Optimi Health Corp. was incorporated under the British Columbia Business Corporations Act on May 27, 2020. The Company is a Canadian Good Manufacturing Practices (GMP) compliant pharmaceutical manufacturer licensed by Health Canada to handle controlled substances and conduct GMP production. The company focuses on controlled substances and its products include plant-derived MDMA and psilocybin. In addition, they hold licenses issued under the Canadian Narcotics Control Regulations that allow the possession, production, assembly, sale and delivery of psychedelic mushrooms and other psychedelic substances within the regulatory framework set by Health Canada. They also hold a precursor license under the Canadian Precursor Regulations allowing the import of 3,4-methylenedioxyphenylacetone for MDMA synthesis. 

Optimi Health Corp. plans to initiate a Phase 2 clinical trial evaluating psilocybin-assisted therapy for major depressive disorder. The trial, authorized by Health Canada, will enroll up to 200 participants across multiple sites in Canada and is expected to be completed by the end of 2027. The primary efficacy endpoint is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline. Optimi will supply its naturally derived psilocybin manufactured at its GMP facility.

Optimi Health

Optimi Health to Initiate Largest Psilocybin Depression Trial in Canada

Optimi Health plans to initiate a Phase 2 clinical trial in Canada to evaluate psilocybin-assisted therapy for major depressive disorder. The trial, expected to start in H1 2027 and complete by EOY 2027, will enroll up to 200 participants across multiple sites and assess the safety and efficacy of a single supervised dose of natural psilocybin. The trial will be one of the largest studies of naturally derived psilocybin to date.

Optimi Health Initiates 200-Participant MDD Psilocybin-Assisted Therapy Trial

Optimi Health Corp. plans to initiate a Phase 2 clinical trial in the first half of 2027, with dosing expected to be complete by the end of 2027. The trial will evaluate the safety and efficacy of a single supervised dose of natural psilocybin for major depressive disorder, enrolling up to 200 participants across multiple sites in Canada. The trial will use the Montgomery-Åsberg Depression Rating Scale as the primary efficacy endpoint.

Optimi Health to Initiate Phase 2 Trial for Psilocybin-Assisted Therapy in MDD

Optimi Health Corp has announced plans to initiate a clinical trial in the first half of 2027, with dosing expected to be completed by the end of the year, according to a recent company statement. The trial is part of the company’s ongoing research and development efforts in the healthcare sector. The timeline reflects a structured approach to advancing its pipeline, with specific milestones outlined for the upcoming year. Investors and stakeholders are advised to monitor the company’s progress as it moves through this phase of development. The company has not disclosed further details regarding the trial’s focus or expected outcomes at this time. This update is based on the latest available information provided by the company.<img src="https://cdn.ainvest.com/aigc/hxcmp/images/compress-1d1db362cecdb002.png" alt="Optimi Health Corp - Trial initiation planned for H1 2027, dosing to complete by end of 2027">

Optimi Health Corp - Trial initiation planned for H1 2027, dosing to complete by end of 2027

Optimi Health Corp. (NASDAQ: OPTH) has completed its first export of naturally derived psilocybin to the United Kingdom, supporting <a href="https://www.google.com/goto?url=CAESmgEB6zswFcvk0QOJusu6v-_rfQSvzyU2gqkbu5Ha0St6PF2x9WWfAM-mFZB4sFDCP4FIxrMVYnhCQKhOwJNz9ITr3b5HinijV0MzLFmbzxjaJjTeTrgNqQ11InvDIk_d2qSOyUlXW-r5YwIXU0aBt-Cp28wbXRsjw0KU-0xrIRmPb-2rlls5zNoJDexNmf4P8psxmFP0Y4ZIzuqO">a planned Phase 2 clinical trial</a> evaluating psilocybin-assisted therapy for major depressive disorder. The shipment includes psilocybin biomass and 5mg psilocybin capsules, manufactured at the company’s GMP-certified facility in Princeton, British Columbia. The capsules are formulated using <a href="https://www.google.com/goto?url=CAESmgEB6zswFcvk0QOJusu6v-_rfQSvzyU2gqkbu5Ha0St6PF2x9WWfAM-mFZB4sFDCP4FIxrMVYnhCQKhOwJNz9ITr3b5HinijV0MzLFmbzxjaJjTeTrgNqQ11InvDIk_d2qSOyUlXW-r5YwIXU0aBt-Cp28wbXRsjw0KU-0xrIRmPb-2rlls5zNoJDexNmf4P8psxmFP0Y4ZIzuqO">the same method as prescribed</a> to patients in Australia for treatment-resistant depression.The export was authorized by Health Canada and the UK Home Office, underscoring the regulatory framework supporting international clinical research involving psychedelic compounds. Optimi’s ability to produce both biomass and finished drug products under a single Health Canada Drug Establishment Licence positions the company as <a href="https://www.google.com/goto?url=CAESmgEB6zswFcvk0QOJusu6v-_rfQSvzyU2gqkbu5Ha0St6PF2x9WWfAM-mFZB4sFDCP4FIxrMVYnhCQKhOwJNz9ITr3b5HinijV0MzLFmbzxjaJjTeTrgNqQ11InvDIk_d2qSOyUlXW-r5YwIXU0aBt-Cp28wbXRsjw0KU-0xrIRmPb-2rlls5zNoJDexNmf4P8psxmFP0Y4ZIzuqO">a vertically integrated supplier</a> for psychedelic research.The company has not yet disclosed the trial partner or specific indication for the Phase 2 study but has emphasized <a href="https://www.google.com/goto?url=CAESmgEB6zswFcvk0QOJusu6v-_rfQSvzyU2gqkbu5Ha0St6PF2x9WWfAM-mFZB4sFDCP4FIxrMVYnhCQKhOwJNz9ITr3b5HinijV0MzLFmbzxjaJjTeTrgNqQ11InvDIk_d2qSOyUlXW-r5YwIXU0aBt-Cp28wbXRsjw0KU-0xrIRmPb-2rlls5zNoJDexNmf4P8psxmFP0Y4ZIzuqO">commitment to clinical research</a> and patient access to psychedelic-assisted therapies. Optimi’s operations include supplying psilocybin and MDMA drug products to regulated markets globally, with <a href="https://www.google.com/goto?url=CAESmgEB6zswFcvk0QOJusu6v-_rfQSvzyU2gqkbu5Ha0St6PF2x9WWfAM-mFZB4sFDCP4FIxrMVYnhCQKhOwJNz9ITr3b5HinijV0MzLFmbzxjaJjTeTrgNqQ11InvDIk_d2qSOyUlXW-r5YwIXU0aBt-Cp28wbXRsjw0KU-0xrIRmPb-2rlls5zNoJDexNmf4P8psxmFP0Y4ZIzuqO">products available in Australia</a> and accessible in Canada through the Special Access Program.<img src="https://cdn.ainvest.com/aigc/hxcmp/images/compress-1d1db341228db002.png" alt="Optimi Health to initiate phase 2 clinical trial evaluating psilocybin-assisted therapy for major depressive disorder">

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