Optimi Health and ATMA Journey Centers to Send a Clinical Trial Application to Health Canada for Phase I Natural Psilocybin and MDMA

Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF) is a Canadian company that makes natural, scalable, and easy-to-get psychedelic and functional mushrooms, as well as synthetic formulations, to help people have life-changing experiences. The company is on the list of approved suppliers for Health Canada’s Special Access Program (SAP), which gives doctors emergency access to Schedule 3 controlled substances like psilocybin.

Optimi Health (CSE:OPTI) (OTCQX:OPTHF) recently announced that the company intends to file a Phase I clinical trial application (CTA) in cooperation with ATMA Journey Centers to demonstrate the safety of Optimi‘s (CSE:OPTI) (OTCQX:OPTHF) natural psilocybin biomass and MDMA in healthy individuals.

It would be the first trial  evaluating the safety and other markers like the mystical experience survey in healthy participants who have ingested MDMA, assuming Health Canada’s permission.

According to Bill Ciprick, CEO of Optimi (CSE:OPTI) (OTCQX:OPTHF), the clinical trial’s objective is to collect data for the company’s patented formulation of natural EU-GMP psilocybin and MDMA tailored for commercialization, including blood pressure, temperature, heart rate, and ECG measurements.

“The clinical validation of our products on healthy subjects brings us closer to being a full-spectrum psychedelics firm,” said 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 almost can’t wait to get started,” he added. “For the thousands of trained professionals hoping to experience natural, EU-GMP psilocybin and MDMA, we believe we have an ethical obligation to supply them with a life-changing product that is receiving considerable attention from regulatory bodies across the world.” 

The Food and Drug Administration (FDA) designated MDMA-assisted psychotherapy for the treatment of PTSD as a Breakthrough Therapy in 2017.

To meet therapist demand for natural EU-GMP psilocybin and MDMA, Optimi‘s (CSE:OPTI) (OTCQX:OPTHF) commercialization strategy calls for the company to take the lead.

According to Ciprick and ATMA CEO, David Harder, Optimi Health (CSE:OPTI) (OTCQX:OPTHF) will be the official clinical trial sponsor, and Dr. Michael Blough’s medical advisory team at ATMA will provide clinical research experience. CTA protocol details will be made public once a no objection letter from Health Canada has been received.

The Optimi-ATMA partnership  will serve as the foundation for the further development of the company’s commercial pipeline and is intended to broaden the relationship that was first established with the signing of an initial psilocybin supply agreement in June 2022.

Optimi Health (CSE:OPTI) (OTCQX:OPTHF) intends to provide Health Canada with a Drug Master File in the upcoming months.

Optimi Health Completes Canada’s Largest Legal Natural Psilocybin Harvest

On September 8, Optimi Health (CSE:OPTI) (OTCQX:OPTHF) announced that the largest legal harvest of psilocybin in Canadian history was completed. Health Canada has given the company permission to make and sell natural psilocybin of EU-GMP grade, as well as other psychedelics like MDMA and functional mushrooms, with a focus on the health and wellness industries.

The company’s investment in environmental controls and cutting-edge facility cultivation processes resulted in a commercially harvested yield of more than 150 kg of Panaeolus cyanescens and Psilocybe cubensis.

All Optimi (CSE:OPTI) (OTCQX:OPTHF) mushroom products are made with material sourced from the company’s world-class psilocybin genebank. To ensure a sterile culture, they are grown in clean rooms adhering to EU-GMP rules and subjected to over 300 different analytical tests after harvest.

Following internal and third-party testing to Optimi’s (CSE:OPTI) (OTCQX:OPTHF) stringent product specifications and quality assurance standards, the company will begin distributing harvested quantities to meet supply agreements signed in recent months with various industry partners and accredited research entities worldwide.

To ensure minimal deterioration of natural psilocybin, all extra inventory from the harvest will be securely housed in Optimi‘s (CSE:OPTI) (OTCQX:OPTHF) Level 8 security vault.

Optimi Health (CSE:OPTI) (OTCQX:OPTHF) will also use the mushrooms to further enhance its on-site extraction procedures, with the proceeds going toward the finalization of its natural-origin psilocybin products this fall. The company is working on several forthcoming Phase 1 and 2 clinical trials to collect the necessary human safety data in healthy Canadians and patients with depression, anxiety, and PTSD.

Beyond encapsulated biomass, bringing a safe, federally licenced supply of psilocybin products to market is an essential aspect of the company’s global innovation plan.

For more information on Optimi Health Corp. (CSE:OPTI) (OTCQX:OPTHF), please visit this link.