Monday, Takeda Pharmaceutical Co Ltd ( TAK ) announced topline data from its SKYLINE and SKYWAY Phase 3 studies of Soticlestat (TAK-935).

SKYLINE (TAK-935-3001) study evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome.

Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency compared to placebo (p-value = 0.06).

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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).

SKYWAY (TAK-935-3002) study evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Lennox-Gastaut syndrome.

Soticlestat missed the novel primary endpoint of reduction from baseline in Major Motor Drop seizure frequency compared to placebo.

In SKYLINE and SKYWAY studies, some pre-specified subgroups showed nominally significant treatment effects on the primary and secondary efficacy endpoints of caregiver and clinician global impression of improvement and seizure intensity and duration scales over the 16-week treatment period.

Further analyses are being conducted. Soticlestat was generally well tolerated.

In the ELEKTRA Phase 2 study, soticlestat demonstrated a statistically significant reduction of seizures from baseline compared to placebo (p-value = 0.002) in the combined Dravet syndrome and Lennox-Gastaut syndrome study population during the full treatment period.

In the Dravet cohort, a statistically significant reduction in convulsive seizure frequency from baseline compared to placebo (p-value = 0.0007) was also achieved.

In a pooled analysis of SKYLINE and the Dravet cohort of the Phase 2 ELEKTRA study, soticlestat also showed a reduction from baseline in convulsive seizure frequency compared to placebo (p-value = 0.001).

Takeda will engage with regulatory authorities to discuss the totality of the data generated by these studies to determine next steps.

Price Action: TAK shares are down 0.38% at $13.05 during the premarket session at last check Monday.