Suven Life Sciences set to begin samelisant phase 2 trial in narcolepsy

Suven Life Sciences has announced the successful completion of enrollment for its phase-2 proof-of-concept (PoC) clinical study to evaluate the safety and efficacy of samelisant in adult narcolepsy patients, with and without cataplexy in the US and Canada.

The Indian clinical-stage biopharmaceutical company, which specializes in central nervous system (CNS) disorder therapies, anticipates releasing the study’s data in the second quarter of the fiscal year 2024.

Narcolepsy, a chronic disease characterized by excessive daytime sleepiness (EDS) and cataplexy, poses significant challenges to patients’ quality of life. Samelisant, designed to increase histamine transmission in the brain, holds promise as a potential treatment for managing narcolepsy.

The phase-2 PoC clinical study follows a double-blind, placebo-controlled, parallel-group, multicenter design. Its objective is to assess the safety, tolerability, pharmacokinetics, and efficacy of samelisant at 2 mg and 4 mg doses compared to a placebo. Roughly 190 adult patients were randomly assigned in a 1:1:1 ratio to receive either 2 mg samelisant, 4 mg samelisant, or placebo.

The study will be conducted at 58 clinical sites across the United States and Canada.

The primary efficacy endpoint of the study is the change in the mean Maintenance of Wakefulness Test (MWT) score at Day 14, while a key secondary endpoint is the change in the mean total Epworth Sleepiness Scale (ESS) score at Day 14.

Patient baseline characteristics and demographics from the phase-2 PoC study of samelisant will be presented at SLEEP 2023, the 37th annual meeting of the Associated Professional Sleep Societies, LLC (APSS). The event is scheduled to take place in Indianapolis, USA, from June 3-7, 2023.

Samelisant (SUVN-G3031), an orally active Histamine H3 receptor inverse agonist, demonstrates unique properties as a potent and selective treatment option. By blocking the H3 receptor, samelisant increases histamine, norepinephrine, and dopamine levels in the brain, potentially alleviating excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.

Preclinical studies, including in vitro and in vivo efficacy assessments, neurochemical studies, pharmacokinetic evaluations, safety studies, and phase-1 clinical trials involving healthy human subjects, have been successfully completed for samelisant under a US investigational new drug (IND) application.

Venkat Jasti — Suven Life Sciences Chairman and CEO said: “We are pleased to have achieved this milestone in the development of samelisant for the treatment of narcolepsy and eagerly await the data readout in the second quarter of FY2024.”