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

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  • BioXcel Therapeutics Inc (NASDAQ: BTAIinitiated 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.
 

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Posted-In: Covid-19 delirium-related agitation Phase 2 TrialBiotech News Small Cap FDA General

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