Suven Life Sciences Reaches 76% Enrollment Milestone in Global Phase 3 Masupirdine Trial
Suven Life Sciences Limited, a clinical-stage biopharmaceutical company focusing on central nervous system (CNS) disorders, announced that it has reached a 76% enrollment milestone for its proprietary Phase 3 global study of Masupirdine (SUVN-502). The trial is investigating the use of Masupirdine for the treatment of agitation in patients suffering from dementia of the Alzheimer's type (AAD).The multi-center, randomized, double-blind, placebo-controlled Global Phase-3 study, identified by NCT05397639 and EudraCT Number 2021-003405-22, is enrolling patients across North America (USA) and Europe.
During the press release, Venkat Jasti, Chairman and Managing Director of Suven Life Sciences, stated that the milestone reflects continued momentum in the program. He noted that the completion of patient enrollment by the end of calendar year 2026 is certain, with the last patient visit anticipated in the first quarter of 2027. This timeline enables the potential progression towards database lock and the reporting of results in the second or third quarter of the 2027 calendar year. Mr. Jasti added that enrollment activity has been accelerated through the deployment of additional resources, experienced investigators, medical experts, and AI-enabled patient identification and referral.
Dr. Ramakrishna Nirogi, President and CSO of Suven Life Sciences, highlighted the medical need for Masupirdine. He explained that agitation is a frequent neuropsychiatric symptom of dementia associated with Alzheimer's disease, often leading to increased caregiver burden. He noted that Masupirdine, a pure, potent, and selective 5-HT6 receptor antagonist, possesses the potential to offer a differentiated, non-dopaminergic, non-sedative approach to managing Alzheimer's agitation, aiming for dual impact on behavioral stabilization and cognition.
The trial is designed to enroll approximately 375 patients, who will be randomized in a 1:1:1 ratio to receive one of three treatments for 12 weeks.
Masupirdine Agitation Study Details
The study is a multinational effort conducted across approximately 80 sites in North America and Europe. Key details regarding the clinical trial are as follows:| Parameter | Detail |
|---|---|
| Target Condition | Agitation in patients with dementia of the Alzheimer's type (AAD) |
| Trial Phase | Global Phase 3 |
| Patient Count | Approximately 375 |
| Study Sites | Approximately 80 sites (North America & Europe) |
| Treatment Arms | Masupirdine 50 mg QD, Masupirdine 100 mg QD, or Placebo |
| Primary Endpoint | Change from baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) items aligned with the International Psychogeriatric Association (IPA) agitation criteria. |
| Secondary Endpoint | Modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (mADCS-CGI-C) related to agitation. |
Suven and its CRO teams have set internal goals, aiming for Last Patient In (LPI) by September 2026 and Last Patient Last Visit (LPLV) by January 2027, with data readout expected by April 2027.
Suven Life Sciences is dedicated to the discovery and clinical development of innovative medicines addressing unmet medical needs in CNS disorders. The company maintains a portfolio that spans several focus areas, including Alzheimer's disease (AD), sleep disorders, major depressive disorders (MDD), Parkinson's disease (PD), and schizophrenia.
Current clinical assets within the company's focus areas include:
- Masupirdine (SUVN-502): Global Phase-3 study for agitation in AAD.
- Samelisant (SUVN-G3031): Phase-2 study completed for excessive daytime sleepiness (EDS) in narcolepsy; planning for Phase-3 study.
- Ropanicant (SUVN-911): Phase-2a and Phase-2b studies completed for MDD.
- Usmarapride (SUVN-D4010): Phase-2 study in planning for cognitive disorders.
- SUVN-I6107: Phase-1 study in progress for cognitive disorders.
Additionally, Suven maintains a research pipeline encompassing seven projects across multiple indications.
SUVEN Stock Price Movement
Shares of Suven Life Sciences Limited are edging higher to ₹219 as of 3:19 PM today, gaining 0.54% in live trading. The stock is currently exhibiting strong momentum, processing 342,909 shares during the afternoon session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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