BXCL501 Led to Fast, Safe, Durable Drop in Agitation in Dementia Patients

BXCL501 Led to Fast, Safe, Durable Drop in Agitation in Dementia Patients
BXCL501, BioXcel Therapeutics’ experimental therapy for the treatment of agitation associated with dementia, was found to be well-tolerated and able to rapidly and sustainably lower agitation in patients with different forms of dementia, including Alzheimer’s disease. These top-line findings from TRANQUILITY, BioXcel's Phase 1b/2 clinical trial (NCT04251910), are expected to support the therapy’s continued development as a treatment for agitation associated with dementia. “We are very encouraged by the promising topline results from the TRANQUILITY study, which was designed to identify a recommended dose of BXCL501 for a potential pivotal study in dementia patients suffering from agitation,” Vimal Mehta, CEO of BioXcel, said in a press release. “Based on the results observed, we believe BXCL501 has broad potential in treating the full spectrum of agitation in patients with dementia. We look forward to advancing BXCL501 into a late-stage study this year following dialogue with the FDA,” Mehta said. A proprietary orally dissolving formulation of dexmedetomidine, BXCL501 is a selective agonist of alpha-2a adrenergic receptors with potent anti-anxyolitic and sedative properties. It is normally used to sedate patients undergoing invasive procedures or in intensive care settings. BXCL501 is easy to administer, and designed to rapidly trigger a calming effect, without causing excessive sedation. BioXcel also believes that BXCL501 potentially may cause fewer side effects than other antipsychotics currently used in clinical practice. The experimental therapy's safety and efficacy in treating acute agitation associated with different forms of dementia are currently being investigated in the randomized, dose-finding TRANQUILITY trial. It enro
Subscribe or to access all post and page content.