Takeda’s Soticlestat Misses Main Goal in Two Pivotal Epilepsy Studies

1. Trial Results: Takeda's soticlestat failed to meet the primary endpoints in two Phase 3 studies (SKYLINE and SKYWAY) for treating Dravet syndrome and Lennox-Gastaut syndrome, respectively.
2. Seizure Frequency: While soticlestat did not significantly reduce seizure frequency compared to placebo, it showed promising results in secondary measures such as seizure intensity and duration.
3. Statistical Significance: The p-value for the primary endpoint was 0.06, indicating a 6% chance that the results were due to random chance, which is just above the threshold for statistical significance.
4. Secondary Measures: Soticlestat outperformed placebo in several secondary measures, including caregiver- and clinician-rated measures of improvement, with p-values of 0.008 or lower.
5. Safety Profile: The drug was generally well tolerated, with a safety profile consistent with earlier studies.
6. Future Plans: Takeda will engage with regulatory authorities to determine the next steps for soticlestat's development and will present detailed results at scientific conferences in the future.