Clinical-stage biopharmaceutical company Spinogenix Inc announced on Thursday that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization has approved 'codabakalner' as the non-proprietary name for the company's investigational therapy, SPG601.

Codabakalner is a first-in-class, oral investigational therapy being developed for the treatment of Fragile X syndrome (FXS), the leading inherited cause of intellectual disability and a known genetic cause of autism. The therapy is designed to positively modulate large-conductance calcium-activated potassium (BK) channels to correct specific synaptic dysfunctions underlying many of the core cognitive, behavioural, and sensory symptoms associated with FXS.

Spinogenix is a sponsor of this year's NFXF International Fragile X Conference in Louisville, KY, where chief medical advisor Craig Erickson, MD, will be presenting to share the new INN, codabakalner. Dr. Erickson will also share updates regarding CLARITY, Spinogenix's Phase 2b/3 trial evaluating the efficacy, safety, and tolerability of codabakalner in male patients with FXS.

Codabakalner has received both Orphan Drug designation and Fast Track designation from the FDA for FXS, as well as orphan medicinal product designation from the EMA. Plans for the CLARITY registrational-directed Phase 2b/3 trial have been agreed to with the FDA.