Ovid stops preclinical and IV seizure projects after soticlestat's phase 3 failure

Ovid Therapeutics recently announced significant changes to its operational strategy in response to an unexpected setback with its epilepsy medication, soticlestat, which is developed in collaboration with Takeda. The company has decided to halt work on several preclinical programs, including an intravenous (IV) formulation of its seizure drug, OV329, to conserve resources and focus on its most promising assets.

Last month, Ovid revealed plans to reduce its workforce by 17 employees, approximately 43% of its staff, to prioritize its programs and extend its financial runway. The company's second-quarter earnings report provided further details about the pipeline changes, confirming the suspension of preclinical work and the discontinuation of the IV version of OV329. Despite these cutbacks, the oral formulation of OV329 remains a primary focus for Ovid. This version of the drug is a GABA-aminotransferase inhibitor intended for the chronic treatment of epilepsy, and the company expects to complete a phase 1 multiple ascending dose study by the end of the year.

Another major focus for Ovid is OV888/GV101, a ROCK2 inhibitor capsule developed in partnership with Graviton Bioscience. This drug is being prepared for a phase 2 study aimed at treating cerebral cavernous malformations. With $77 million in cash and equivalents, Ovid anticipates having sufficient funds to continue its operations into 2026.

Jeremy Levin, CEO of Ovid, contextualized these pipeline adjustments as a necessary response to the failure of soticlestat in reducing seizure frequency in patients with refractory Lennox-Gastaut syndrome during a phase 3 trial in June. Despite selling its rights to soticlestat to Takeda for $196 million in 2021, Ovid remains eligible for commercial milestones and royalties up to 20% on global net sales, should the drug eventually succeed.

Levin emphasized that following the disappointing phase 3 results, the company acted swiftly to reallocate resources and preserve capital. This reorganization included workforce reductions and a reassessment of ongoing programs to ensure that financial and clinical milestones could be achieved within the company's budget.

Takeda also faced repercussions from the phase 3 trial failure, recording a $140 million impairment charge. Nonetheless, Takeda remains optimistic that the comprehensive data set from the trials could still potentially secure FDA approval in the future.

In summary, Ovid Therapeutics is restructuring its operations and focusing on its most promising drug candidates following the unexpected setback with soticlestat. By halting preclinical programs and prioritizing key projects, the company aims to optimize its resources and extend its financial viability while working towards significant clinical advancements.