Ovid Therapeutics Announces Phase 3 NEPTUNE Clinical Trial of OV101 for the Treatment of Angelman Syndrome Did Not Meet Primary Endpoint
- OV101 program in Angelman syndrome to pause pending full analysis of NEPTUNE trial and discussions with FDA
- Pivotal studies of OV935 (soticlestat) in Dravet syndrome and Lennox-Gastaut syndrome expected to begin in the First Half of 2021
NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced topline results from the Company’s Phase 3 NEPTUNE clinical trial of OV101 (gaboxadol) for the treatment of Angelman syndrome.
NEPTUNE is a randomized, double-blind, placebo-controlled, Phase 3 study that enrolled and treated 97 patients diagnosed with Angelman syndrome, 4-12 years of age, and 7 patients diagnosed with Angelman syndrome ages 2-3 years for safety and pharmacokinetic evaluation only. The study was designed to assess the effects of treatment with OV101 (oral, once-daily dosing) versus placebo over 12 weeks. The sole primary endpoint was change in overall score on the Clinical Global Impression-Improvement-Angelman syndrome (CGI-I-AS) scale. Secondary endpoints included sleep, communication, motor function, socialization, daily living skills and behavior domains.
The primary endpoint of the NEPTUNE study was not achieved. Patients given OV101 showed a 0.7 point improvement in CGI-I-AS over baseline while placebo also showed a 0.8 point improvement in CGI-I-AS (p=NS). Secondary endpoints continue to be evaluated, although initial results show no difference between OV101 and placebo.
OV101 was well-tolerated, with no significant safety issues observed. Ovid plans to complete a full analysis of the results of the NEPTUNE study and discuss these results with the U.S. Food and Drug Administration (FDA) to determine next steps, if any, for the program. The Company will continue to offer study drug to patients enrolled in the open-label extension trial (ELARA) pending further analysis of the NEPTUNE study. The Company expects to report data from the ELARA study in the first quarter of 2021.
“We are deeply disappointed with the outcome of the NEPTUNE trial which did not achieve its primary endpoint,” said Jeremy Levin, DPhil, MB, BChir, Chairman and Chief Executive Officer of Ovid Therapeutics. “Other than the ongoing ELARA study, we plan to pause our OV101 program in Angelman syndrome pending a full understanding of this outcome and discussions with regulators and investigators.”
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