BioXcel Says TRANQUILITY II Phase 3 Study Of BXCL501 Met Its Primary Goal

(RTTNews) - BioXcel Therapeutics, Inc. (BTAI) Thursday said late-stage study of the company's drug candidate BXCL501 for the acute treatment of Alzheimer's disease-related agitation met its primary goal.

In the Phase 3 study dubbed TRANQUILITY II, 149 patients with mild to moderate dementia were randomly dosed with 40 mcg or 60 mcg of BXCL501 or placebo for agitation episodes that occurred over a 12-week period.

The study met its primary endpoint with the 60 mcg dose, with statistically significant 39% greater reduction in Positive and Negative Syndrome Scale-Excitatory Component (PEC) score from baseline compared to placebo at 2 hours, the company said.

Key secondary endpoint of statistically significant reduction in agitation symptoms versus placebo as measured by PEC score change from baseline at 1 hour with 60 mcg dose was also met.