Clinical Trial Update

Suven Life Sciences 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.

DSMB Review Findings

The DSMB conducted a planned safety review after approximately 50% of randomized participants had completed the 12 weeks of treatment. Based on comprehensive evaluation of unblinded safety data:

  • The DSMB recommended that the trial continue as planned
  • No modifications to the study design or conduct were recommended
  • No safety concerns were identified that would warrant protocol changes
  • No additional follow-up was deemed necessary

Interim Analysis Results

A pre-specified unblinded interim analysis was performed to assess sample size adequacy after approximately 50% of participants completed the 12-week treatment period:

  • DSMB recommended no increase in sample size
  • Trial will continue as originally planned

Enrollment Status and Timeline

Enrollment progress:

  • Approximately 88% of planned patient population enrolled as of June 4, 2026
  • Enrollment completion expected by September 2026
  • Last patient last visit anticipated in January 2027
  • Database lock and top-line results expected in Q2 2027

The company notes potential to further advance these timelines due to continued acceleration in enrollment.

Management Commentary

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."

Trial Design Details

The Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled trial conducted across approximately 80 sites in:

  • North America (USA)
  • Europe (Poland, Serbia, and Croatia)

Study parameters:

  • 375 patients randomized 1:1:1 to receive Masupirdine 50 mg QD, 100 mg QD, or Placebo
  • 12-week treatment duration
  • Primary endpoint: Change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items aligned with International Psychogeriatric Association (IPA) agitation criteria
  • Key secondary endpoint: Modified Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change (mADCS-CGI-C) related to agitation

Company Background

Suven Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders. The company has a portfolio of advanced stage clinical candidates and research programs for CNS disorders including Alzheimer's disease, Sleep disorders, Major depressive disorders, Parkinson's disease, Schizophrenia, Pain disorders, and Gastrointestinal disorders.

Clinical stage assets mentioned:

  • Masupirdine (SUVN-502) for agitation in Alzheimer's dementia (Global Phase-3 ongoing)
  • Samelisant (SUVN-G3031) for excessive daytime sleepiness in narcolepsy (Phase-2 completed for EDS; Phase-2 for Cataplexy and Phase-3 for EDS in planning)
  • Ropanicant (SUVN-911) for MDD (Phase-2a completed; Phase-2b ongoing)
  • Usmarapride (SUVN-D4010) for cognitive disorders (Phase-2 in planning)
  • SUVN-I6107 for cognitive disorders (Phase-1 in progress)

The company owns all intellectual property rights for its assets in all major markets.