Ovid Therapeutics Inc. reported that Takeda Pharmaceutical Company Limited (Takeda) has announced topline data from its Phase 3 SKYLINE and SKYWAY studies evaluating soticlestat for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Proof of concept findings for OV888 (GV101) in cerebral cavernous malformations are anticipated in first first half of 2026. Ovid expects to initiate a Phase 2 proof-of-concept study in people living with CCMs in H2 2024 with an interim readout anticipated in first half of 2026.

Biomarker and safety data from a Phase 1 study of OV329 expected in H2 2024. OV329 is a highly potent GABA-aminotransferase inhibitor that is being developed for refractory seizures. First-in-human data for KCC2 direct activators (OV350) are expected in H1 2026.

Pot potassium chloride co-transporter 2 (KCC2) represents an exciting target in the brain that is implicated in many neurological and psychiatric disorders. Ovid plans to submit an investigational new drug application for OV350, which is a direct activator of KCC2, in a psychiatric indication in H2 2024. To enable Ovid to reach its milestones, it will prioritize activities and resources that have the most value-creating potential.

Pending review of the totality of the soticlestat data and discussions with regulators, Takeda will determine how it will proceed with regulatory steps. At that time, Ovid will update its guidance relative to any potential milestones and royalty payments pursuant to its royalty, license and termination agreement with Takeda.