BioXcel Therapeutics announces first participant dosed in its TRANQUILITY II Phase III Trial for agitation in AD


On 3 May, BioXcel Therapeutics, a commercial-stage biopharmaceutical company utilising artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, announced that the first participant has been dosed in its TRANQUILITY II study for agitation in people with Alzheimer disease (AD). Initiated in December 2021, TRANQUILITY II and III are two pivotal Phase III trials evaluating BXCL501 for the acute treatment of agitation in people with AD. BXCL501 is an orally dissolving thin film formulation of dexmedetomidine. Each trial will enrol approximately 150 participants 65 years and older in assisted living or residential facilities and nursing homes. They will self-administer BXCL501 or placebo whenever agitation episodes occur over a three-month period. The studies will assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and Pittsburgh Agitation Scale (PAS) total scores.