BioXcel Therapeutics to Speak at Jefferies Global Healthcare Conference

BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company employing artificial intelligence to advance treatments in neuroscience and immuno-oncology, has announced a significant presentation at the Jefferies Global Healthcare Conference in New York City. Scheduled for June 5 at 3 p.m. ET, CEO Vimal Mehta, Ph.D., along with Executive Vice President Vincent J. O’Neill, M.D., will discuss the company's late-stage clinical efforts with BXCL501. This drug is being developed for the urgent management of agitation associated with Alzheimer’s dementia, bipolar disorders, and schizophrenia.

BXCL501 is an investigational sublingual film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. This formulation is under study for its potential to treat acute agitation in patients with Alzheimer’s dementia, bipolar I or II disorder, or schizophrenia, particularly in home settings. Despite its promising potential, the safety and efficacy of BXCL501 for these uses have not been conclusively established. The drug has received Breakthrough Therapy designation for the treatment of agitation in dementia and Fast Track designation for agitation related to schizophrenia, bipolar disorders, and dementia from the FDA.

Dexmedetomidine, marketed as IGALMI™ for sublingual use, is a prescription medication for managing acute agitation in adults with schizophrenia and bipolar disorder I or II. IGALMI is administered under healthcare supervision, typically placed under the tongue or behind the lower lip. Its use has been studied for up to 24 hours following the first dose, and its safety and efficacy in children remain unknown.

Critical safety information for IGALMI includes potential side effects such as decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, especially in patients with certain pre-existing conditions. Heart rhythm changes, including QT interval prolongation, can occur, and patients with a history of abnormal heart rhythms should avoid IGALMI. The medication can also cause drowsiness, requiring patients to avoid activities that demand mental alertness for at least eight hours post-administration.

Other common side effects observed in clinical studies include sleepiness, dry mouth, dizziness, and low blood pressure. Patients are advised to inform their healthcare providers of their complete medical history, including any heart issues, low potassium or magnesium levels, diabetes, history of fainting, or liver impairment. Pregnant or breastfeeding women and those taking any other medications should also consult their healthcare providers before using IGALMI.

BioXcel Therapeutics is a company leveraging artificial intelligence to create transformative medicines in neuroscience. Its subsidiary, OnkosXcel Therapeutics, focuses on developing treatments in immuno-oncology. BioXcel's strategy involves re-innovating approved drugs and clinically validated candidates through big data and machine learning to discover new therapeutic uses.

The company emphasizes that forward-looking statements in their press release, including those related to participation in the Jefferies Global Healthcare Conference, are based on current expectations and assumptions. These statements are subject to various risks and uncertainties, such as the company's limited operating history, significant losses, need for additional funding, and dependence on the success of its key products like IGALMI and BXCL501.

BioXcel Therapeutics encourages reporting adverse effects of prescription drugs to the FDA and provides its own contact for direct reporting. Further details and updates can be found on their website.

In summary, BioXcel Therapeutics is advancing its clinical program with BXCL501 and IGALMI, focusing on treating acute agitation in various neuropsychiatric conditions. The company's innovative approach harnesses artificial intelligence to improve and repurpose existing therapeutic compounds, with ongoing research and regulatory efforts to bring these solutions to patients in need.