BioXcel Therapeutics, Inc. Begins Enrollment In DoW-Funded Phase 2a Trial Of BXCL501 For Acute Stress Reactions After Trauma

BioXcel Therapeutics, Inc., a biopharmaceutical company leveraging artificial intelligence to develop innovative neuroscience medicines, announced that the first patients have been enrolled in a U.S. Department of War (DoW)-funded Phase 2a clinical trial evaluating BXCL501 (sublingual dexmedetomidine) for the treatment of acute stress reactions (ASR), also referred to as acute stress disorder (ASD). The study is being conducted in collaboration with the University of North Carolina at Chapel Hill’s Institute for Trauma Recovery, marking an important milestone in the ongoing partnership between BioXcel Therapeutics and UNC.

The Phase 2a study (NCT06943404) is a randomized, double-blind, placebo-controlled trial designed to enroll approximately 100 patients who experience acute stress reactions following motor vehicle collisions. The trial will assess whether BXCL501 can reduce the severity of ASR symptoms, improve neurocognitive performance and help prevent the development of longer-term post-traumatic neuropsychiatric conditions. BioXcel Therapeutics is providing BXCL501 for use in the study.

Acute stress reactions typically occur in the days and weeks following a traumatic event and may include symptoms such as anxiety, sleep disturbances, difficulty concentrating, physical pain and somatic complaints like dizziness or lightheadedness. If these symptoms persist or fail to resolve, they can progress into chronic post-traumatic neuropsychiatric conditions, including post-traumatic stress disorder, ongoing pain syndromes and depressive symptoms. 

These reactions are common among military personnel, first responders, law enforcement officers and civilians exposed to traumatic events such as accidents, violence or natural disasters. It is estimated that tens of millions of individuals in the United States seek emergency care each year following trauma exposure, many of whom may experience acute stress-related symptoms.

Samuel McLean, M.D., MPH, Professor of Psychiatry and Emergency Medicine and Director of the Institute for Trauma Recovery at the University of North Carolina School of Medicine, who serves as Principal Investigator of the study, stated that addressing acute stress reactions is an urgent priority, particularly for service members and civilians exposed to traumatic events. He noted that the trial will evaluate BXCL501 as a potential therapeutic option to address a major unmet medical need in this patient population.

Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics, expressed support for the collaboration with UNC and emphasized the importance of the study in evaluating BXCL501 for acute stress reactions. He noted that the results could provide meaningful clinical benefit and further support the development of BXCL501 as a “pipeline-in-a-product” with broader therapeutic potential across neuroscience indications.

Current clinical guidelines from the 2023 VA/Department of War recommendations for the management of PTSD and ASR prioritize trauma-focused psychotherapies, particularly cognitive behavioral therapy, as first-line treatment approaches for acute stress reactions and prevention of post-traumatic stress disorder. Pharmacological interventions are generally not recommended for ASR, and benzodiazepines are discouraged. As a result, positive outcomes from this study could potentially contribute to future reassessment of treatment approaches and help establish a pharmacologic option for patients with acute and urgent treatment needs.

The ASR research program is supported by the U.S. Department of War under award number HT9425-24-1-1108. The company noted that the content of the study and related findings are the responsibility of the investigators and do not necessarily represent official views of the Department of War.