Business Update30 Oct 2023, 08:05 pm
Suven Life Sciences Announces Positive Topline Results from Phase-2 Study of Samelisant for Narcolepsy
AI Summary
Suven Life Sciences, a clinical stage biopharmaceutical company, has announced positive topline results from its Phase-2 proof-of-concept study evaluating the safety and efficacy of samelisant for the treatment of excessive daytime sleepiness (EDS) in adult narcolepsy patients with and without cataplexy. The study met its primary endpoint, with samelisant demonstrating a statistically significant and clinically meaningful reduction in EDS measured by the ESS total score compared to placebo at Day 14 (p<0.05).,
Key Highlights
- Suven Life Sciences announces positive topline results from Phase-2 study of samelisant for narcolepsy
- Samelisant demonstrates statistically significant and clinically meaningful reduction in EDS compared to placebo
- No serious adverse events or death reported in the study
- Suven plans to approach U.S. Food & Drug Administration (FDA) in Q1 2024 for an End-of-Phase-2 (EOP2) meeting