VANCOUVER, BC – April 2, 2024 – Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is pleased to announce that three validation batches of its Natural Psilocybin Extract have undergone full release testing and have been issued the Certificate of Analysis (COA) by a third-party, confirming compliance with Good Manufacturing Practice (GMP) specifications. Additionally, the Company has successfully completed the in-house encapsulation of psilocybin drug candidates in 5mg and 10mg dosage formats.
The third-party COA confirms critical information regarding potency, water content, microbial content, and heavy metal content, ensuring that the Natural Psilocybin Extract meets the predetermined specifications. The completion of both extract validation and finished product testing aligns with Optimi’s goal of advancing the drug candidate, marking significant progress toward its eventual release for human consumption.
“This is an exciting development for Optimi,” said CEO Bill Ciprick. “Obtaining successful results on the validation batches of psilocybin extract speaks to Optimi’s dedication to developing a repeatable, quality focused manufacturing process. This documentation provides important data and helps Optimi ensure patients receive an extract backed by evidence,” added Ciprick.
Ciprick also stated “We are able to create stable GMP inventory in-house and at scale which showcases Optimi’s unique position in the psychedelic supply chain. We’ve worked hard to secure the end-to-end production advantage.”
After six months of accelerated data collection, Optimi confirms that its Natural Psilocybin Extract maintained its original potency level without any degradation during stability testing. Furthermore, the Psilocybe cubensis mushrooms used in creating the extract were cultivated in-house under Good Agricultural Collection Practice (GACP) conditions, as highlighted in a recent video from earlier this year.
As the Company prepares to meet its Australian supply commitments with Mind Medicine Australia, Karina Lahnakoski, Optimi’s Director of Quality and Commercial Strategies, assures patients and therapists of the reliability and quality of Optimi’s drug candidates.
“Our drug development program for the Natural Psilocybin Extract has established a robust process which has been validated and confirmed through the COA testing and the stability program,” said Lahnakoski. “By conducting our program in accordance with guidelines established by organizations like the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the requirements of Good Manufacturing Practice (GMP), we further emphasize our commitment to patient safety and high-quality products.”
Dedicated to fostering collaborations and advancing the scientific understanding of the potential therapeutic benefits of psilocybin, Optimi welcomes inquiries from principal investigators and research groups interested in learning more about the Company’s validated GMP Natural Psilocybin Extract and other drug candidates.
For media inquiries, please contact Michael Kydd:
michaelk@optimihealth.ca
902.880.6121
For investor inquiries, please contact:
investors@optimihealth.ca
www.optimihealth.ca