Novel psychedelic drugs have continuously proven their worth in clinical trials. Just recently, one company revealed that it was in the process of finalizing its Phase 1 first-in-human clinical trial plan for its lead psychedelic drug for the treatment of major depressive disorder after receiving feedback from the UK Medicines and Healthcare products Regulatory Agency (MHRA). According to a recent report from Data Bridge Market Research, the psychedelic drug market is expected to grow from $2.99 billion in 2021 to $8 billion by 2029, representing a CAGR of about 13.3%. That means that psychedelic companies like Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF), Atai Life Sciences (NASDAQ:ATAI), Mind Medicine Inc. (NASDAQ:MNMD) (NEO:MMED), COMPASS Pathways plc (NASDAQ:CMPS), and Cybin Inc. (NEO:CYBN) (NYSEAMERICAN:CYBN) that already have clinical trials in progress are uniquely positioned to take a huge chunk of the market due to their first mover advantage.
Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is a Canadian-based psychedelic drug developer backed by billionaire financier and Lululemon founder Chip Wilson. The company is licensed by Health Canada to produce and supply natural EU-GMP-grade psilocybin and other psychedelic substances, most notably, MDMA.
On October 11, Optimi Health announced that it has closed a non-brokered private placement of 5,692,308 units at a price of $0.325 per unit for gross proceeds of $1.85 million with
Chip Wilson. Chip Wilson was the founder of Lululemon and is a well known Global wellness supporter and philanthropist.
“Our participation in the placement speaks to our belief that the Company can achieve its plan to be a world leader in psychedelic product development and global distribution,” said Wilson.
Optimi intends to use the proceeds to support its psychedelic product commercialization efforts, ongoing psilocybin and MDMA research and clinical trial initiatives, in-house drug development, as well as for general working capital.
Optimi also recently announced that, together with ATMA Journey Centers, it will be going ahead with a Phase I clinical trial application (CTA) to document the safety of Optimi’s natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.
Once approved by Health Canada, it would be the first clinical trial to evaluate both safety and additional markers, including the mystical experience questionnaire in healthy subjects that have consumed MDMA. The primary goal of the clinical trial is to acquire patient data for Optimi’s proprietary formulation using natural EU-GMP psilocybin and MDMA, including ECG readings, blood pressure, temperature and heart rate.
“The clinical validation of our products on healthy subjects brings us one step closer to commercialization,” said Optimi Health’s CEO Bill Ciprick. “Coming off the success of ATMA’s recently completed Phase I psilocybin trial and a No Objection Letter to conduct its N-500 Phase II psilocybin clinical trial on frontline healthcare professionals, we’re excited to officially begin the process.”
On September 30, Optimi announced that it had finalized a strategic private placement with Wilson Capital, the private equity division of Hold It All Inc. according to the company, the strategic cash investment will go towards supporting the company’s psychedelic product commercialization rollout, upcoming clinical trial initiatives for Psilocybin and MDMA, and in-house drug development.
Other Psychedelic Companies Advancing Clinical Trials
Atai Life Sciences (NASDAQ:ATAI), recently said that its Phase 1 study for EMP-01 had received regulatory and ethics approvals from Medsafe and HDEC to start patient enrollment. EMP-01 is an MDMA derivative designed to treat post-traumatic stress disorder (PTSD) and other indications. The Phase 1 trial is a randomized double-blind, placebo-controlled study that will assess the safety and tolerability of single ascending doses of EMP-01 in healthy participants. The trial will assess the usability and acceptability of the IDEA-1 app in delivering “set and setting” content to patients as they prepare for the administration of EMP-0.1. This study also includes a range of behavioural assessments that, together with the PK and safety readouts, will inform the design and doses tested in future Phase 2 clinical trials of EMP-01.
Mind Medicine Inc. (NASDAQ:MNMD) (NEO:MMED) has revealed that the first subject has been dosed in a Phase 1 investigator-initiated study led by Prof. Dr. Matthias Liechti at University Hospital Basel. The goal is to assess the effects of MDMA-like substances, including MDA, Lys-MDMA, and Lys-MDA, versus placebo in healthy participants. The clinical trial is a randomized, placebo-controlled, double-blinded, 5-period crossover study. The trial will enroll 24 healthy subjects who will receive MDMA (100mg), MDA (93.9mg), Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg), and placebo.
COMPASS Pathways plc. (NASDAQ:CMPS) announced it launched a multi-centre, double-blind, randomized controlled phase II clinical trial evaluating the efficacy of COMP360 psilocybin, administered with psychological support, in people with anorexia nervosa. This trial will compare the effects of 25 milligrams (mg) and 1 mg of COMP360 psilocybin, along with psychological support, in 60 participants suffering from anorexia nervosa, across four world-leading research institutes in the UK and US. In May, COMPASS announced positive early signals from an exploratory, open-label investigator-initiated study conducted by Dr. Walter Kaye, Professor of Psychiatry at the University of California San Diego School of Medicine
On August 30, Cybin Inc. (NEO:CYBN) (NYSEAMERICAN:CYBN) announced that its first two participants had begun dosing in its Phase 1/2a trial for evaluating CYB003 as a treatment of major depressive disorder (MDD). According to preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect. These preclinical data effectively showed that CYB003 could reduce the time and resource burden on patients, providers, and payers and had the potential to improve the scalability and accessibility of treatment. According to the company, the beginning of dosing in the first-in-human phase II trial is another significant milestone for Cybin, considering it reached the clinic in just under 18 months. The company’s goal remains to be a leader in creating the best psychedelic therapies for patients.
Apart from conducting clinical trials, Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is establishing itself in the space by recently completing the biggest legal psilocybin harvest in Canada’s history.
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