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Ovid Therapeutics Provides Soticlestat (OV935/TAK-935) Results from ARCADE and ENDYMION Studies Showing Seizure Reduction in Rare Epilepsies
Results from signal-finding, pilot Phase 2 open-label ARCADE study and ENDYMION long-term extension study in CDKL5 deficiency disorder (CDD) and Dup15q
About this update from Ovid Therapeutics Inc.
[{"type":"text","content":"Results from signal-finding, pilot Phase 2 open-label ARCADE study and ENDYMION long-term extension study in CDKL5 deficiency disorder (CDD) and Dup15q syndrome (Dup15q) show seizure frequency reduction over time In CDD patients, median motor seizure frequency reduction was 24% in the ARCADE study, increasing to a 50% reduction in ENDYMION long-term extension study Clinical Global Impression of Change (CGI-C) and Caregiver Global Impression of Change (Care GI-C) suggest improvements beyond motor seizure frequency reduction in both CDD and Dup15q patients Soticlestat was generally well tolerated in both studies and continues to demonstrate a favorable safety profile NEW YORK, Sept. 30, 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 results from the ARCADE and ENDYMION studies of soticlestat (OV935/TAK-935) in patients with developmental and epileptic encephalopathies (DEEs), or rare epilepsies. The Phase 2 ARCADE study is a signal-finding open-label pilot study of soticlestat in patients with CDKL5 deficiency disorder (CDD) and Dup15q syndrome (Dup15q), two highly refractory rare epilepsies that have no approved treatment options, while ENDYMION is an open-label long-term extension study with soticlestat. All patients who completed the ARCADE study opted to roll over into ENDYMION. Soticlestat is a potent, highly selective, oral, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being developed in collaboration with Takeda Pharmaceutical Company Limited.\n Together, data from the ARCADE and ENDYMION studies show seizure frequency reduction over time. In CDD patients (n=12), median motor seizure frequency reduction was 24% during the 12-week maintenance period in the ARCADE study, increasing to a 50% reduction in the ENDYMION long-term extension study in the five CDD patients who reached nine months of continuous treatment. In Dup15q patients (n=8), there was an increase in median motor seizure frequency in the ARCADE study during the 12-week maintenance period; however, longer-term data from the four Dup15q patients who reached nine months of continuous treatment showed a 74% reduction in median motor seizure frequency. Soticlestat was generally ...