Optimi Health Corp. announced the signing of an international natural psilocybin supply agreement with New Zealand-Based Matai Medical Research Institute (Matai), on behalf of the Tu Wairua Project. This agreement marks Optimi's first supply deal to New Zealand, a significant milestone for the company's global expansion efforts.

Under the terms of the agreement, Optimi will provide Matai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract. Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance. This follows Optimi's recent announcement that three validation batches of its Natural Psilocybin extract had successfully undergone full release testing, resulting in the issuance of the Certificate of Analysis (COA).

In November 2023, the Tu Wairua project, a collaborative effort involving a diverse array of individuals, whanau (families), community groups, and institutions, convened at Rangiwaho Marae, a tribal meeting place in the Tairawhiti region of New Zealand. The project team has since designed a clinical trial protocol and securedethics and regulatory approval for its inaugural clinical study. Scheduled for mid-2024, the trial, titled "Pilot Study of Psilocybin Administration in Healthy volunteers within a Marae Setting," aims to evaluate the feasibility, acceptability, and safety of administering psychedelic-assisted therapy to Maori patients in a marae setting.

The insights gained from this trial will inform potential future controlled trials involving Maori patients with methamphetamine use disorder. Dr. Patrick McHugh, Community Liaison for Matai, confirms that the trial will centre on training local clinicians, rongoa (traditional Maori medicine) specialists and marae community members as kaitieki (guides) in psychedelic assisted therapy. Additionally, it will involve integrating the associated kawa and tikanga (cultural practices and protocols) into the therapeutic experience, making this the first trial of its kind in Aotearoa.

In New Zealand, any registered prescriber can apply through the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) for permission to administer an unapproved medicine. As the only fully equipped Canadian psychedelics pharmaceutical manufacturer, Optimi is well-positioned to meet large-scale demand for GMP psilocybin and MDMA drug products through its 10,000 sq ft cultivation and formulation facility.