Takeda Reports Topline Data from P-III (SKYLINE and SKYWAY) Studies of Soticlestat for Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS)
Shots:
- SKYLINE study of soticlestat + SoC vs PBO + SoC for refractory DS did not meet the 1EP of reduced convulsive seizure frequency; significant outcomes in 2EPs of responder rate, caregiver & clinician global impressions of improvement plus seizure intensity & duration scales at 16wks. were observed
- SKYWAY study of soticlestat refractory LGS did not meet the 1EP of reduced MMD seizure frequency. Further analysis is underway
- Additionally, P-II (ELEKTRA) study of soticlestat vs PBO depicted reduced seizures (DS + LGS patients) & reduced convulsive seizure frequency (DS population & SKYLINE + DS population of ELEKTRA trial) from baseline. Data will be discussed with the regulatory authorities for next steps; anticipates P-III data at future conferences
Ref: Takeda | Image:Takeda
Related News: Takeda Signs an Exclusive License Agreement with Ovid for Soticlestat to Treat Dravet Syndrome and Lennox-Gastaut Syndrome
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