BioXcel Therapeutics Announces Initiation of a Phase 2 Study Designed to Assess Agitation-Associated Biomarkers and their Response to BXCL501

Study aims to support BXCL501’s potential market expansion in chronic agitation disease conditions

Topline results expected in the second quarter of 2020

NEW HAVEN, Conn., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced the initiation of a Phase 2 study by researchers at Yale University designed to measure biomarkers associated with agitation in patients with schizophrenia and the response to treatment with BXCL501. The Company aims to utilize biomarkers to identify additional indications that exhibit the same physiological signals of hyperarousal, expanding the potential use of BXCL501 to new chronic disease indications.

“Building on the significant results from our Phase 1b trial in patients with agitation associated with schizophrenia, this study is designed to further confirm the calming capabilities of dexmedetomidine, the active ingredient in BXCL501, using an objective scale to measure signs of hyperarousal,” commented Dr. Frank Yocca, Chief Scientific Officer of BTI. “In an agitated state, there are physiological changes that may occur, including differences in heart rate, electrodermal activity and EEG (electroencephalography), which have the potential to be used as an initial signal for treatment with BXCL501. In addition, we believe these biomarkers may have relevance for the treatment of additional distinct chronic indications characterized by nervous system arousal, including Post-Traumatic Stress Disorder and alcohol withdrawal symptoms.”

“Managing agitation, a common symptom of neuropsychiatric conditions, is a burdensome challenge for both physicians and caregivers,” added Dr. John Krystal, M.D., Robert L. McNeil, Jr. Professor of Translational Research and Professor of Psychiatry and of Neuroscience; Co-Director, Yale Center for Clinical Investigation and Chair, Department of Psychiatry at Yale School of Medicine. “The ability to detect bodily signals that indicate an agitated state prior to the onset of visible symptoms could be extremely beneficial to caregivers. An early signal will allow for sufficient time to proactively treat the agitation before it becomes dangerous to the individuals involved.”