Optimi Health launches Phase 2 psilocybin-assisted therapy trial in major depressive disorder

• Optimi Health completed quality release of a single cGMP batch of 5 mg psilocybin capsules to supply a new Canadian Phase 2 trial.
• Study is a multisite, open-label trial in up to 200 people with major depressive disorder using one supervised dose.
• Results have not been presented; patient dosing is expected to finish by end-2027, with data intended to support future registration filings.
• The same batch will also supply Australian licensed clinics prescribing the product for treatment-resistant depression under the Authorised Prescriber Scheme.
• Optimi noted psilocybin-assisted therapy for major depressive disorder remains under investigation, with no Health Canada market authorization for its psilocybin products.

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