Benzinga | Feb 25, 2021 11:46AM EST

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.

* Price Action: BTAI is up 1.3% at $57.72 in market trading hours on the last check Thursday.