Suven Life Sciences Reports Positive DSMB Safety Review and Interim Analysis from Ongoing Global Phase 3 Study of Masupirdine in Alzheimer's Disease

Suven Life Sciences, a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, today 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 (AD).

The DSMB conducted a planned safety review after approximately 50% of randomized participants who had completed the 12 weeks of treatment. Based on a comprehensive evaluation of the unblinded safety data, the DSMB recommended that the trial to continue as planned and no modifications to the study design or conduct. No safety concerns were identified that would warrant any changes to the protocol or any additional follow up needed. In parallel, a pre-specified unblinded interim analysis was performed to assess sample size adequacy after approximately 50% of participants who had completed the 12 weeks of treatment period. Based on the analysis, DSMB recommended that no increase in sample size, supporting continuation of the trial as originally planned.

Enrollment continues to progress strongly, with approximately 88% of the planned patient population enrolled as on date. Based on the current enrollment trajectory, Suven expects to complete enrollment by the September 2026. Last patient last visit is anticipated in January 2027, with database lock and top-line results expected in Q2-2027. Given the continued acceleration in enrollment, the Company believes there is a potential to further advance these timelines.

"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," said Mr. Venkat Jasti, Chairman and Managing Director of Suven Life Sciences.

Shares of Suven Life Sciences Limited was last trading in BSE at Rs. 237.15 as compared to the previous close of Rs. 266.40. The total number of shares traded during the day was 181015 in over 2794 trades.

The stock hit an intraday high of Rs. 271.50 and intraday low of 236.00. The net turnover during the day was Rs. 44652001.00.

Source : Equity Bulls

Keywords

SuvenLifeSciences INE495B01038 Pharmaceuticals Outcome DSMB SUVN502 Masupirdine