A Toronto-based biotech firm is developing a new psychedelic medicine to cure Alzheimer’s disease, announcing recently that it has gotten approval from Argentina’s regulators to begin a Phase ll clinical study using the Company’s unique psychedelic molecule, BMND08. Biomind Labs is a biotech research and development company looking into new medicines and nanotech delivery systems for a wide range of psychiatric and neurological diseases. The trial looks at whether BMND08, a treatment based on the natural psychedelic chemical 5-Methoxy-N,N-dimethyltryptamine (also known as 5-MeO-DMT or simply DMT), helps treat the depression and anxiety that are typical in Alzheimer’s patients. The Phase ll clinical trial will take place in Argentina, where regulators approved the investigation in May. Although some research has looked into cannabis as a possible cure for Alzheimer’s disease symptoms, Biomind’s study is thought to be the first to explore a psychedelic like DMT. Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF), Seelos Therapeutics (NASDAQ:SEEL), Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF), ATAI Life Sciences (NASDAQ:ATAI), and Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) are other companies developing psychedelic-based treatments.
Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is a homegrown Canadian company producing natural, scalable and accessible psychedelic and functional mushrooms and synthetic formulations for transformational human experiences.
On September 22, Optimi Health announced that in conjunction with ATMA Journey Centers, the companies have confirmed their intention to proceed with a Phase I clinical trial application (CTA) which will document the safety of Optimi‘s natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.
It would be the first experiment approved by Health Canada to evaluate safety and extra markers, such as the mystical experience questionnaire, in healthy participants who have used MDMA.
According to Optimi CEO Bill Ciprick, the purpose of the clinical experiment is to collect data for Optimi’s patented formulation using natural EU-GMP psilocybin and MDMA, such as blood pressure, temperature, heart rate, and ECG measurements. These goods are manufactured and tested in-house at Optimi’s 20,000-square-foot Princeton, British Columbia facility. Ciprick said that the clinical confirmation of their solutions on healthy patients moves them one step closer to commercialization.
“For the thousands of trained professionals waiting to experience natural, EU-GMP psilocybin and MDMA, we share their enthusiasm and believe we have an ethical responsibility to supply them with a life-changing product that is receiving considerable attention from regulatory bodies across the world,” said Ciprick.
Optimi‘s commercialization strategy calls for the company to be a market leader in satisfying therapist demand for natural EU-GMP psilocybin and MDMA.
Optimi will act as the official clinical trial sponsor, according to Ciprick and Harder. At the same time, ATMA will provide clinical research expertise through its medical advisory team led by Dr. Michael Blough. Details of the CTA protocol will be provided once Health Canada issues a No Objection Letter.
The Optimi-ATMA collaboration is designed to broaden the breadth of the relationship, which began with the signing of an initial psilocybin supply deal in June 2022. It will serve as the foundation for the company’s commercial pipeline’s continued development.
Companies Developing Psychedelic-Based Treatments Are Advancing Their Studies
On September 13, Seelos Therapeutics (NASDAQ:SEEL) announced that Acadia Healthcare Company, Inc. has joined the SLS-002 (intranasal racemic ketamine) registration-directed Proof of Concept trial for Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD). Part 2 of Seelos’ registration-directed trial now enrolls patients in a randomized, double-blind, placebo-controlled research. The study’s purpose is to see how recurring doses of SLS-002 (intranasal racemic ketamine) compare to the standard of care for symptoms of MDD and suicidality in people at high risk of suicide.
Takeda Pharmaceuticals (NYSE:TAK) announced on September 16 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of maribavir for the treatment of cytomegalovirus (CMV) infection or disease that is refractory (with or without resistance) to one or more prior therapies, such as ganciclovir, valganciclovir, cidofovir, or foscarnet (SOT). The European Commission (EC) will think about the CHMP’s positive opinion and decide whether to give marketing permission in the coming months. If approved, maribavir would be the first CMV-specific UL97 protein kinase inhibitor used for this purpose in the European Union (EU).
On September 27, ATAI Life Sciences (NASDAQ:ATAI), which is developing EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment of PTSD and other indications, announced that its Phase 1 study has received regulatory and ethics approvals from Medsafe and HDEC, respectively, to begin participant enrollment. The Phase 1 randomized, double-blind, placebo-controlled study aims to assess the safety and tolerability of single-ascending doses of EMP-01 in healthy adult participants, as well as the usability and acceptability of the IDEA-1 app in delivering “set and setting” content to participants before EMP-01 administration. Topline data for this Phase 1 trial are expected in H2 2023.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) presented data from a retrospective observational database study in patients diagnosed with Long COVID at the International Association for the Study of Pain (IASP) 2022 World Congress on Pain, which was held in Toronto, Canada, September 20-23, 2022. The study was inspired by the desire to determine the frequency of symptoms of multi-site pain, exhaustion, and sleeplessness in Long COVID patients, as these are hallmarks of Overlapping Chronic Pain Syndromes such as fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The first participant in the Phase 2 PREVAIL study of TNX-102 SL as a potential treatment for individuals with Long COVID syndrome (Long COVID) whose symptoms overlap with fibromyalgia was enrolled in August 2022. Long COVID is technically known as COVID-19 Post-Acute Sequelae (PASC).
Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) recently completed Canada’s biggest legal natural psilocybin harvest. Health Canada has granted the company permission to produce and supply natural, EU-GMP quality psilocybin and other hallucinogenic chemicals, most notably MDMA, and functional mushrooms aimed at the health and wellness industries.
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