U.S. Department of Defense awarded $2.8 million to UNC Institute for Trauma Recovery researchers led by Samuel McLean, MD, to test the safety and efficacy of BXCL501 – sublingual dexmedetomidine created by BioXcel Therapautics for treating acute stress reaction symptoms and preventing posttraumatic stress.
Each year, about 40 million people in the United States are taken to hospital emergency departments after a traumatic experience, such as a car crash or sexual assault. In the days and weeks that follow, many of these millions of individuals experience acute stress reaction (ASR) symptoms, which include anxiety, sleep disturbance, concentration difficulty, pain, dizziness and lightheadedness. If these symptoms do not resolve, then posttraumatic neuropsychiatric symptoms can set in, such as persistent pain, posttraumatic stress, and depressive symptoms. These kinds of acute and chronic symptoms are also common in U.S. servicemen and women who experience severe stress during military deployment.
To address this major health problem, the UNC Institute for Trauma Recovery at the UNC School of Medicine will lead a clinical trial in collaboration with BioXel Therapuautics, a biopharmaceutical company that uses artificial intelligence in the development of transformative neuroscience medicines, to evaluate the efficacy and safety of BXCL501 – a new formulation of sublingual dexmedetomidine – to reduce acute stress reaction symptoms and prevent chronic symptoms.
The US Department of Defense has invested $2.8 million for this phase 2 clinical trial, led by principal investigator Samuel McLean, MD, MPH, director of the UNC Institute for Trauma Recovery and professor of psychiatry and emergency medicine at the UNC School of Medicine.
“There is an urgent need for effective interventions to prevent the development of these ‘invisible wounds,” McLean said. “Fortunately, advances in research methods and biologic understanding have created an opportunity to develop interventions to prevent symptoms associated with ASR. 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 transition to chronic symptoms.”
This double-blind, placebo-controlled trial is expected to enroll 100 patients experiencing ASR resulting from motor vehicle collisions, beginning in the first half of 2025. BioXcel Therapeutics will supply BXCL501 for the trial.
“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 the treatment of the spectrum of symptoms related to trauma and stress-related disorders,” said Frank Yocca, PhD, Chief Scientific Officer of BioXcel Therapeutics. “Our lead neuroscience asset is currently being evaluated by Yale University School of Medicine for the potential chronic 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.”
For this trial, participants will be prescribed BXCL501, an oral medicine that dissolves under the tongue and has been shown to be safe in the treatment of agitation as a result of other conditions. This is one of a number of medication and non-medication interventions being tested at the UNC Institute for Trauma Recovery to reduce acute stress reaction symptoms and prevent chronic symptoms. The goal is to create a new class of interventions that can reduce acute symptoms and prevent chronic posttraumatic stress and related disorders before they develop.
This ASR 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.
UNC School of Medicine contact: Mark Derewicz, director of research and national news