BioXcel Therapeutics to Present at 2024 ASCP Annual Meeting

May 21, 2024 – BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical firm leveraging artificial intelligence to create transformative therapies in neuroscience and immuno-oncology, has announced the participation of Rob Risinger, M.D., Chief Medical Officer of Neuroscience, in the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The conference will be held from May 28 to 31, 2024, in Miami Beach, FL.

Dr. Risinger will be presenting both orally and through posters during the event. 

The oral presentation, titled “An Exploratory Comparison of Sublingual Dexmedetomidine with Quetiapine in Healthy Elderly Subjects,” is scheduled for May 28, 2024, from 2:20-2:30 p.m. ET in Salon 3. 

The first poster presentation, “Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of BXCL501 with Concomitant Treatment with Anti-Depressant in Healthy Volunteers,” will take place on May 29, 2024, from 11:15 a.m. to 1:00 p.m. ET in Salon 4. 

The second poster, titled “A Phase Ib/II Multicenter, Randomized, Double Blind, Placebo-Controlled, Ascending Dose Finding Study of BXCL501 in Agitation Associated with Dementia,” will be presented on May 30, 2024, between 12:30 and 2:15 p.m. ET, also in Salon 4.

BXCL501 is an investigational, proprietary, orally dissolving film formulation of dexmedetomidine, which is a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics posits that BXCL501 has the potential to address significant mediators of agitation, with observed positive results in numerous clinical trials across various neuropsychiatric disorders. The drug is currently under investigation for the treatment of acute agitation in dementia due to probable Alzheimer's disease, as well as agitation associated with bipolar I or II disorder or schizophrenia in home settings. It is important to note that the safety and efficacy of BXCL501 for these investigational uses have not yet been confirmed. However, the FDA has granted BXCL501 Breakthrough Therapy designation for acute treatment of agitation associated with dementia and Fast Track designation for acute agitation associated with schizophrenia, bipolar disorders, and dementia.

IGALMI™ (dexmedetomidine) sublingual film is a prescription medication used under medical supervision for the acute treatment of agitation linked to schizophrenia and bipolar disorder I or II in adults. The safety and efficacy of IGALMI have not been established for use beyond 24 hours from the first dose, and its safety and efficacy in children remain unstudied.

Patients using IGALMI should be aware of possible serious side effects such as decreased blood pressure, low blood pressure upon standing, slower heart rate, and changes in heart rhythm. These effects are particularly significant in patients with conditions like low blood volume, diabetes, chronic high blood pressure, or older patients. After administration, patients should be monitored by a healthcare provider to prevent falls or fainting, and they should stay hydrated and avoid activities requiring mental alertness, such as driving, for at least eight hours post-administration.

Common side effects reported in clinical studies include sleepiness or drowsiness, mouth sensations such as tingling or numbness, dizziness, dry mouth, and low blood pressure. Patients should consult their healthcare provider for medical advice about these side effects and should disclose their full medical history, including any heart conditions, electrolyte imbalances, blood pressure issues, diabetes, history of fainting, or liver impairment. Women who are pregnant or breastfeeding should also inform their healthcare provider.

BioXcel Therapeutics, Inc. is a biopharmaceutical company using artificial intelligence to develop innovative drugs in neuroscience. Its subsidiary, OnkosXcel Therapeutics, focuses on immuno-oncology treatments. By re-innovating existing drugs and using big data and machine learning algorithms, BioXcel aims to identify new therapeutic indications.

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