Phase 2a efficacy and safety trial enrollment initiation expected in H1 2025
~40 million Americans go to emergency department annually after a traumatic experience 1
Second externally funded stress-related trial for BXCL501
NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced a collaboration with the University of North Carolina at Chapel Hill (UNC) on a grant awarded by the U.S. Department of Defense (DoD) to evaluate the efficacy and safety of BXCL501 as a potential treatment for acute stress disorder (ASD).
The award provides $2.8 million to the UNC Institute for Trauma Recovery from September 15, 2024 through September 14, 2026 to evaluate the potential efficacy of BXCL501 to reduce ASD symptom severity and/or posttraumatic neuropsychiatric symptoms. The double-blind, placebo-controlled trial is expected to enroll 100 patients experiencing ASD resulting from motor vehicle collisions, beginning in the first half of 2025. BioXcel Therapeutics will supply BXCL501 for the trial.
ASD symptoms occur in the days and weeks after trauma, and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms such as dizziness and lightheadedness. Chronic adverse posttraumatic neuropsychiatric symptoms occur when acute stress reaction does not resolve, and include persistent pain, posttraumatic stress, and depressive symptoms. ASD prevalence varies considerably based on the study and nature of the trauma. An estimated 40 million Americans annually go to the emergency department after a traumatic experience.1
"There is an urgent need for effective interventions to prevent the development of these ‘invisible wounds,'" said Principal Investigator Samuel McLean, M.D., MPH, Professor of Psychiatry and Emergency Medicine and Director of the Institute for Trauma Recovery at the UNC School of Medicine. "Fortunately, advances in research methods and biologic understanding have created an opportunity to develop interventions to prevent symptoms associated with ASD. We look forward to initiating this important study of BXCL501, which could potentially be administered to patients in the early aftermath of severe trauma to reduce acute stress symptoms and prevent the emergence of chronic symptoms."
"In addition to our development of PRN dosing treatment with BXCL501 for agitation associated with bipolar disorders, schizophrenia, and Alzheimer's dementia, BXCL501 may have potential as a precision medicine for short-term treatment of the spectrum of symptoms related to trauma and stress-related disorders," said Frank Yocca, Ph.D., Chief Scientific Officer of BioXcel Therapeutics. "Our lead neuroscience asset is currently being evaluated by Yale University School of Medicine for the potential short-term treatment of PTSD related to alcohol and substance abuse disorder, and we are pleased that a second externally funded trial will soon commence led by another prominent academic research institution."
The ASD research is supported by the DoD under award number HT9425-24-1-1108. The content presented in this release is solely the responsibility of the authors and does not necessarily represent the official views of the DoD.
About BXCL501 Government-Supported Investigator-Initiated Trials In addition ...
