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Takeda Says Phase 3 Soticlestat Trials in Dravet, Lennox-Gastaut Syndromes Missed Primary Endpoints
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Takeda Says Phase 3 Soticlestat Trials in Dravet, Lennox-Gastaut Syndromes Missed Primary Endpoints
Jun 17, 2024 5:17 AM

07:59 AM EDT, 06/17/2024 (MT Newswires) -- Takeda Pharmaceutical ( TAK ) said Monday its phase 3 trials evaluating soticlestat to treat refractory Dravet syndrome and Lennox-Gastaut syndrome missed the primary endpoints.

The study evaluating soticlestat in participants with Dravet syndrome "narrowly missed" the primary endpoint of reduction from baseline in convulsive seizure frequency compared to placebo, while the study in Lennox-Gastaut syndrome missed the novel primary endpoint of reduction from baseline in major motor drop seizure frequency compared to placebo, according to Takeda.

Soticlestat, an investigational inhibitor of cholesterol 24-hydroxylase, demonstrated "clinically meaningful and nominally significant results" in some secondary points in the Dravet trial, the company said.

Takeda said it is conducting further analyses and evaluating the financial effects of the trial results, including impairment loss for intangible assets, on fiscal Q1 ending June 30.

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