Suven Life Sciences begins Masupirdine phase 3 clinical trial in dementia patients


Suven Life Sciences has started a global phase 3 clinical trial of Masupirdine in dementia of the Alzheimer’s type by randomizing the first patient.

According to the Indian biopharma company, the late-stage trial of the serotonin-6 (5-HT6) receptor antagonist is a double-blind, placebo-controlled study intended to be held in 50 sites in North America and Europe.

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The study of Masupirdine will feature nearly 375 patients, who will be randomly grouped in a 1:1:1 ratio to be subjected to masupirdine either 50 mg QD or 100 mg QD or placebo QD for a duration of 12 weeks.

Suven Life Sciences said that the primary outcome measure of the Masupirdine phase 3 trial is change in the Cohen-Mansfield Agitation Inventory (CMAI) items score aligning to the International Psychogeriatric Association (IPA) agitation criteria domains from baseline to the 12th week.

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The key secondary outcome measure of the trial is modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGI-C) scale with respect to the agitation.

Suven Life Sciences expects to release topline data from the Masupirdine phase 3 trial by early 2025.

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