Suven Life Sciences announced scientific presentation at the upcoming 76th American Academy of Neurology (AAN) annual meeting being held April 13-18, 2024, in Denver, USA and virtually. The AAN Annual Meeting is the world's largest gathering of neurologists and neuroscience professionals and offers top-tier education and the latest in scientific discoveries, clinical updates, and many more from around the globe. Suven's scientific presentation at AAN will highlight details of the positive study 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 Epworth Sleepiness Scale (ESS) total score compared to placebo at Day 14 (p<0.05). Highly statistically significant effects were observed against placebo for the other efficacy endpoints related to EDS like Clinical Global Impression of Severity (CGI-S) score, Patient Global Impression-Change (PGI- C), and Clinical Global Impression of Change (CGI-C). About Samelisant (SUVN-G3031) Phase-2 Study: The Phase-2 clinical study was a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of samelisant as a monotherapy in adult narcolepsy patients with and without cataplexy (ClinicalTrials.gov Identifier: NCT04072380).

The study was conducted in USA and Canada and approximately 60 sites participated in this study. The study recruited 190 patients aged 18 to 65 years and were randomized 1:1:1 to 2 mg samelisant, 4 mg samelisant, or placebo treatment groups. The primary efficacy endpoint of this study was change in ESS total score from baseline to Day 14.

Secondary and exploratory endpoints were change in CGI-S score, CGI-C score and PGI-C score with regard to EDS and change in Maintenance of Wakefulness Test score from baseline to Day 14. About Samelisant (SUVN-G3031): Samelisant is a novel, potent, selective, brain penetrant, and orally active Histamine-3 (H3) receptor inverse agonist. H3 receptor blockade elevates histamine, norepinephrine, and dopamine in the brain, a potential for the treatment of EDS and cataplexy.

Samelisant exhibited wake-promoting activity in orexin knock-out mice (an animal model of narcolepsy). Pre-clinical in vitro and in vivo efficacy studies, supporting neurochemical studies, pharmacokinetic studies, safety studies and Phase-1 studies in healthy subjects under US IND have been successfully completed for samelisant.