Partnership to lead psilocybin therapy for Fragile X Syndrome (FXS), the leading genetic cause of Autism Spectrum Disorder (ASD) Health Canada in the form of no objection letter And we plan to proceed with the first-ever Phase 2a clinical trial of magic mushroom therapy for this condition.
mental health care company Wellbeing Digital Science Co., Ltd. KonevSubsidiary of KGK Science Co., Ltd. and based in Canada Nova Mentis Life Sciences, Inc. NMLSF submitted clinical trial application (CTA) was submitted to Canadian health authorities this November.
of The transaction between the companies includes long-term contract research organization KGK Sciences providing repetitive oral microdoses of proprietary psilocybin in the form of 1.5 mg capsules to 10 participants in FXS, which will begin in early 2023. This includes conducting a Phase 2 clinical trial of Nova Mentis evaluating the therapy.
“Over the past 25 years, our team at KGK has successfully assisted hundreds of companies with custom-designed clinical trials and proof-of-concept strategies that efficiently move their products to global markets. and Najla Guthrie, CEO of KGK, said:
“Nova Mentis is the first company in the world to conduct a human trial to test the efficacy of psilocybin in adults diagnosed with Fragile X. We would like to collect the clinical data necessary for research related to autism.
Nova Mentis’ goals include developing diagnostics and psilocybin-based therapies for neuroinflammatory diseases. It is the first biotechnology to achieve orphan drug designation in both the US and EU for the use of psilocybin in the treatment of FXS.
The results of the open-label study will be used to support Nova’s drug development program under FDA orphan drug designation, which is expected to be received in the second half of 2021.
This article originally appeared on Benzinga and is reprinted here with permission.