Mr. Will Rascan reports
NOVA MENTIS PSILOCYBIN MICRODOSE CAPSULE FORMULATION TO BE SUBMITTED IN HEALTH CANADA PHASE 2A CLINICAL TRIAL APPLICATION
Nova Mentis Life Science Corp. has produced 1.5-milligram psilocybin microdose capsules. These capsules were produced according to defined manufacturing processes and product specifications as outlined in chemistry, manufacturing and controls (CMC) published guidelines.
"Nova has accomplished a major breakthrough in its autism spectrum disorder (ASD) clinical research program with the production of GMP-grade [good manufacturing practice] psilocybin microdose capsules," stated Jacqueline McConnell, Nova's chief operating officer. "Nova is also excited to initiate the availability of the 1.5-milligram psilocybin capsules to doctors, clinics and pharmaceutical companies in Canada for its potential therapeutic use in non-ASD clinical trials, including, but not limited to, diabetes, heart disease, epileptic conditions and posttraumatic stress disorder (PTSD). Nova and KGK Science Inc. (KGK) are available to assist in the creation and submission of future clinical trial applications to Health Canada for review."
Nova has in hand a complete CMC package to be used in support of a phase 2A microdose psilocybin fragile X syndrome (FXS) clinical trial application. The package to be submitted to Health Canada for review includes:
- Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API);
- Finished product batch manufacturing records that confirm final capsule batch has been produced;
- Psilocybin capsule dissolution parameters that meet regulatory requirements.
Nova and KGK, its clinical research organization (CRO) partner, are currently finalizing the clinical trial application that will be submitted to Health Canada for approval of a phase 2A study evaluating psilocybin microdose therapy for FXS, the leading genetic cause of ASD.
Further, the company has granted an aggregate of 4.6 million incentive stock options to members of its board, management team and consultants of the company. The options are exercisable at a price of five cents per share for a period of five years. The options have been granted under and are governed by the terms of the company's incentive stock option plan.
About Nova Mentis Life Science Corp.
Nova Mentis Life Science is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of fragile X syndrome.
Nova's goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.
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