Takeda’s Soticlestat Misses Primary Endpoints in Phase III Epilepsy Trials

Takeda Pharmaceutical Co., Ltd (TYO: 4502; NYSE: TAK), a leading Japanese pharmaceutical company, has announced that its drug candidate soticlestat did not meet the primary endpoints in two Phase III trials. The drug is currently under development for the treatment of two rare forms of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome—and failed to demonstrate a reduction in seizure frequency after a four-month treatment period, although some secondary benefits were observed.

Soticlestat was obtained from Ovid Therapeutics (NASDAQ: OVID), a U.S.-based biotech firm, in a deal inked in 2021. At that time, Ovid had successfully completed early- and mid-stage clinical development, and Takeda expressed its confidence in the molecule with a USD 196 million upfront payment. This was part of a commitment to up to USD 856 million in combined upfront and milestone payments for global development rights. Following the news of the trial failure, Ovid’s shares experienced a significant drop of approximately 66%.

Takeda has stated that it intends to continue working with the U.S. Food and Drug Administration (FDA) to explore potential paths forward for soticlestat.- Flcube.com

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