OV101 Development Update: STARS Results and What’s Next
Dr. Amit Rakhit and Jeremy Levin from Ovid Therapeutics provided an update on the development of OV101 for the treatment of Angelman Syndrome. They discussed the results of the STARS clinical trial, which showed a statistically significant improvement in symptoms with the once-daily dose of OV101 compared to placebo. The primary endpoint of safety and tolerability was also achieved. Based on these results, Ovid Therapeutics plans to move forward with a Phase 3 trial in the four to 12-year-old age group. They also mentioned the ELARA study, an open-label extension study for participants of the STARS trial. Overall, the results are promising and suggest that OV101 could be one of the first treatments on the market for Angelman Syndrome.
Dr. Amit Rakhit and Jeremy Levin from Ovid Therapeutics provided an update on the development of OV101 for the treatment of Angelman Syndrome at the 2018 FAST Science Summit. They expressed their gratitude to the families and the FDA for their support and discussed the progress made in the STARS clinical trial.
Angelman Syndrome is a rare genetic disorder that affects motor function, behavior, sleep, and communication. Ovid Therapeutics conducted the STARS study, the first industry-sponsored clinical trial in Angelman Syndrome, to evaluate the safety and efficacy of OV101, a GABA-specific agonist.
STARS Study Design and Results
The STARS study included 88 participants aged 13 to 49 who were randomized into three groups: placebo, once-daily dose, and twice-daily dose. The primary endpoint was safety and tolerability, and secondary endpoints included measures of motor function, sleep, behavior, and communication.
The study showed that OV101 had a favorable safety and tolerability profile, with the most common adverse events being fever, rash, seizures, enuresis, myoclonus, otitis media, and viral infection. The once-daily dose of OV101 demonstrated a statistically significant improvement in the Clinical Global Impressions of Improvement (CGI-I) scale compared to placebo and the twice-daily dose.
Based on the positive results from the STARS study, Ovid Therapeutics plans to initiate a Phase 3 pivotal trial in the four to 12-year-old age group. The trial will be a two-arm, placebo-controlled study with the CGI-I as the primary endpoint. The company is also exploring opportunities to expand the study to other countries.
Additionally, Ovid Therapeutics is conducting the ELARA study, an open-label, once-daily dose study for participants who were part of the STARS study. The study will last for one year and will be conducted at multiple sites in the US.
Dr. Amit Rakhit and Jeremy Levin expressed their gratitude to the families and the FAST community for their support and collaboration. They emphasized the importance of partnerships in advancing the development of treatments for Angelman Syndrome and expressed their commitment to improving the lives of individuals with the condition.
- Title: OV101 Development Update: STARS Results and What’s Next
- Author(s): Amit Rakhit, Jeremy Levin
- Author(s)’ affiliation: Ovid Therapeutics
- Publication date: 2019-01-10
- Collection: 2018 FAST Science Summit