Ovid Therapeutics announces additional data from STARS trial at AACAP
Ovid Therapeutics announced additional exploratory efficacy data and analyses from the company's Phase 2 STARS trial that further support the potential of OV101, a novel selective extrasynaptic GABAA receptor agonist that is being investigated to treat Angelman syndrome. Angelman syndrome is a life-long genetic disorder that is characterized by a variety of signs and symptoms, and for which there are no FDA-approved medicines or an established treatment paradigm. The additional efficacy data and analyses are being presented in a poster at the American Academy of Child and Adolescent Psychiatry, or AACAP, annual meeting. The additional data and analyses revealed changes in certain sleep parameters and motor domains in both adults and adolescents in the OV101 15 mg once-daily dose group as further described in the detailed STARS data summary below. Ovid believes these observed changes may have contributed to the statistically significant improvement observed in the clinician-rated clinical global impressions of improvement, or CGI-I, symptoms overall in the 15 mg once-daily OV101 dose group compared to placebo after 12 weeks of treatment, as reported in the topline data from the STARS trial on August 6. CGI-I is a global measure commonly used in clinical trials that allows the clinician to capture improvement in a constellation of clinical symptoms.