Optimi Health Corp. and ATMA Journey Centers have confirmed their intent to proceed with a Phase I clinical trial application (CTA) that will document the safety of Optimi’s natural psilocybin biomass and MDMA in healthy patients.
The trial would assess both safety and additional markers, such as the mystical experience questionnaire in healthy subjects that have consumed MDMA.
The goal of the clinical trial is to acquire data including blood pressure, temperature, heart rate, and ECG readings. The psilocybin and MDMA products are being produced and tested in-house at Optimi’s 20,000 square foot facilities in Princeton, British Columbia.
Optimi CEO, Bill Ciprick, commented: “The clinical validation of our products on healthy subjects brings us one-step closer to commercialisation.
“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.
“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.”
ATMA is currently the only Canadian organisation that has received approval from Health Canada to conduct a Phase I safety trial with psilocybin in healthy therapists, which it completed last month.
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, in addition to documenting the healthcare providers’ firsthand evaluation of the potential effectiveness of psilocybin psychotherapy in the application.
ATMA CEO, David Harder, stated: “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.
“This is critical in providing a solid training program for therapists to prepare for the need that is already at our doorstep.”
Optimi’s plan for commercialisation involves the company being an active leader in meeting therapist demand for natural EU-GMP psilocybin and MDMA.
Both Ciprick and Harder have confirmed that Optimi will serve as the official clinical trial sponsor while ATMA delivers clinical research expertise through its medical advisory team led by Dr Michael Blough.
