Ovid Therapeutics announces first patient randomized in Phase 3 NEPTUNE trial
Ovid Therapeutics announced that the first patient has been randomized in the company's single, pivotal Phase 3 NEPTUNE clinical trial evaluating OV101, a novel delta-selective GABAA receptor agonist, in Angelman syndrome. The company anticipates topline data from the trial to be available in mid-2020. NEPTUNE is a randomized, double-blind, placebo-controlled, Phase 3 clinical trial designed to assess the effects of treatment with OV101 versus placebo over 12 weeks. The trial will include approximately 60 pediatric patients ages 4 to 12 years diagnosed with Angelman syndrome. The sole primary endpoint will be change in overall score on the Clinical Global Impression-Improvement-Angelman syndrome scale. Secondary endpoints include sleep, communication, motor function, socialization, daily living skills and behavior domains. A limited number of children, ages 2 to 3 years, will also be enrolled in the study to evaluate OV101's pharmacokinetics along with safety and tolerability in this younger age group. Participants who complete the NEPTUNE trial will be eligible to roll over into the ongoing open-label extension trial should they choose to do so.