Suven Life Sciences Limited 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 conducted a planned safety review after approximately 50% of randomized participants completed 12 weeks of treatment. Based on a comprehensive evaluation of the unblinded safety data, the DSMB recommended that the trial continue as planned without modifications to the study design or conduct, identifying no safety concerns. Concurrently, a pre-specified interim analysis assessed sample size adequacy. The DSMB recommended no increase in sample size, supporting the continuation of the trial as originally planned. Enrollment is progressing strongly, with approximately 88% of the planned patient population enrolled as of June 4, 2026. Suven expects to complete enrollment by September 2026, with the last patient's last visit anticipated in January 2027. Top-line results are expected in Q2-2027. The company believes there is a potential to advance these timelines due to the accelerated enrollment. Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, stated, "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. 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." The Phase 3 trial is a multicenter, randomized, double-blind, placebo-controlled study across approximately 80 sites in North America (USA) and Europe. Around 375 patients will be randomized 1:1:1 to receive Masupirdine 50 mg QD, 100 mg QD, or Placebo for 12 weeks. 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.
