NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a company specializing in the development of AI-driven neuroscience medicines, has announced significant clinical and regulatory milestones in its Phase 3 trials for BXCL501. This investigational drug is aimed at treating acute agitation in patients with bipolar disorders or schizophrenia, as well as those with Alzheimer’s dementia.
The SERENITY At-Home trial, which began on September 5, 2024, is evaluating the safety of a 120 mcg dose of BXCL501 for at-home use. The first patient in this double-blind, placebo-controlled, 12-week outpatient study has been randomized, with an estimated enrollment of around 200 patients.
Parallel to this, the TRANQUILITY In-Care trial is designed to assess the efficacy and safety of a 60 mcg dose for agitation associated with Alzheimer’s dementia (AAD) over a 12-week period. The study, which will include approximately 150 patients aged 55 and older in various care facilities, has received feedback from the U.S. Food and Drug Administration on its protocol.
BXCL501, already approved for use under healthcare provider supervision as IGALMI™ (dexmedetomidine sublingual film), could potentially expand its label with these trials to reach millions more patients by allowing at-home treatment for bipolar or schizophrenia-related agitation. For AAD, there is currently no U.S. regulatory precedent for episodic treatment, marking a unique opportunity for the drug's application.
Vincent O’Neill, M.D., Chief of Product Development and Medical (TASE:PMCN) Officer at BioXcel Therapeutics, expressed optimism about leveraging the company's clinical development experience to address these critical unmet medical needs.
IGALMI™ is indicated for the acute treatment of agitation in adults with schizophrenia and bipolar I or II disorder and is administered under the supervision of a healthcare provider. It has not been studied for use beyond 24 hours from the first dose, and its safety and efficacy in children are unknown.
The forward-looking statements in this press release are based on the company's current expectations and beliefs, which are subject to a number of risks and uncertainties that could cause actual results to differ materially. These include the company's limited operating history, need for substantial funding, and the challenges of drug development and commercialization.
This news is based on a press release statement from BioXcel Therapeutics.
In other recent news, BioXcel Therapeutics reported Q2 revenue of $1.1 million, primarily from IGALMI sales, exceeding expectations. The company also announced a strategic workforce reduction of 28%, impacting 15 employees, to focus on the development of its primary neuroscience product, BXCL501. Alongside these changes, Matthew Wiley, Senior Vice President and Chief Commercial Officer, transitioned to a consulting role. Additionally, BioXcel Therapeutics formed a partnership with the University of North Carolina at Chapel Hill to evaluate the effectiveness and safety of BXCL501 for acute stress disorder, with funding support from the U.S. Department of Defense. H.C. Wainwright and Canaccord Genuity maintained their Buy ratings on the company, despite lowering their price target, while Mizuho (NYSE:MFG) Securities adopted a neutral stance due to concerns about the company's financial health. These are recent developments for BioXcel Therapeutics.
InvestingPro Insights
As BioXcel Therapeutics (NASDAQ:BTAI) advances its clinical trials for BXCL501, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at $29.33 million, reflecting its current position in the biotech sector.
InvestingPro Data shows that BTAI's revenue growth has been impressive, with a 131.5% increase in the last twelve months as of Q2 2024. This aligns with the company's progress in clinical trials and potential market expansion for IGALMI™. However, it's important to note that despite this growth, the company is not yet profitable, with an operating income margin of -4353.35% in the same period.
Two relevant InvestingPro Tips for BTAI are:
1. Analysts anticipate sales growth in the current year, which is consistent with the company's ongoing clinical trials and potential label expansion for BXCL501.
2. The company is quickly burning through cash, a common characteristic for biotech firms in the development stage.
These insights are particularly relevant given BTAI's focus on expanding its drug applications and the significant investments required for clinical trials. Investors should weigh the potential for future revenue growth against the current cash burn rate.
For those interested in a deeper analysis, InvestingPro offers 9 additional tips for BTAI, providing a more comprehensive view of the company's financial health and market position.
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