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BioXcel Therapeutics Initiates Pivotal Phase 3 Program of BXCL501 for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Two Phase 3 studies to enroll a total of 300 patients in assisted living or residential facilities and nursing homes to evaluate the safety and efficacy of
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Two Phase 3 studies to enroll a total of 300 patients in assisted living or residential facilities and nursing homes to evaluate the safety and efficacy of BXCL501 Studies designed to maximize BXCL501 opportunity to treat full spectrum of agitation, with an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually No FDA approved therapies for treatment of agitation associated with Alzheimer’s NEW HAVEN, Conn., Dec. 15, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the initiation of its pivotal Phase 3 program for BXCL501, the Company’s proprietary, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation in patients with Alzheimer’s disease (AD). The program’s two studies, TRANQUILITY II and TRANQUILITY III, are designed to evaluate the safety and efficacy of BXCL501 in adults 65 years and older in assisted living or residential facilities and nursing homes. \"We received FDA breakthrough therapy designation for BXCL501 in March 2021 based on our Phase 1b/2 TRANQUILITY study. Following multiple meetings with the FDA, we are pleased to announce the initiation of our Phase 3 program,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “This marks an important advancement in potentially bringing this novel treatment to the more than 4 million patients, who experience agitation as one of AD’s most devastating symptoms. We are leading the development path for this innovative therapy and are confident in BXCL501’s potential to treat acute, as well as intermittent, forms of agitation.” The program expands the evaluation of patients in diverse medical settings across the range of dementia severity. It is designed to maximize the opportunity of BXCL501 for the treatment of the full spectrum of agitation associated with AD. Pivotal Phase 3 Program Summary The program will consist of two randomized, placebo-controlled, adaptive, parallel group pivotal trials, TRANQUILITY II and TRANQUILITY III.Each study will enroll 150 dementia patients 65 years and older. Patients will self-administer 40 mcg or 60 mcg of BXCL501 or placebo whenever agitation episodes occur over ...