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.
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.
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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