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Be the first with the news that moves the market- Optimi Health (OPTI) has submitted its clinical trial application (CTA) for a Phase I combinatorial study
- The study will document the safety of Optimi’s proprietary 3,4-methylenedioxy-methamphetamine (MDMA) drug candidate in healthy therapist subjects
- The primary objective of the trial is to demonstrate the safety and tolerability of the combined use of Psilocybin and MDMA drug candidates In healthy therapists
- Optimi Health Corp. is a drug manufacturer and formulator licensed by Health Canada
- Optimi Health Corp. (OPTI) is up 4 per cent on the day, trading at C$0.26 per share at 12 pm ET
Optimi Health (OPTI) has submitted its clinical trial application (CTA) for a Phase I combinatorial study.
The study will document the safety of Optimi’s natural psilocybin standardized extract and proprietary 3,4-methylenedioxy-methamphetamine (MDMA) drug candidate in healthy therapist subjects.
Optimi previously 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, B.C.
The investigator-initiated double-blind placebo-controlled study is being conducted through ATMA Journey Centers in Calgary, Alberta. It will be the first of its kind to directly compare the acute effects of these substances within the same clinical study.
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 Optimi’s offering and, in later stages, indicating the suitability for use of these substances, combined and separately, in experiential training by psychedelic therapy practitioners.
“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. Therapists will be able to provide greater value and higher standards of care to patients undergoing these treatments,” said Optimi CEO Bill Ciprick.
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).
The company will collect data, including blood pressure, temperature, heart rate, and ECG readings. It will assess both safety and additional markers, such as the mystical experience questionnaire in the healthy therapist subjects that have consumed Optimi’s proprietary MDMA formulation and natural GMP psilocybin. Further, the Company is exploring the potential inclusion of novel, non-invasive, whole-body electrophysiological technology that would provide real-time functional analyses of 24 organs and glands on each participant.
Optimi has set the important goal of using its operational strength and end-to-end capabilities to tackle the global mental health crisis in 2023 and beyond.
“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.”
Optimi Health products are still being investigated through a clinically validated development program for the purpose of applying for market authorization. Though the Company has conducted rigorous internal analysis, the safety and efficacy of our products are still being formally established.
Optimi Health Corp. is a drug manufacturer and formulator licensed by Health Canada to produce and supply natural, GMP-grade psilocybin, synthetic psychedelic substances, and functional mushrooms that focus on the health and wellness markets.
Optimi Health Corp. (OPTI) is up 4 per cent on the day, trading at C$0.26 per share at 12 pm ET.
