Suven Life Sciences Limited announces the randomiation of first patient in the Phase-3 global clinical trial of Masupirdine for the treatment of agitation in patients with dementia of the Alzheimer's type.

The trial is a multicenter, randomized, double-blind, placebo-controlled study planned across 50 sites in the North America and Europe. The study will enroll approximately 375 patients who will be randomized in a 1:1:1 ratio to receive masupirdine either 50 mg QD or 100 mg QD or placebo QD for 12 weeks. The primary outcome measure is Cohen-Mansfield Agitation Inventory (CMAI) - Change in the CMAI items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains from baseline to Week 12. Key secondary outcome measure is modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) scale as related to the agitation. Topline data from the trial is expected to be available by early 2025. Additional information on the trial can be found at ClinicalTrials.gov (NCT05397639).

About Masupirdine

Masupirdine, a serotonin-6 (5-HT6) receptor antagonist is being developed for the treatment of agitation in patients with dementia of the Alzheimer's type. In animal models, masupirdine showed significant reduction in agitation like behavior and modulated the neurotransmitters implicated in mood and behavior. Post-hoc analyses of the Phase 2 study (NCT02580305) evaluating masupirdine for the treatment of cognitive deficits in patients with moderate Alzheimer's disease (AD) suggested potential beneficial effects on agitation/aggression.

About Suven Life Sciences Limited ('Suven'):

Suven is a bio-pharmaceutical company, focused on discovering and developing novel pharmaceutical products, for central nervous system ('CNS') disorders using G ProteinCoupled Receptor targets. Our focus has been on discovery and development of innovative molecules targeting diseases and areas, which has undiscovered medical treatment opportunities. Our Company singularly focuses on development of 'New Chemical Entities' ('NCEs') molecules for CNS diseases such as Alzheimer's, various forms of Dementia, Narcolepsy, Major Depressive Disorder ('MDD'), Attention Deficient Hyperactivity Disorder ('ADHD'), Huntington's disease, Parkinson, Bipolar disorder and different forms of neuropsychiatry disorders, gastro and pain. Suven has 7 clinical stage compounds, including this Phase 3 Masupirdine (SUVN-502) for treatment of agitation in patients with dementia of the Alzheimer's type, ongoing Phase 2 Samelisant (SUVN-G3031) for sleep disorders (Narcolepsy), Phase 2 ready Ropanicant (SUVN-911) for Major Depressive Disorder (MDD) and Phase 2 ready Usmarapride (SUVN-D4010) for cognitive disorders. In addition to clinical candidates, Suven has 8 molecules in development pipeline.

Contact:

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