BioXcel Therapeutics Inc. (NASDAQ: BTAI) announced that the first patients have enrolled in a U.S. Department of War-funded Phase 2a clinical trial evaluating BXCL501 for treating acute stress reactions. The University of North Carolina at Chapel Hill Institute for Trauma Recovery leads the study.

The double-blind, placebo-controlled trial plans to enroll 100 patients experiencing acute stress reactions following motor vehicle collisions. The study will evaluate whether BXCL501, a sublingual dexmedetomidine formulation, can reduce symptom severity, improve neurocognitive function, and prevent progression to chronic posttraumatic neuropsychiatric symptoms.

Acute stress reactions occur in the days and weeks after trauma and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms. The condition affects more than 40 million Americans who seek emergency department care annually after traumatic stress exposure, according to the company.

"Supporting service men and women resilience and effectively treating ASRs is an urgent military priority," said Samuel McLean, the study's principal investigator and director of UNC's Institute for Trauma Recovery.

Current 2023 VA/DoW Clinical Practice Guidelines recommend trauma-focused psychotherapy as the primary treatment for acute stress reactions and generally do not recommend pharmacotherapy. Benzodiazepines are contraindicated for this condition.

The Department of War supports the research under award number HT9425-24-1-1108. BioXcel Therapeutics is supplying BXCL501 for the trial. The drug is currently approved by the FDA as IGALMI for treating agitation associated with schizophrenia or bipolar I or II disorder in adults.