Nova Mentis Files Fragile X Orphan Drug Designation with European Medicines Agency
Fragile x syndrome (FXS) is the leading genetic cause of autism spectrum disorder (ASD) symptoms, yet there is currently no approved prevention or treatment options. Nova Mentis (NOVA) is working to fill this gap with a non-psychedelic psilocybin-based drug.
The company announced that its proprietary psilocybin drug, NM1010, was able to improve cognition without a creating psychedelic effect in a preclinical model of FXS. In tests on animals, the drug showed improvements in inflammatory biomarkers that may be linked to the ASD disease process.
The company has filed for orphan drug designation with the European Medicines Agency (EMA), a status that gives companies exclusive rights and tax credits to incentive the development of treatments for diseases affecting ≤ 5 in 10,000 people.