Posted by Michael Wonder on 19 Dec 2017
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Angelman syndrome
19 December 2017 - Ovid Therapeutics today announced that the U.S. FDA has granted fast track designation to OV101 for the treatment of Angelman syndrome.
OV101 is a delta (δ)-selective GABAA receptor agonist that targets the disruption of tonic inhibition, a central physiological process of the brain that is thought to be the underlying cause of Angelman syndrome and other neurodevelopmental disorders.
Ovid is currently studying OV101 in its Phase 2 STARS clinical trial, a randomized, double-blind, placebo-controlled study investigating the safety and efficacy of OV101 in patients with Angelman syndrome. Upon successful completion of a Phase 1 pharmacokinetic (PK) and safety study showing that OV101 has a similar PK profile in adolescents as in adults, Ovid recently amended the STARS protocol to include patients aged 13 years and older.
