Nova Mentis Life Sciences Corp (OTCMKTS: NMLSF) has announced that the European Medicines Agency (EMA) has granted it an Orphan Drug Designations for its novel psilocybin drug for fragile X syndrome (FXS) treatment. FXS is the main genetic cause of autism spectrum disorder (ASD) related symptoms.
Nova Mentis psilocybin drug granted orphan drug status by EMA
The orphan drug designation makes the drug eligible for ten years of market exclusivity, access to grants, scientific advice, and procedural and administrative assistance, access to marketing authorization via a single application, and reduced protocol assistance fees.
CEO & President Will Rascal said, “Orphan Drug designation of our proprietary psilocybin formulation in Europe is a significant milestone on the pathway to drug approval,” says Will Rascan, NOVA’s CEO & President. “This achievement has the potential to rapidly advance our company’s clinical program in Europe with the goal of approval of psilocybin in the treatment of FXS, a major unmet medical need. As a result, Nova intends to move expeditiously to begin a phase 2 study with psilocybin in FXS.”
FXS has no available treatment currently
FXS has no recognized preventative or treatment strategies currently. Available therapies, which include behavioral and pharmaceutical interventions, are a patchwork of ineffective and hazardous treatments. Psilocybin has the ability to affect the immune system and brain signaling pathways, as well as influence cognition and behavior. Similarly, psilocybin is non-toxic and unlikely to cause negative side effects in humans.
Nova Mentis Scientific Advisory Board Dr. Marvin Hausman commented, “Our proprietary psilocybin drug is being proposed as a novel, first-in-class treatment for fragile X. We have achieved several drug development breakthroughs this year, including a significant therapeutic effect in validated preclinical models of ASD and FXS, identification of an effective dose and no observed psilocybin toxicity. We look forward to working closely with EMA to advance our efforts to receive European regulatory marketing approval for our leading psilocybin drug candidate.”
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