Optimi Health releases 5 mg psilocybin batch for Canadian Phase 2 trial
The Health Canada-authorized depression study plans to enroll up to 200 people, while the batch also serves Australian clinics.
Theo Marchetti
Health Canada's previously authorized Phase 2 depression trial for up to 200 people gained a quality-released 5 mg psilocybin batch on Sept. 23. Optimi Health Corp. CNSXOPTI NASDAQOPTH shares traded at US$4.98 on Nasdaq at 11:40 a.m. EDT on Sept. 23.
Optimi said the capsules will supply its planned study and existing Australian clinic customers. The company disclosed neither the number of capsules in the batch nor new sales tied to it, leaving the effect on revenue unquantified.
The company said it manufactured, encapsulated and quality-tested the batch at its Princeton, B.C., facility under a Health Canada Drug Establishment Licence. The production release removes a supply step for the Canadian study but is not authorization to market psilocybin in Canada. Optimi says none of its psilocybin products has that authorization.
Optimi announced the trial on Sept. 10, saying it plans to begin in the first half of 2027 and finish dosing by the end of that year. Participants across several Canadian sites are to receive one supervised dose. The primary efficacy endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale, a clinician-rated measure of depression symptoms.
The Batch Will Also Supply Australian Clinics
The Sept. 23 release calls the study open label and says its findings will assess safety and efficacy. It does not describe a randomized or placebo comparison, and the company has reported no trial results. Interim readouts are planned, while full topline results are to follow dosing and follow-up; Optimi gave no date for either release.
The batch also goes to Australian clinics already supplied by Optimi. The company said its 5 mg capsules are prescribed there for treatment-resistant depression, a narrower condition than the major depressive disorder being studied in Canada. Optimi did not disclose Australian patient numbers, orders or a contract value in the Sept. 23 announcement.
Australia's Therapeutic Goods Administration has permitted authorized psychiatrists to prescribe psilocybin for treatment-resistant depression since July 1, 2023. Its Authorised Prescriber scheme requires ethics committee approval before a psychiatrist receives permission from the regulator. That route allows controlled treatment outside a clinical trial; it is separate from Canadian market authorization.
"Because we manufacture, encapsulate and release-test within our own licensed facility, the trial product and the commercial product are the same formulation from the same batch, and the Chemistry, Manufacturing and Controls file that supports registration is already ours."
Optimi chief executive Dane Stevens said that in the Sept. 23 release. His point about a common formulation is a manufacturing claim, while the Canadian study is still needed to test clinical outcomes.
Compass Is Further Along in Depression Trials
Compass Pathways plc NASDAQCMPS reported 52-week Phase 3 data on Sept. 9 for COMP360, its synthetic psilocybin formulation in treatment-resistant depression. Its U.S. COMP005 study enrolled 258 participants and included a randomized, blinded comparison before an open-label extension. Optimi's planned Canadian study uses naturally derived psilocybin for major depressive disorder and has yet to start, so the two programs are at different stages and study different patient groups.
Read more: FDA psychedelics hearing draws little pushback on future therapeutic use
Optimi plans to start the Canadian Phase 2 trial in the first half of 2027 and complete dosing by the end of 2027. That schedule, rather than the batch release, sets the next dated test of whether its manufacturing capacity can support its own clinical program.
