Ovid Halts Preclinical Work and IV Seizure Program Following Soticlestat’s Phase 3 Setbacks

Phase 3 Trial Outcomes:

Soticlestat, licensed from Ovid Therapeutics, failed to meet primary efficacy endpoints in Phase 3 trials for Dravet syndrome and Lennox-Gastaut syndrome.
The drug narrowly missed the primary endpoint in the Dravet syndrome trial (SKYLINE) with a p-value of 0.06, but showed clinically meaningful effects in secondary endpoints.
The Lennox-Gastaut syndrome trial (SKYWAY) did not significantly reduce Major Motor Drop seizures.

Safety and Tolerability:

Soticlestat demonstrated a consistent and favorable safety and tolerability profile in both studies.

Regulatory Plans:

Takeda will engage with regulatory authorities to discuss the totality of the data and determine the next steps for soticlestat.

Ovid’s Response:

Ovid has halted preclinical work and its intravenous (IV) seizure program following the Phase 3 setbacks.
Ovid’s CEO, Jeremy Levin, expressed disappointment but emphasized the company’s independent R&D and financial strategy, which is not dependent on soticlestat’s outcome.

Financial Implications:

Takeda is assessing the financial impacts of the Phase 3 failures on its first-quarter earnings.
Ovid’s cash runway is expected to last into the first half of 2026, with several clinical milestones anticipated from its differentiated pipeline.