Suven Life Sciences announced completion of enrollment for its phase-2 PoC clinical study evaluating the safety and efficacy of samelisant in adult narcolepsy patients with and without cataplexy. Data readout for the study is anticipated in second quarter of fiscal year 2024. About Study Design: This phase-2 PoC clinical trial is a double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of 2 mg and 4 mg samelisant compared with placebo in narcolepsy patients with & without cataplexy.

Approximately 190 adult patients were randomized at a ratio of 1:1:1 to 2 mg samelisant, 4 mg samelisant, or placebo at 58 clinical study sites across the USA and Canada (ClinicalTrials.gov Identifier: NCT04072380). The primary efficacy endpoint is change from baseline in the mean Maintenance of Wakefulness Test (MWT) score at Day 14. Key secondary endpoint is change from baseline in The mean total Epworth Sleepiness Scale (ESS) score at Day 14.