- Optimi Health (OPTI) ATMA Journey Centers to proceed with Phase I natural psilocybin and MDMA clinical trial application to Health Canada
- This trial will document the safety of Optimi’s natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients
- Products are being produced and tested in-house at Optimi’s 20,000-square-foot facilities in Princeton, British Columbia
- Ciprick and Harder have confirmed that Optimi will serve as the official clinical trial sponsor
- Optimi Health (OPTI) is up 1.30 per cent,t rading at C$0.39 at 9:40 am EST
Optimi Health (OPTI) has confirmed its intent to proceed with a Phase I clinical trial application (CTA).
This trial will document the safety of Optimi’s natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.
Upon Health Canada approval, it would be the first trial to assess both safety and additional markers, such as the mystical experience questionnaire in healthy subjects that have consumed MDMA.
Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimi’s proprietary formulation using natural EU-GMP psilocybin and MDMA.
These products are being produced and tested in-house at Optimi’s 20,000-square-foot facilities in Princeton, British Columbia.
“The clinical validation of our products on healthy subjects brings us one step closer to commercialization,” said Ciprick.
“We [believe we] have an ethical responsibility to supply [people] with a life-changing product that is receiving considerable attention from regulatory bodies across the world,” added Ciprick.
Health Canada recently provided ATMA with a No Objection Letter to conduct an N-500 psilocybin Phase II clinical trial aimed at studying the potential relief of COVID-19-associated mental health concerns in frontline healthcare providers.
ATMA CEO, David Harder, recognizes the historical context of the CTA and says his team is looking to build on the success of his company’s leadership in therapist-centred and therapist-driven support and training.
“Securing a clinical trial using natural EU-GMP psilocybin and MDMA is key to the growth of training and providing for experiential learning with both of these molecules, and others, as they are developed by Optimi,” said Harder.
In August, psychedelic pioneer and industry stalwart Rick Doblin outlined his organization’s goal to train 25,000 therapists in MDMA-assisted therapy for PTSD before 2030.
Ciprick and Harder have confirmed that Optimi will serve as the official clinical trial sponsor. At the same time, ATMA delivers clinical research expertise through its medical advisory team led by Dr. Michael Blough.
Optimi Health is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets.
Optimi Health (OPTI) is up 1.30 per cent, trading at C$0.39 at 9:40 am EST.