BioXcel Enrolls First Patients in 100-Subject DoW-Funded Phase 2a ASR Trial
BioXcel Therapeutics has enrolled the first patients in the U.S. Department of War-funded Phase 2a trial of BXCL501 sublingual dexmedetomidine for acute stress reactions at UNC, targeting 100 post-motor-vehicle-collision cases under a double-blind, placebo-controlled NCT06943404 protocol. Positive results could prompt VA/DoW guideline revisions to include pharmacological ASR treatment.
1. Enrollment Milestone
BioXcel Therapeutics has initiated patient dosing in a U.S. Department of War-funded Phase 2a study of BXCL501 at the University of North Carolina Institute for Trauma Recovery, marking the first enrollment in this collaboration. The award HT9425-24-1-1108 supports the trial’s conduct with 100 planned participants.
2. Trial Design and Objectives
The double-blind, placebo-controlled NCT06943404 trial will assess BXCL501’s ability to reduce acute stress reaction symptom severity, improve neurocognitive function, and prevent progression to chronic posttraumatic neuropsychiatric sequelae in individuals following motor vehicle collisions.
3. Potential Clinical and Guideline Impact
Current VA/DoW guidelines recommend trauma-focused psychotherapy over pharmacotherapy for ASR; a positive outcome could establish dexmedetomidine as the first approved drug treatment pathway, expanding BioXcel’s pipeline-in-a-product strategy and enhancing its clinical footprint.