Suven Life Sciences, a clinical-stage biopharmaceutical company focused on the development of novel treatments for Central Nervous System (CNS) disorders, is set to present significant study results at the 76th American Academy of Neurology (AAN) Annual Meeting. The event will take place from April 13 to 18, 2024, in Denver, USA, as well as virtually.

The AAN Annual Meeting is renowned as the world’s largest gathering of neurologists and neuroscience professionals, providing a platform for education and the latest scientific and clinical updates. Suven Life Sciences will highlight the positive outcomes of its Phase-2 proof-of-concept study on samelisant during the meeting. This study, aimed at treating excessive daytime sleepiness (EDS) in adult patients with narcolepsy, has successfully met its primary endpoint, showing a statistically significant and clinically meaningful reduction in EDS, as measured by the Epworth Sleepiness Scale (ESS) total score compared to placebo at Day 14 (p<0.05).

Detailed results also demonstrated highly significant effects against placebo in other efficacy endpoints related to EDS, including the Clinical Global Impression of Severity (CGI-S) score, Patient Global Impression-Change (PGIC), and Clinical Global Impression of Change (CGI-C). The presentation, titled “Samelisant (SUVN-G3031) – Clinical efficacy and safety outcome from the Phase-2 Proof-of-Concept Double-blind, Placebo-controlled Study in Patients with Narcolepsy,” is scheduled for Wednesday, April 17, 2024.

In addition to presenting these findings, Suven’s team of chief scientists will engage with key opinion leaders (KOLs), principal investigators (PIs), and medical and regulatory advisors to discuss the design of a global Phase-3 study. This study aims to evaluate samelisant for the treatment of EDS in adult narcolepsy patients both with and without cataplexy, with initiation expected in the latter half of 2024.

The Phase-2 clinical study was a randomized, double-blind, placebo-controlled trial conducted across approximately 60 sites in the USA and Canada. It involved 190 patients aged 18 to 65 years who were randomized into three groups to receive either 2 mg samelisant, 4 mg samelisant, or placebo. The primary focus was on the change in ESS total score from baseline to Day 14, with secondary and exploratory endpoints evaluating changes in CGI-S score, CGI-C score, PGI-C score, and Maintenance of Wakefulness Test score over the same period.

Samelisant, developed by Suven Life Sciences, is a novel, potent, selective, brain-penetrant, and orally active Histamine-3 (H3) receptor inverse agonist. By blocking H3 receptors, it elevates levels of histamine, norepinephrine, and dopamine in the brain, which are crucial for treating EDS and cataplexy. The drug has shown promising wake-promoting activity in orexin knock-out mice, a model used to study narcolepsy, and has successfully completed pre-clinical in vitro and in vivo efficacy studies, neurochemical studies, pharmacokinetic studies, safety studies, and Phase-1 trials under US IND.

The promising results of Suven Life Sciences’ Phase-2 study are a significant milestone in the treatment of narcolepsy, particularly in managing EDS. The advancements in understanding and potentially treating such disorders highlight the crucial role of innovative CNS-focused research in improving patient outcomes.

  AAN 2024, CNS disorder treatments, Phase-2 clinical trials, samelisant, samelisant narcolepsy treatment, Suven Life Sciences