Numinus Wellness (NUMI.V) and Optimi Health (OPTI.C) announced they have submitted a pre-clinical trial application to Health Canada.
The application was submitted through Impact Clinical Trials Accelerator at the University of Calgary. The information package includes the investigational product’s chemical constituents, genotype, and formulation as well as procedures to produce a consistent dosage from Psilocybe mushrooms.
Numinus is anticipating regulatory approval and feedback from Health Canada, and will use the candidate mushroom clone to develop a uniform all-natural psilocybin capsule for use in Optimi’s human clinical trials. The first use will be for a dosing study, and then they plan to expand into trials for a variety of human health conditions.
During the application process, Numinus will continue their cultivation, research, formulation and continuous validation studies to produce the investigational psilocybin extract at their Health Canada-licensed lab in British Columbia.
“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,” stated Sharan Sidhu, Science Officer and General Manager of Numinus Bioscience. “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’s goal is to build a vertically integrated, cultivator to consumer functional mushroom operation. They see functional mushrooms as a growing part of the global nutraceutical market. The functional mushroom is growing at a rate of 6% annually, and they expect it to reach $34 billion globally. They also believe mushroom and nutraceutical blends are the most profitable path forward.
By partnering with Numinus, they increase their access to existing lab equipment and scientific expertise which can help them receive approval from Health Canada. Crucially, Optimi maintains 100% ownership of the resulting all-natural psilocybin capsule being tested, as well as full intellectual property rights to its use.
This partnership allows Optimi to gain valuable data on their product and move the Health Canada approval process forward without surrendering any ownership of their eventual product before they complete the development of their cultivator to consumer capabilities. This is crucial for their business plan, which is targeting full vertical integration, allowing them to maintain maximum profitability on the product once it hits the market.
Optimi Chairman of the Board JJ Wilson comments, “This is another important step for our commitment to 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. By using natural products, we seek to unlock the full value potential in this sector. 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.”
Following the news, Optimi’s share price declined two cents and is currently at $0.70.
Numinus shares, on the other hand, are up two cents and are currently trading at $0.90.