Optimi Health (OPTI.CN) said Wednesday it completed a production batch of 5-mg naturally derived psilocybin capsules.
The batch will supply the Phase 2 clinical trial evaluating psilocybin-assisted therapy in the treatment of major depressive disorder (MDD).
The Health Canada-approved trial consists of up to 200 participants, each receiving a single supervised dose. Patient dosing is expected to be completed by the end of next year. Data from the trial are intended to assess the safety and efficacy of psychedelic-assisted therapy.
The same batch will also supply Optimi's Australian customer base of licensed clinics, where 5-mg psilocybin capsules have been approved for prescribing to patients with treatment-resistant depression, a statement said.
"Since 2025, Optimi has supplied this psilocybin product commercially to licensed clinics in Australia, where it is prescribed and reimbursed for treatment-resistant depression," said Dane Stevens, chief executive officer. "We are excited to be collecting our own clinical data on the same product in our Health Canada-approved Phase 2 clinical trial for major depressive disorder."
Optimi Health shares were last seen up CA$0.03, to CA$7.08, on the Canadian Securities Exchange.
Price: $7.08, Change: $+0.03, Percent Change: +0.43%