Suven Life Sciences, a pioneering biopharmaceutical company specializing in Central Nervous System (CNS) disorders, recently announced the successful completion of its Phase-2 proof-of-concept study for samelisant. This novel medication was tested for its efficacy in reducing excessive daytime sleepiness (EDS) among adult patients with narcolepsy, both with and without cataplexy. The study reached its primary endpoint, showcasing a statistically significant and clinically meaningful decrease in EDS, as indicated by the Epworth Sleepiness Scale (ESS) total score compared to a placebo at Day 14 (p<0.05).

High Efficacy Against Placebo in Clinical Endpoints

Notably, samelisant demonstrated highly statistically significant effects against a placebo for various other efficacy endpoints. These included measurements such as the Clinical Global Impression of Severity (CGI-S) score related to EDS, the Patient Global Impression-Change (PGI-C), and the Clinical Global Impression of Change (CGI-C). The samelisant exposures observed in narcolepsy patients were consistent with those from Phase-1 studies in healthy subjects, indicating effective receptor occupancy necessary for demonstrating efficacy in treating narcolepsy patients.

Safety and Tolerance Profile of Samelisant

Throughout the course of the study, samelisant was generally safe and well-tolerated. Notably, there were no serious adverse events or deaths reported, bolstering its profile as a potential therapy for EDS in narcolepsy. Venkat Jasti, Chairman & CEO of Suven Life Sciences, expressed excitement over these top-line results and the significant improvement observed for narcolepsy patients with samelisant as a monotherapy.

Details of the Phase-2 Clinical Study

The Phase-2 clinical study of samelisant was a randomized, double-blind, placebo-controlled trial aimed at assessing its safety and efficacy as a monotherapy in adult narcolepsy patients. Conducted across the USA and Canada, with participation from approximately 60 sites, the study recruited 190 patients aged 18 to 65 years. These participants were randomized into three groups to receive either 2 mg or 4 mg doses of samelisant or a placebo treatment. Primary and secondary endpoints of the study focused on changes in ESS total score and other related scores, providing comprehensive data on samelisant’s effectiveness in managing EDS and related narcolepsy symptoms.

Overview of Samelisant as a CNS Drug

Samelisant (SUVN-G3031) is a potent, selective, brain penetrant, and orally active Histamine-3 (H3) receptor inverse agonist. By blocking the H3 receptor, samelisant elevates levels of histamine, norepinephrine, and dopamine in the brain, demonstrating potential in the treatment of both EDS and cataplexy in narcolepsy patients. Exhibiting wake-promoting activity in pre-clinical models, samelisant’s development path includes successful neurochemical, pharmacokinetic, and safety studies, alongside Phase-1 trials in healthy subjects.

The announcement from Suven Life Sciences marks a significant milestone in the treatment of CNS disorders, particularly narcolepsy, offering hope and advanced therapeutic options for patients worldwide.

  India, narcolepsy, samelisant, Suven Life Sciences, Venkat Jasti