compass Pathways (NASDAQ:CMPS) is a mental health care company accelerating patients’ access to innovation in mental health. On January 4, the company shared results of a Phase 1 study displaying the feasibility of administering COM360 psilocybin to up to six healthy participants simultaneously. This study was an initial demonstration that the simultaneous administration of psilocybin is worth exploring further.
Atai Life Sciences (NASDAQ:ATAI) is a clinical-stage biopharmaceutical company transforming the treatment of mental health disorders. On January 12, the company announced that the Food and Drug Administration (FDA) gave the company Investigational New Drug (IND) clearance to conduct a clinical DDI study of PCN-101 (R-ketamine). The study is planned to begin in early 2022 through Atai’s platform company Perception Neuroscience. atai sees this as a promising candidate for a potentially rapid-acting antidepressant with more favourable safety and tolerability than S-ketamine. This could eventually enable at-home use, for patients who require ketamine treatment for severe depression or other mental illnesses.
Revive Therapeutics (OTCQB:RVVTF) (CSE:RVV) provided the status of its Phase 3 clinical trial for Bucillamine in COVID-19, revealing that 700 participants took part in the enrollment period. The specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders. By Mid-February, Revive expects to begin subject enrollment in Turkey, and to complete enrollment in the Phase 3 clinical trial sometime in Q1 2022. The company’s advancement of this trial and its potential COVID-19 treatment will continue to be reported in the coming quarters as the Phase 3 trial continues.
Mind Medicine Inc. (NASDAQ:MNMD) (NEO:MMED) just completed its Phase clinical trial of 18-MC, which is a non-hallucinogenic proprietary derivative of ibogaine. The company is developing this treatment for indications linked to opioid use disorder. Completed in December 2021, the topline results of the trial are expected in early 2022. This marks another milestone for the trial, and the company will also announce the results of the Phase 1 study in the coming months, according to Robert Barrow, Chief Executive Officer and Director of MindMed.
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