Nova Mentis Life Science Corp. (OTCQB:NMLSF), a biotech company focused on creating psilocybin-based therapeutics produced 1.5 mg psilocybin microdose capsules compliant with the chemistry, manufacturing and controls (CMC) published guidelines.
NOVA's new compounds would be used in support of a Phase II/a microdose psilocybin for Fragile X Syndrome (FXS) clinical trial application to Health Canada, done in partnership with clinical research organization partner KGK Science Inc.
The company is gathering the necessary documents for the agency to review, including a Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API), finished product batch manufacturing records and regulatory-compliant capsule dissolution parameters.
For NOVA's COO Jacqueline McConnell, the production of GMP-grade psilocybin microdose capsules constitutes "a major breakthrough" in the company's autism spectrum disorder (ASD) clinical research program.
Furthermore, McConnell expressed that, if approved, NOVA's new psilocybin capsules would be made available to doctors, clinics and pharma companies in Canada for potential therapeutic use in non-ASD clinical trials, such as diabetes, heart disease, epileptic conditions and PTSD.
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