Suven Life Sciences announces positive phase-2 results for samelisant; stock jumps 20% and hits upper circuit

Suven Life Sciences, a clinical-stage biopharmaceutical company focused on discovering and developing new treatments for Central Nervous System (CNS) disorders, has released positive preliminary results from its Phase-2 proof-of-concept study evaluating the safety and effectiveness of samelisant in addressing excessive daytime sleepiness (EDS) in adult narcolepsy patients, both with and without cataplexy.

The results showed highly statistically significant improvements over placebo in other key efficacy measures, such as the Clinical Global Impression of Severity (CGI-S) score related to EDS, Patient Global Impression-Change (PGI-C), and Clinical Global Impression of Change (CGI-C).

Furthermore, samelisant exposure in narcolepsy patients appeared consistent with the results of Phase-1 studies involving healthy subjects. These plasma concentrations of samelisant were estimated to be sufficient for achieving the desired receptor occupancy required to demonstrate effectiveness in narcolepsy patients. Samelisant demonstrated a generally safe and well-tolerated profile, with no reports of serious adverse events or fatalities in the study.

“We are thrilled by these compelling topline results and the magnitude of improvement observed for narcolepsy patients in this study with Samelisant as a monotherapy,” said Venkat Jasti, Chairman & CEO of Suven Life Sciences. “We are deeply grateful to the patients and investigators who participated in the study”, said Venkat Jasti, Chairman & CEO of Suven Life Sciences.

Following the announcement, the stock surged by 19.99% during the intraday session, hit the upper circuit, and finally concluded the day at Rs 75.56, which is a 20% increase from its Friday’s closing price of Rs 62.97 per share on the BSE. The current market capitalisation of the company stands at Rs 1,647 crore, and the stock has delivered a 32% return in the last six months.

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About Samelisant (SUVN-G3031) Phase-2 Study:

The Phase-2 clinical trial was a double-blind, randomized, and placebo-controlled study designed to evaluate the safety and effectiveness of samelisant as a standalone treatment for adult narcolepsy patients, both those with and without cataplexy. This trial was registered under the identifier ClinicalTrials.gov and was conducted in the United States and Canada, involving participation from approximately 60 research sites. The study enrolled 190 patients, aged between 18 and 65 years, who were randomly assigned in a 1:1:1 ratio to receive either a 2 mg dose of samelisant, a 4 mg dose of samelisant, or a placebo.

The primary goal of this study was to measure the change in the total ESS (Excessive Sleepiness Scale) score from baseline to Day 14. Secondary and exploratory endpoints included assessing changes in the CGI-S (Clinical Global Impression of Severity) score, CGI-C (Clinical Global Impression of Change) score, and PGI-C (Patient Global Impression of Change) score in relation to excessive daytime sleepiness, as well as measuring changes in the Maintenance of Wakefulness Test score from baseline to Day 14.

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