Optimi Health, ATMA Sign LOI for Phase II MDD Trial Protocols

May 22, 2024 -- Optimi Health Corp., a prominent Health Canada licensed psychedelics pharmaceutical manufacturer, has signed a Letter of Intent (LOI) with ATMA Journey Centers (ATMA). ATMA is a trailblazing Canadian company dedicated to developing innovative solutions for psychedelic-assisted therapy. The LOI specifies that Optimi will supply its GMP natural psilocybin extract for ATMA's Phase II Psilocybin Clinical Trial, which will include both Group and Individual Set and Setting protocols.

Within the next 45 days, the two parties aim to finalize a definitive agreement. Under this agreement, Optimi will be the exclusive supplier of GMP psilocybin drug candidates for ATMA, with future net sales revenue being shared. Moreover, Optimi will handle any necessary product development to prepare for ATMA's Phase III clinical trial slated for 2025.

ATMA will have commercial access to Optimi's natural psilocybin drug candidate for its group administration protocol. This collaboration covers crucial regions like Canada, the United States, the United Kingdom, and the European Union, aiding in treating Major Depressive Disorder (MDD) within ATMA's Group therapy framework. The combined supply agreement and group administration protocol will enable ATMA to offer the most cost-effective and accessible psilocybin-assisted therapy across its extensive network of clinics and practitioners in North America, known as the ATMA CENA network.

Both Optimi CEO Bill Ciprick and ATMA CEO Vu Tran believe that the synergy between Optimi's scalable GMP manufacturing capabilities and ATMA's group therapy protocol will produce cost-effective, high-quality psilocybin, enhancing the generation of robust clinical data in both Group and individual settings.

"This strategic partnership allows ATMA to progress clinical protocols towards approval using trial data, avoiding significant overhead costs in drug development, while Optimi's Health Canada licensed GMP psilocybin ensures trial patients have access to high-quality products under stringent regulatory controls," stated Ciprick and Tran. "This collaboration highlights ATMA's dedication to therapeutic advancement and showcases Optimi's supply advantage, placing the alliance at the forefront of psychedelic therapy innovation."

By 2024 and 2025, Optimi's botanical psilocybin drug candidate is expected to complete Phase II and Phase III clinical trials, making the company one of the few GMP psychedelics pharmaceutical manufacturers worldwide to reach this milestone. Ciprick and Tran noted that the shared objective of this agreement is to achieve breakthrough therapy status post-Phase II, in line with the accomplishments of industry leaders such as Compass Pathways, Mind Med, and MAPS (now Lykos Therapeutics).

The potential psychological benefits linked with group therapy are widely recognized within the psychedelic industry. However, it's understood that the current legalization pathway for psychedelic-assisted therapy could result in unequal access due to financial barriers. A research paper titled "Group psychedelic therapy: empirical estimates of cost-savings and improved access" examined the outcomes of group and individual therapy, along with clinician time, costs, and patient accessibility. The findings indicated that group therapy significantly reduced the need for full-time equivalent clinicians for psilocybin-MDD therapy, leading to substantial projected savings and improved accessibility and affordability. Therefore, adopting group therapy protocols not only boosts efficiency but also reduces costs and addresses the shortage of trained clinicians, thereby enhancing access to psychedelic-assisted therapies.

"We recognize the importance of cost management in ensuring the accessibility of psychedelic-assisted therapy (PAT)," expressed Vu Tran, CEO of ATMA. He is confident that the supply agreement with Optimi, together with ATMA's group administration protocol, will propel the advancement of PAT in a fair and affordable manner.

Optimi CEO Bill Ciprick added, "Optimi is dedicated to advancing PAT by leveraging our expertise in cultivating and analyzing GMP psychedelic drug candidates at scale. Our agreement with ATMA aligns perfectly with our goal of providing the most cost-effective solutions for PAT clinical trials. Together, we are driving the advancement of PAT in a way that is both equitable and affordable, ensuring accessibility for all who can benefit."

Optimi Health Corp. is a leading Health Canada licensed psychedelics pharmaceutical manufacturer, focusing on natural psilocybin and MDMA, as well as functional mushrooms targeting the health and wellness markets. Built to produce scalable psychedelic formulations for transformative human experiences, the company aims to be a trusted, compassionate supplier of safe drug candidates globally. Optimi's products are cultivated and manufactured at its two facilities, totaling 20,000 square feet, in Princeton, British Columbia.

ATMA is pioneering a healthcare practitioner-centered business model for the psychedelic industry. By offering education, training, clinical trials leading to IP protocols, support services, and developing a network of clinics, ATMA is building and supporting a vast community of psychedelic practitioners. This approach aims to enhance access to psychedelic-assisted therapy, thereby improving access for many.

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