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Numinus Wellness and Optimi Health submit evidence package to Health Canada for all-natural psilocybin extract

Published: 11:00 11 May 2021 EDT

Numinus Wellness Inc. -
Studies are also ongoing at the Numinus lab in British Columbia

Numinus Wellness Inc (CVE:NUMI) said it has submitted a pre-clinical trial application to Health Canada for review of its all-natural psilocybin extract.

The Vancouver-based psychedelics company has partnered with Optimi Health Corp (CSE:OPTI) (OTCMKTS:OPTHF) to develop the psilocybin extract through Impact Clinical Trials Accelerator at the University of Calgary.

Studies are also ongoing at the Numinus lab in British Columbia.

READ: Numinus Wellness congratulates study team on announcement of results from Phase 3 randomized clinical trial of MDMA-assisted therapy for treatment of severe PTSD

Vancouver-based Numinus said that its submission to Health Canada included the investigational product's chemical constituents, genotype, and formulation as well as procedures and processes to produce a consistent dosage from Psilocybe mushrooms.

Once it receives feedback from the regulator, Numinus said it plans to use the candidate mushroom clone to develop a uniform all-natural psilocybin capsule for use in Optimi's human clinical trials, initially for a dosing study and then expanding into trials for a variety of human health conditions.

Optimi will retain 100% ownership of the resulting psilocybin capsule as well as full intellectual property rights.

"Numinus is pleased to partner with Optimi on this important work and provide the expertise, licensed facility and specialized equipment required to quickly develop, formulate and rigorously test products derived from natural Psilocybe sources and prepare them for Health Canada submissions and approvals," said Sharan Sidhu, science officer and general manager at Numinus in a statement.

"We look forward to continuing our work with Optimi to develop safe, standardized and reproducible products that provide meaningful and accurate clinical trial data."

Optimi chairman JJ Wilson called the submission "another important step” in the development of naturally sourced, evidence-based product formulations.

“As a cornerstone of our brand positioning, we believe that future consumer demand will be based on efficacy, cost, and source integrity. With the work we are embarking on today with the teams at Numinus and Impact, we are aiming for what we hope will become blockbuster candidates able to significantly transform the mental health therapeutic landscape, while remaining true to historic principles and natural organic origins."

Numinus is an integrated mental health company creating an ecosystem of health solutions to research, develop, and deliver safe, evidence-based, accessible psychedelic-assisted psychotherapy.

Contact Angela at angela@proactiveinvestors.com

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