Suven Life Sciences Limited will present three posters detailing the clinical advancement of Samelisant (SUVN-G3031) at the SLEEP-2026 Annual Meeting in Baltimore, USA. The presentations, scheduled for June 14-17, 2026, will highlight positive Phase-2 efficacy data in excessive daytime sleepiness (EDS), the rationale for a Phase-2 study in cataplexy, and the Phase-3 development strategy for narcolepsy. The SLEEP meeting is the 40th annual conference of the Associated Professional Sleep Societies (APSS), a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society.

The first poster, scheduled for June 15, 2026 (Poster # 374), will demonstrate the significant reduction in EDS in patients with narcolepsy based on Phase-2 results. Also on June 15, a second presentation (Poster # 368) will outline the study design and rationale for a Phase-2 trial of Samelisant for treating cataplexy in Type 1 narcolepsy. The third poster, set for June 16, 2026 (Poster # 332), will cover the Phase-3 clinical development, rationale, and study design for treating EDS in narcolepsy patients.

Samelisant is one of five clinical-stage assets in Suven Life Sciences 's portfolio focused on Central Nervous System (CNS) disorders. The company's pipeline includes Masupirdine (SUVN-502) for agitation in Alzheimer's disease, which is in a global Phase-3 study, and Ropanicant (SUVN-911) for Major Depressive Disorders. Suven retains all intellectual property rights for its assets across major markets.

Poster Presentations

Members of the Suven scientific team will hold meetings at Exhibit Booth # 1034 with Phase-3 study Principal Investigators, Key Opinion Leaders (KOLs), and potential partnering companies during the conference.

Suven Life Sciences has announced positive outcomes from an independent Data and Safety Monitoring Board (DSMB) review and a pre-specified interim analysis of its ongoing global Phase 3 study evaluating Masupirdine (SUVN-502) for the treatment of agitation associated with Alzheimer's disease. The DSMB recommended that the trial continue as planned without modifications to the study design or conduct, following a comprehensive evaluation of unblinded safety data from approximately 50% of randomized participants who had completed 12 weeks of treatment. No safety concerns were identified that would warrant changes to the protocol or additional follow-up.

In parallel, a pre-specified unblinded interim analysis was performed to assess sample size adequacy. Based on this analysis, the DSMB recommended no increase in sample size, supporting the continuation of the trial as originally planned. Enrollment continues to progress strongly, with approximately 88% of the planned patient population enrolled as of June 4, 2026. The company expects to complete enrollment by September 2026, with the last patient last visit anticipated in January 2027. Database lock and top-line results are expected in Q2-2027. Given the continued acceleration in enrollment, the company believes there is a potential to further advance these timelines.

Study Details

The trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study conducted across approximately 80 sites in North America and Europe. Approximately 375 patients will be randomized 1:1:1 to receive Masupirdine 50 mg QD, 100 mg QD, or Placebo for 12 weeks. Key study parameters are outlined below:

The primary endpoint is the change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items aligned with the International Psychogeriatric Association (IPA) agitation criteria. A key secondary endpoint is the modified Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C) related to agitation.

Management Commentary

"We are pleased to report another positive safety review for Masupirdine, with the DSMB recommending continuation of the trial without modification, marking a key milestone in its development," said Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences. "To date, over 88% of study participants have been enrolled, reflecting strong execution and sustained momentum. We remain fully committed to the program, with patient enrolment on track for completion by the end of calendar year 2026."