Soticlestat

The oral version of OV329—a GABA-aminotransferase inhibitor for the chronic treatment of epilepsies—will remain one of Ovid Therapeutics' top priorities. Ovid Therapeutics already revealed last month that it was trimming back its headcount as the company navigates an unexpected setback for the Takeda-partnered epilepsy med soticlestat. Now, the biotech has confirmed that it’s halting work on its preclinical programs, including an intravenous (IV) formulation of its seizure drug in order to save cash.The company already made clear in a regulatory filing at the time that laying off 17 people—equivalent to 43% of Ovid’s workforce—in July was spurred by a need to “prioritize its programs and extend its cash runway.”In its second-quarter earnings report this morning, the biotech spelt out what pipeline changes it had in mind. The company is halting its preclinical work—although the only high-profile casualty will be the IV formulation of OV329.While Ovid also referred to “other preclinical programs” as facing the axe, it didn’t go into further details.Instead, the oral version of OV329—a GABA-aminotransferase inhibitor for the chronic treatment of epilepsies—will remain one of the company’s top priorities. A phase 1 multiple ascending dose study is expected to wrap up this year. The other key priority for Ovid is OV888/GV101, a Graviton Bioscience-partnered ROCK2 inhibitor capsule that is being lined up for a phase 2 study in cerebral cavernous malformations. With $77 million to hand in cash and equivalents, the company expects to pave a cash runway into 2026.Ovid CEO Jeremy Levin put the pipeline changes in the context of the failure of soticlestat to reduce seizure frequency in patients with refractory Lennox-Gastaut syndrome, a severe form of epilepsy, in a phase 3 trial in June. Ovid sold its rights to the cholesterol 24 hydroxylase inhibitor to Takeda for $196 million back in 2021 but is still in line for commercial milestones and low double-digit royalties up to 20% on global net sales.“Following Takeda's unexpected phase 3 results for soticlestat, we moved rapidly to focus our resources to preserve capital,” Levin said in today’s release. “This approach included restructuring the organization and initiating ongoing program prioritization efforts to support the achievement of meaningful clinical and regulatory milestones within our financial plan.”Takeda was also taken aback by soticlestat’s failure. The Japanese pharma notched a $140 million impairment charge as a result of the phase 3 miss. Still, Takeda said recently that it still holds some hope that the “totality of the data” could one day earn an FDA nod anyway.