Nova Mentis receives Health Canada approval for psilocybin clinical trial CanadiansInvest
a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders announced that the company has received a No Objection Letter from Health Canada, allowing NOVA to proceed with the first-ever Phase II A clinical trial assessing repetitive, oral microdose psilocybin therapy for fragile X syndrome , the leading genetic cause of autism spectrum disorder .
The results of the 10-person, open-label study will be used to support NOVA’s drug development program under FDA Orphan Drug designation, which was received in late 2021. The trial will be led by KGK Science, NOVA’s clinical research organization partner, and recruiting efforts are expected to begin 1In September, NOVA completed production of pharmaceutical grade, cGMP synthetic psilocybin 1.
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