Takeda's Soticlestat Misses Goals in Phase 3 Epilepsy Studies

By Colin Kellaher

Takeda Pharmaceutical on Monday said a pair of late-stage studies of its soticlestat drug candidate missed their key goals in two severe forms of epilepsy.

Takeda said a Phase 3 study of soticlestat plus standard of care narrowly missed its primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo in patients with refractory Dravet syndrome.

The Osaka, Japan, drugmaker also said a separate Phase 3 study of soticlestat plus standard of care missed its novel primary endpoint of reduction from baseline in major-motor-drop seizure frequency as compared to placebo in patients with refractory Lennox-Gastaut syndrome.

Takeda said it plans to discuss the study results with regulatory authorities to determine its next steps, adding that it is assessing the financial impacts, including an impairment loss for intangible assets.

Ovid Therapeutics, a biopharmaceutical company that co-developed soticlestat through Phase 2 and then sold its rights to Takeda, retaining financial interests to the drug, on Monday said that its R&D and financial strategy is independent of soticlestat's outcome.

New York-based Ovid also said it has a cash runway into the first half of 2026, and that it will update its guidance on potential milestones and royalty payments under its agreement with Takeda after its partner determines how it will proceed on soticlestat.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 17, 2024 07:31 ET (11:31 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.