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Toronto's Center for Addiction and Mental Health (CAMH) just received the first-ever federal grant to study whether the active component of "magic" mushrooms can be used to treat depression. Researchers will explore whether the psychoactive effects are necessary to relieve treatment-resistant depression in adults. According to CAMH's lead investigator, clinical trials suggest that psilocybin, combined with psychotherapy, can produce "sustained antidepressant effects" in individuals living with severe depression. This news comes just days after a major scientific review found "no clear evidence" that low serotonin levels are responsible for depression, calling into question the efficacy of antidepressants. It's clear that alternative treatment options are necessary to combat depression and other mental illnesses, which is where companies developing psychedelic-based treatments like Optimi Health Corp. (OTCQX:OPTHF) (CSE:OPTI), ATAI Life Sciences (NASDAQ:ATAI), Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), Cybin Inc (NYSE:CYBN) (NEO:CYBN), and Enveric Biosciences (NASDAQ:ENVB) come in.
Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is a Canadian company aiming to be the number one trusted supplier of safe and natural EU-GMP psilocybin and functional mushrooms across the world. Optimi Health is developing a robust IP portfolio through its Health Canada Dealer's License and utilizing its 20,000 sq ft state-of-the-art production and research facilities to cultivate, test, and synthesize high-quality mushroom strains and psychedelic substances such as MDMA.
On July 14, Optimi Health announced that it has finalized a supply agreement with Bloom Psychedelic Therapy And Research Center, a Calgary-based provider of mental health services, including psychedelic-assisted therapies using ketamine treatments.
"Our Supply Agreement with Bloom solidifies another key relationship for Optimi," said Optimi Health CEO Bill Cirpick. "Their position as therapeutic practitioners, as well as their work in conducting the kind of clinical trials necessary to advance regulatory outcomes for psychedelic medicines, make them ideal partners in alignment with Optimi's strategic goals."
Optimi will give Bloom enough natural psilocybin biomass to start conducting its previously announced clinical trial in partnership with the IMPACT Clinical Trial Acceleration Program, located in the Alberta's Life Sciences Innovation Hub at the University of Calgary.
The proposed Phase I dosing study will aim to find the optimal microdose or low dose of psilocybin that provides general improvements in mood, memory, sleep, and other measures of general well-being without any hallucinogenic effect.
On June 28, Optimi announced that it has entered into a supply agreement with SABI Mind, a Calgary-based group of clinics that offers psychedelic-assisted therapies.
The company will provide SABI Mind clinical staff with supplies of GMP psilocybin and 3,4-methylenedioxymethamphetamine (MDMA), pending early approval of its previously announced license amendment, for the use by practitioners in psychedelic-assisted therapy. therapeutic protocols with patients approved through Health Canada's Special Access Program, clinical trials and academic studies.
"This agreement is an important step forward for both parties," Optimi Health CEO Bill Ciprick said. "SABI Mind's initiation of this agreement demonstrates a commitment to safe supply for the development and implementation of therapeutic modalities using psilocybin and MDMA."
Clinical distribution is an important step in the growth of the Canadian psychedelic sector from a business operations perspective and as a medical option for those in need.
For more information about Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF), click here.
Psychedelics Companies Bolstering Teams and Advancing Studies
Meanwhile, other companies in the psychedelic space are advancing studies and bolstering their leadership teams in order to meet the growing need for alternative treatments for mental illness.
On June 29, Kures Therapeutics, Inc, an Atai Life Sciences (NASDAQ: ATAI) company, announced the appointment of Chad E. Beyer, PhD. as its new Chief Executive Officer. Dr. Beyer has over 25 years of experience in the discovery, research and translational development of drugs that treat central nervous system and neurological disorders and is currently Senior VP of Research and Development at Promentis Pharmaceuticals, Inc. Atai Life Sciences also recently appointed Stephen Bardin as its Chief Financial Officer, starting in Q3 2022. Bardin serves as Senior VP of Finance and Operations at BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company with a wide portfolio of development programs. During his last few years at BridgeBio, he oversaw a wide range of financial activities and helped raise more than $2 billion through various financing transactions.
Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, announced on May 23 the topline results of the Phase 1 placebo-controlled trial of its opioid withdrawal treatment MM-110 in 108 healthy volunteers. The results showed favorable safety and tolerability, support the advancement of MM-110, and guided the dose, timing, and design of Phase 2a in people undergoing supervised opioid withdrawal. MindMed also recently bolstered its team with the appointment of Schond L. Greenway as CFO. Greenway brings over 20 years of experience in investment banking, corporate finance and advisory, and investment analysis in the life sciences industry.
On July 12, Cybin Inc (NYSE:CYBN) (NEO:CYBN) announced that enrollment has begun in a Phase 1/2a clinical trial of CYB003, the first novel psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (MDD). Cybin received Investigational New Drug authorization from the US Food and Drug Administration (FDA) for the Phase 1/2a trial in late June, marking the industry's first new psilocybin analog to enter. in clinical development. On July 11, Cybin announced that its wholly-owned subsidiary Cybin IRL Limited has completed the acquisition of a Phase 1 study of N,N-dimethyltryptamine (DMT) from Entheon Biomedical Corp. This DMT study, the largest to date, is expected to accelerate the clinical development pathway of CYB004, Cybin's proprietary deuterated DMT molecule for the potential treatment of anxiety disorders, by approximately nine months.
On July 26, Enveric Biosciences (NASDAQ:ENVB) announced that it had closed its previously announced registered direct and private placement offerings, which were priced at a premium to market under Nasdaq rules. The purchase price for one common share (or one pre-funded warrant) and one preferred investment option to purchase one common share is $8.00. The preferred investment options have an exercise price of $7.78 per share. The gross proceeds were approximately $8 million, which the company intends to use for working capital and general corporate purposes. Enveric Biosciences also recently appointed three new independent directors, Michael D. Webb, President and CEO of CXL Ophthalmics, Bevin O'Neil, Chief Strategy Officer of ECRI, and Frank Pasqualone, recently retired Chief Commercial Officer of Theravance, to its board of directors.
With a vertically integrated approach, Optimi Health Corp. is cultivating, extracting, processing and distributing high-quality functional and psychedelic mushroom products at its two facilities totaling 20,000 square feet in Princeton, British Columbia.
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