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Ovid Therapeutics Reports on Takeda’s Announcement of Phase 3 Topline Study Results for Soticlestat
Takeda’s Skyline study in Dravet syndrome narrowly missed its primary endpoint of reduction in convulsive seizure frequency and showed clinically meaningful
About this update from Ovid Therapeutics Inc.
[{"type":"text","content":"Takeda’s Skyline study in Dravet syndrome narrowly missed its primary endpoint of reduction in convulsive seizure frequency and showed clinically meaningful and significant effects in multiple key secondary efficacy endpoints all with p-values ≤ 0.008Takeda’s Skyway study in Lennox-Gastaut syndrome missed its primary endpoint of reduction in major motor drop seizuresSoticlestat had a consistent and favorable safety and tolerability profile in both studiesTakeda will move forward to discuss the totality of the data with regulatory authoritiesWith the upfront milestone payment received from Takeda in 2021, Ovid built a differentiated pipeline with novel programs, including two clinical programs (OV888 entering Phase 2 and OV329 completing a Phase 1 with efficacy biomarkers) and a KCC2 direct activator library (first preclinical program, OV350, expected to move into the clinic in 2025)Ovid will prioritize and pursue its programs with financial discipline and expects its cash runway to last into the first half of 2026, and Ovid anticipates several clinical milestones between now and then NEW YORK, June 17, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company dedicated to meaningfully improving the lives of people affected by rare epilepsies and brain conditions, reports 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). Dr. Jeremy Levin, D. Phil, MB Chir, Chairman and CEO of Ovid, stated, “We are surprised and disappointed with the primary endpoint results. Soticlestat has a unique mechanism of action and a favorable tolerability profile, though its potential was not elucidated in SKYWAY. While SKYLINE narrowly missed its primary endpoint, we believe there are indications of effect in the secondary endpoints and the totality of the data in DS patients. Takeda is thoughtfully evaluating that data to inform the path forward with regulatory authorities.” “After selling our rights back to Takeda three years ago, we have built an exciting and differentiated pipeline, which we believe will generate multiple value-creating opportunities in the near-term. Our R&D and financial strategy is independent of soticlestat’s outcome. We will...