BioXcel Therapeutics Announces First Patient Dosed in TRANQUILITY III Phase 3 Trial for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
NEW HAVEN, Conn., Dec. 19, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 (dexmedetomidine) sublingual film, the Company’s proprietary, orally dissolving film, under investigation for the acute treatment of agitation in patients with Alzheimer’s disease (AD). AD is the most prevalent type of dementia in the U.S.5 The TRANQUILITY program includes two investigational studies, TRANQUILITY II and TRANQUILITY III, which are designed to evaluate the safety and efficacy of BXCL501 for the acute treatment of Alzheimer’s-associated agitation in adults 65 years and older in assisted living or residential care facilities and nursing homes.
- “The prevalence of Alzheimer’s disease is unfortunately increasing and there remains no FDA-approved product indicated for patients experiencing agitation associated with this condition,” said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics.
- This potential opportunity is in addition to the current acute treatment of agitation associated with schizophrenia or bipolar I or II disorder market opportunity.
- TRANQUILITY II will assess patients in assisted living or residential care facilities requiring minimal assistance with activities of daily living.
- TRANQUILITY III will assess patients residing predominantly in nursing homes with moderate to severe dementia who require moderate or greater assistance with activities of daily living.