- Optimi Health (OPTI) completes pre-clinical trial application meeting
- The administrators of the IMPACT Clinical Trials Accelerator at the University of Calgary engaged with Health Canada representatives on June 9, 2021, to discuss Optimi’s preliminary information package
- This includes investigational product chemical constituents, genotype, and formulation
- Optimi will retain 100 per cent ownership of the resulting all-natural psilocybin product
- Optimi Health Corp. (OPTI) is flat on the day, trading at C$0.70 at 11:24 am ET
Optimi Health Corp. (OPTI) has received Health Canada approval to proceed with a formal submission to initiate their previously proposed phase 1 study.
The administrators of the IMPACT Clinical Trials Accelerator at the University of Calgary engaged with Health Canada representatives on June 9, 2021, to discuss Optimi’s preliminary information package submitted as part of a pre-clinical trial application (CTA).
This includes investigational product chemical constituents, genotype, and formulation as well as procedures and processes to produce a consistent dosage from Psilocybe mushrooms.
Michelle Nelson, Ph.D., CAPM, Senior Manager, Business Development and Strategic Planning for the IMPACT program notes, “We have been given the green light to submit the formal application for the proposed phase I dosing study from Health Canada and are on track to initiate the trial in Q3 of this year.”
“Health Canada indicated they have no concerns over the plan as presented, and they’ve clarified that the next step is now to submit the formal application to receive approval to move ahead with a phase I study,” concluded Nelson.
Concurrent efforts in recent weeks include cultivation, research, formulation development, and ongoing validation studies to produce the investigational psilocybin extract proposed for the phase I study.
These efforts are being undertaken at the Health Canada-licensed Numinus lab in British Columbia, Canada.
Insofar as the development work will be undertaken at the Numinus facility, Optimi will retain 100 per cent ownership of the resulting all-natural psilocybin product and full intellectual property rights to its use.
Optimi Chairman of the Board JJ Wilson states,
“We aim to enter a growing marketplace where the need is increasingly pronounced because of the current pandemic. Thousands, perhaps tens of thousands of individuals stand to benefit from the efforts we are undertaking.”
Optimi is developing a mushroom brand that focuses on the health and wellness markets.
Optimi Health Corp. (OPTI) is flat on the day, trading at C$0.70 at 11:24 am ET.
