The psychedelic drug market continues to follow a similar path to the cannabis segment. It is now slowly getting more attention from investors as the stigma surrounding psychedelic drugs fades. In particular, the growing acceptance of using psychedelics to treat various mental disorders such as depression is actually fueling market growth. Recently, a total of three breakthrough therapy designations have been awarded by the FDA to psychedelic assisted therapy clinical trials for psilocybin and MDMA. The designations could potentially help shorten the development timelines of these psychedelic focused clinical trials, positively affecting patients suffering from depression and PTSD in the long run. And, according to Data Bridge Market Research, the North American psychedelic drugs market is expected to gain market growth in the forecast period of 2020 to 2027, growing with a CAGR of 15.8% in the forecast period and is projected to reach USD 6,846.68 Million by 2027. Mind Medicine (MindMed) Inc. (OTC: MMEDF) (NEO: MMED), Revive Therapeutics Ltd. (OTC: RVVTF), AbbVie Inc. (NYSE: ABBV), AstraZeneca PLC (NASDAQ: AZN), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)
While psychedelic drugs like psilocybin are classed as schedule III-controlled substances under Canada's Controlled Drugs and Substances Act (CDSA), recent exemptions have moved the needle on how such products can be legally administered. The exemption, granted last year, is allowing approved applicants with terminal illnesses to have psilocybin administered. "The Minister's exemption marks the first time a legal exemption has been granted in Canada for patients to access psychedelic substances for treatment. The four individuals suffer from terminal cancer and have experienced anxiety etc. that have not responded to conventional psychotherapy treatments. They applied for an exemption under compassionate grounds under section 56(1) of the CDSA," according to Wise Health Law.
Mind Medicine (MindMed) Inc. (OTCQB: MMEDF) (NEO: MMED) announced last week that it has, "streamlined its leadership team to further develop the company's strategy of integrating its psychedelic clinical development programs with innovative digital technologies."
J.R. Rahn will take on sole responsibility as Chief Executive Officer of the Company and Perry Dellelce has been appointed as Chair of the board of directors. This evolution of executive management will bolster MindMed's strategy with a team that includes Dr. Miri Wernli Halperin as President and Head of Clinical and Carol Nast as Chief Operating Officer, as well as Robert Barrow who was recently hired as Chief Development Officer to expand on the company's later stage clinical trial pipeline and drug development efforts at the FDA. Before joining MindMed, Robert Barrow helped gain a Breakthrough Therapy Designation for a Phase 2 trial of psilocybin in Major Depressive Disorder at the FDA.
Under the MindMed 2.0 leadership team, the company is also actively growing its digital medicine division for psychedelic medicines through the hiring of new technologists and undertaking potential technology platform acquisitions.
J.R. Rahn said: "As we increase our headcount and grow our MindMed 'Ark' of technologists, drug developers, scientific researchers, regulatory experts, psychiatrists and drug manufacturing specialists, the entire psychedelic medicine space is edging closer to getting these potential medicines into the hands of patients. In doing so, we must also turn our efforts and open our unified strategy to technology, distribution platforms and other growth opportunities to remain a leader in this space. Our streamlined leadership team and MindMed 2.0 strategy will continue to help define MindMed as a leader in the psychedelics space and as a specialist in digital medicine."
MindMed is currently working on two Phase 2 commercial clinical trials based on the psychedelic substance LSD for anxiety disorders and Adult ADHD. In addition, the company is also planning a Phase 2 study of a substance derived from the psychedelic substance ibogaine to treat opioid withdrawal.
Revive Therapeutics Ltd. (OTC: RVVTF) announced back in November that an update on its oral thin-film delivery system with psilocybin being developed under a research partnership agreement with Reed Research Group out of the University of Wisconsin-Madison. Following several months of prototyping on a wide range of dosage forms, the Company has completed an oral thin-film strip product with psilocybin with dosage forms ranging between 1 mg and 20 mg and demonstrating its versatility through physio-chemical characterization (e.g. tensile strength of films) of bio comparable tannin-chitosan composite materials, dissolution and disintegration testing, and rate of psilocybin release from composites. Currently technical and scientific data is being processed and finalized.
AbbVie Inc. (NYSE: ABBV) announced back in May last year that it has completed the acquisition of Allergan. As a result, AbbVie has gained access to Allergan's ketamine-like drug for depression, which has secured the FDA's coveted breakthrough therapy designation, guaranteeing the company access to top agency officials as it moves toward late-stage development.
AstraZeneca PLC (NASDAQ: AZN) and Yale University researchers tested a compound known as lanicemine (developed by the company) on 152 depressed patients at 30 different clinics. Fifty patients underwent intravenous therapy with a placebo saline solution. The other 102 were split into two groups, with each group receiving a different dose of the ketamine mimic. Compared to the placebo, the compound showed rapid and significant antidepressant effects that lingered for several weeks following a three-week dosing period. "Clearly, there's a huge unmet need for depressed patients," said study co-author Gerard Sanacora, director of Yale's Depression Research Program, back in 2013. "Here at Yale, we're very interested in exploring novel treatment strategies, and so we're very interested in these compounds."
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. Last yeah, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, outlined a new statistical method to analyze future Posttraumatic Stress Disorder (PTSD) drug studies and presented a retrospective analysis using the new method of the Phase 3 HONOR study (P301) of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), for the treatment of military-related PTSD. "The paradox that confounds modern PTSD studies is that the placebo response has increased over time, even as we and others have striven to improve study methods and data quality," said Dr. Lederman.
For more information about Mind Medicine (MindMed) Inc. click here.
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