BioXcel Therapeutics, Inc. (BTAI) has enrolled the first patients in a U.S. Department of War-funded phase 2a study evaluating BXCL501, its sublingual dexmedtomidine film, for the treatment of acute stress reactions. Acute stress reactions can occur in the days and weeks following traumatic events such as motor vehicle collisions, combat exposure, shootings, or natural disasters. Symptoms may include anxiety, sleep problems, difficulty concentrating, pain, dizziness, and other physical or emotional responses. If untreated, ASR can progress into long-term post-traumatic symptoms, including PTSD and depression.
The double-blind, placebo-controlled Phase 2a trial, led by the University of North Carolina's Institute of Trauma Recovery, aims to enroll 100 patients who experience ASRs after motor vehicle collisions. The study will evaluate whether BXCL501 can reduce symptom severity, improve neurocognitive function, and prevent progression to chronic post-traumatic neuropsychiatric symptoms. BioXcel is supplying the study drug.
ASRs are common among service members, first responders, and civilians exposed to trauma, affecting more than 40 million Americans who seek emergency care each year. Current VA/Department of War guidelines do not recommend medication. A positive outcome from this trial could help inform future updates to those guidelines.
UNC's principal investigator, Dr. Samuel McLean, said treating ASRs is an urgent military priority and highlighted the need for effective options for both service members and civilians. BioXcel CEO Vimal Mehta added that the study could support BXCL501's potential as a "pipeline-in-a-product" for multiple neuropsychiatric conditions.
BXCL501 is an investigational, orally dissolving film formulation of dexmedetomidine. Outside this study, it is FDA-approved as IGALMI for the acute treatment of agitation associated with bipolar disorder or schizophrenia in supervised medical settings.
BTAI has traded between $1.06 and $8.08 over the past year. The stock closed Tuesday's trading at $1.09, down 4.39%. In pre-market trading the stock is at $1.17, up 8%.
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