Posted on

Taking the trip out of psilocybin

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.

Posted on

Nova Mentis receives approval for autism clinical study

Nova Mentis Autism Clinical Study Approved by Canadian Institutional Review Board

Are psychedelics the future of autism treatment? Nova Mentis Life Sciences Corp. (NOVA) received Canadian approval for a new study on autism, which will be the first step in bringing psilocybin treatment to autistic patients. Researchers will observe 200 patients with autism spectrum disorder (ASD) or fragile x syndrome (FXS) to establish baseline biomarkers that can be used to measure psilocybin treatment responses in a later study. NOVA will monitor the gut microbiome, immune response, and serotonin activity in patients, as these factors influence behavioural symptoms.

PDF of article