NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company known for its AI-driven drug development, announced a collaboration with the University of North Carolina at Chapel Hill to assess the effectiveness and safety of BXCL501. This investigational drug is being considered for the treatment of acute stress disorder (ASD), with funding support from the U.S. Department of Defense (DoD). The DoD has granted $2.8 million to the UNC Institute for Trauma Recovery for a study that will take place from September 15, 2024, to September 14, 2026.
The research will focus on BXCL501's potential to alleviate ASD symptoms, which can include anxiety, sleep disturbances, and concentration difficulties following a traumatic event. The double-blind, placebo-controlled trial is set to enroll 100 patients who have experienced ASD due to motor vehicle accidents, starting in the first half of 2025. BioXcel Therapeutics will supply the drug for the trial.
The need for effective ASD treatments is underscored by the estimated 40 million Americans who seek emergency department care annually after traumatic experiences. The UNC-led study aims to explore whether early administration of BXCL501 can reduce acute stress symptoms and prevent chronic neuropsychiatric issues.
BXCL501, also known as IGALMI™ (dexmedetomidine) sublingual film, is already approved by the U.S. Food and Drug Administration for certain uses and is under investigation for others, including the treatment of agitation related to bipolar disorder, schizophrenia, and Alzheimer’s dementia. It has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation related to schizophrenia, bipolar disorders, and dementia.
The company has also been involved in other government-supported trials for BXCL501, targeting post-traumatic stress disorder (PTSD) related to alcohol use disorder (AUD) and opioid use disorder (OUD), with studies being conducted by Yale University Medical School and Columbia University.
This press release contains forward-looking statements regarding the potential of BXCL501, and while the company believes in the promise of its product, actual results could vary. The information presented is based on a press release statement and does not necessarily reflect the views of the DoD.
In other recent news, BioXcel Therapeutics has undergone significant changes and advancements. The pharmaceutical company reported a Q2 revenue of $1.1 million, primarily from IGALMI sales, surpassing expectations. The firm also announced a strategic workforce reduction of 28%, affecting 15 employees, to prioritize the development of its leading neuroscience product, BXCL501. This decision comes alongside the departure of its Senior Vice President and Chief Commercial Officer, Matthew Wiley, who has transitioned to a consulting role.
BioXcel Therapeutics has initiated critical Phase 3 trials named SERENITY At-Home and TRANQUILITY In-Care, aiming to evaluate the safety and efficacy of BXCL501 for patients with bipolar disorders, schizophrenia, and Alzheimer's disease. Furthermore, the company has entered into a consulting agreement with Commercial Science, LLC, managed by Wiley, to provide consulting services until December 31, 2024.
On the analyst front, H.C. Wainwright and Canaccord Genuity have maintained their Buy ratings on BioXcel Therapeutics, while Mizuho Securities holds a neutral stance due to concerns about the company's financial health. These recent developments highlight BioXcel Therapeutics' ongoing research and development efforts and strategic direction.
InvestingPro Insights
As BioXcel Therapeutics embarks on this promising collaboration with UNC-Chapel Hill, backed by Department of Defense funding, investors should consider some key financial metrics and expert insights from InvestingPro.
According to InvestingPro data, BioXcel's market capitalization stands at $21.85 million, reflecting its current position in the biotech sector. The company has shown impressive revenue growth, with a 131.5% increase over the last twelve months as of Q2 2024. This growth trajectory aligns with the company's ongoing research and development efforts, including the BXCL501 trials.
However, it's important to note that BioXcel, like many early-stage biotech companies, is not yet profitable. An InvestingPro Tip highlights that analysts do not anticipate the company will be profitable this year. This is not uncommon for companies investing heavily in drug development and clinical trials.
Another InvestingPro Tip indicates that BioXcel is quickly burning through cash, which is a critical factor for investors to monitor, especially given the capital-intensive nature of pharmaceutical research. The company's ability to secure funding, such as the DoD grant for the ASD study, becomes particularly significant in this context.
For those seeking a more comprehensive analysis, InvestingPro offers 12 additional tips that could provide valuable insights into BioXcel's financial health and market position. These tips could be especially useful for investors looking to understand the company's potential in light of its ongoing clinical trials and collaborations.
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