Author Archives: Patricia Inacio PhD

Gaboxadol in Combo Therapy for Fragile X Worth Pursuing: Healx

Healx has entered into an exclusive licensing agreement with Ovid Therapeutics to develop and commercialize gaboxadol in a potential combination treatment for fragile X syndrome and other disorders. The announcement follows Ovid’s decision to discontinue the development of gaboxadol (previously called OV101), despite it being deemed safe and well-tolerated in…

Quris Planning AI-powered Clinical Trial in 2022

A candidate therapy for fragile X syndrome — developed using Quris’ bio-artificial intelligence clinical prediction platform — will enter clinical trials in 2022, the company announced. Quris is using the power of artificial intelligence (AI)  combined with a “patients-on-a-chip” platform to predict the safety and potential effectiveness of therapeutic…

Nova Seeks Orphan Drug Status in US for Psilocybin, Hallucinogenic Therapy

Nova Mentis has filed an application for orphan drug designation with the U.S. Food and Drug Administration (FDA) for psilocybin, its investigational psychedelic therapy for fragile X syndrome. Recently, psilocybin received orphan drug designation from the European Medicines Agency (EMA), which offers financial incentives for potential rare disease treatments. Nova also…

FDA OKs Phase 2 Trial Design for Xanamem

The U.S. Food and Drug Administration (FDA) has given positive feedback to Actinogen’s pre-investigational new drug (pre-IND) submission regarding Xanamem, its experimental oral therapy for fragile X syndrome. In a written response following a pre-IND meeting with Actinogen, the FDA agreed the data gathered and the proposed trial design…

Study Will Probe Gut Microbiome in ASD, Fragile X

Nova Mentis is launching a clinical study in the U.S. to assess the diversity of gut microbiome — the community of microbes living in the gut — in people with autism spectrum disorder (ASD), including fragile X syndrome, the company announced. The research is intended to help…