Takeda’s epilepsy drug soticlestat misses Phase III endpoints

Takeda (TYO: 4502), Japan’s largest drugmaker, today announced mixed top-line data from its SKYLINE and SKYWAY Phase III trials outcomes for its drug soticlestat.

SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase III study that evaluated soticlestat (TAK-935) plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome (DS). Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo (p-value = 0.06).

However, Takeda pointed out, among the six key secondary endpoints, soticlestat showed clinically meaningful and nominally significant results in the responder rate, measures of caregiver and clinician global impression of improvement, and seizure intensity and duration scales over the 16-week treatment period (all p-values ≤ 0.008).