Ovid Therapeutics: Positive Initial Data from Trial of Rare Epilepsies Med

Ovid Therapeutics Inc. (NASDAQ: OVID) today announced positive initial data from the ENDYMION trial, a Phase 2 open-label extension study of soticlestat (OV935/TAK935) in patients with rare developmental and epileptic encephalopathies (DEE). DEE is a heterogeneous group of rare highly-refractory epilepsy syndromes and encompasses Dravet syndrome, Lennox-Gastaut syndrome (LGS), and others. Soticlestat is a potent, highly-selective first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being investigated as a novel approach to treating adults and children with rare epilepsies in collaboration with Takeda Pharmaceutical Company Limited.

This initial data from the ENDYMION open-label extension trial is from patients who previously completed Ovid’s 12-week Phase 1b/2a clinical trial of soticlestat in adults with DEE. At 12 weeks, safety and tolerability observations with soticlestat in the ENDYMION study were consistent with the completed Phase 1b/2a clinical trial. Furthermore, longer-term data from ENDYMION out to 48 weeks suggest increased seizure reduction with prolonged treatment of soticlestat in this difficult-to-treat, adult patient population with various types of DEE. Median seizure frequency reductions were 84% following 25-36 weeks (n=6) and 90% following 37-48 weeks (n=4) of treatment. In addition, the longest seizure-free durations experienced by two different patients were 264 consecutive days and 150 consecutive days, respectively.

https://www.globenewswire.com/news-release/2019/09/23/1919034/0/en/Ovid-Therapeutics-Announces-Positive-Initial-Data-from-Ongoing-ENDYMION-Open-Label-Extension-Trial-of-Soticlestat-in-People-with-Rare-Epilepsies.html