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Ovid Therapeutics Announces Positive Initial Data from Ongoing ENDYMION Open-Label Extension Trial of Soticlestat in People with Rare Epilepsies
Sustained and Progressively-Improving Median Seizure Frequency Reduction Reaching 84-90% with Prolonged Treatment of Soticlestat in this Difficult-to-Treat
About this update from Ovid Therapeutics Inc.
[{"type":"text","content":"Sustained and Progressively-Improving Median Seizure Frequency Reduction Reaching 84-90% with Prolonged Treatment of Soticlestat in this Difficult-to-Treat Patient Population\n Soticlestat Continues to Advance in Rare Epilepsies; Initial Data from Phase 2 ARCADE Trial Anticipated in Q1 2020 and Data from ELEKTRA Trial Now Anticipated in 2H 2020 Due to Robust Enrollment Ovid to Host Conference Call Today at 8:00 a.m. EDT NEW YORK, Sept. 23, 2019 (GLOBE NEWSWIRE) -- 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. “While this first data cut includes a small number of patients, these initial results from ENDYMION reaffirm the potential of soticlestat to provide a tangible and durable clinical benefit for patients with DEE, a group of difficult-to-treat seizure disorders with limited therapeutic options,” said Amit Rakhit, MD, MBA, Chief Medical Officer and Head of Research & Development at Ovid. “Specifically, we believe t...