Suven announces positive topline results from Phase-2 study of Samelisant for EDS in adult narcolepsy patients with and without cataplexy

Suven Life Sciences announced positive topline results from its Phase-2 proof-of-concept study assessing 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 primary endpoint, with Samelisant demonstrating statistically significant and clinically meaningful reduction in EDS measured by the ESS total score compared to placebo at Day 14 (p<0.05).

A company statement informed, “Highly statistically significant effects were observed against placebo for the other efficacy endpoints like Clinical Global Impression of Severity (CGI-S) score related to EDS, Patient Global Impression-Change (PGI-C), and Clinical Global Impression of Change (CGI-C). Exposures of samelisant in narcolepsy patients were observed to be in agreement with the exposures from Phase-1 studies in healthy subjects. These plasma concentrations of samelisant were projected to be sufficient for achieving receptor occupancy required to demonstrate efficacy in narcolepsy patients. Samelisant was generally safe and well tolerated. There were no serious adverse events or death reported in the study.”

Topline data from this clinical trial are scheduled to be presented at the Neuroscience-2023 (Society for Neuroscience annual meeting) to be held at Washington, DC, US during November 12-15. The full study results are planned to be submitted for scientific publication at a later date.