BioXcel Therapeutics Starts Testing BXCL501 In Mid-Stage Delirium-Related Agitation Study

BioXcel Therapeutics Inc (NASDAQ: BTAI) initiated the Phase 2 PLACIDITY trial evaluating BXCL501 to treat delirium-related agitation.
The 20 subject-trial is designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium-related agitation, including COVID-19 patients.
The primary endpoint is reducing agitation measured by at least a 2-point drop in agitation scale at two hours post-BXCL501 administration.
The secondary endpoint is the earliest time at which a 2-point drop is seen after BXCL501 administration.
An exploratory endpoint of this trial will be to determine the overall clinical improvement after drug administration.
Topline results from the study expected in the first quarter of 2022.
BXCL501 is an orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms.
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