Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) is submitting a clinical trial application (CTA) for a Phase I combinatorial study that will document the safety of Optimi’s natural psilocybin standardized extract and proprietary 3,4-methylenedioxy-
The single site, double-blind, five arm study will include 25 participants randomized into one of five groups to undergo a supervised experimental session. Participants will receive either 25mg of natural psilocybin and a placebo, 125mg of MDMA and a placebo, or 25mg of natural psilocybin in combination with MDMA (50mg, 80mg, or 125mg).
“With an estimated 25,000 to 100,000 therapists needed to support the millions of people suffering with post-traumatic stress disorders, Optimi feels strongly that clinical research undertaken at this stage by GMP cultivators and formulators in partnership with mental health training services such as ATMA should be geared toward meeting this immediate need,” said CEO Bill Ciprick. “Therapists provided experiential training with both substances will in turn be able to provide greater value and higher standards of care to patients undergoing these treatments.”
Earlier this week, Optimi announced the successful completion of its novel MDMA drug candidate, OPTI-MHCL, which was tested for purity on-site with a result of >99% over multiple consistent batches by Chief Science Officer, Justin Kirkland. Both drug candidates are scheduled to be administered in the clinical trial and will be manufactured in-house at Optimi’s 20,000-square-foot facilities in Princeton, British Columbia. The company believes that the work it did in 2022 will have an impact this year.
The company said in a statement that the investigator-initiated double-blind placebo-controlled study is being conducted through ATMA Journey Centers in Calgary, Alberta, and will be the first of its kind to directly compare the acute effects of these substances within the same clinical study. ATMA is currently the only Canadian organization that has completed a successful Phase I safety trial with natural psilocybin in healthy therapists.
Optimi said that the primary objective of the trial is to demonstrate the safety and tolerability of the combinatory use of natural psilocybin and MDMA in healthy participants, broadly validating its offering and, in later stages, indicating the suitability for use of these substances, combined and separately, in experiential training by psychedelic therapy practitioners.
“This is about helping people heal. Optimi Health receives emails from patients and physicians on an almost daily basis, searching for our help in obtaining some level of mental health support and asking when these modalities might be available to them,” said Ciprick. “They are entrusting us to deliver because they still have hope, and that is why we have set an ambitious course of action in 2023 that will help therapists complete their training in time to bring them the support they need. This trial offers a tangible step forward in that essential process, for which the endpoint is providing relief for countless sufferers.”