BioXcel Therapeutics Announces Presentations at the ISBD 2021 Global Annual Conference

Rhea-AI Summary

BioXcel Therapeutics (BTAI) announced the selection of four abstracts for presentation at the ISBD 2021 Global Annual Conference from May 13-15, 2021. Key topics include the pivotal SERENITY program results on BXCL501's efficacy in treating acute agitation in bipolar disorder. The company has also submitted a New Drug Application for BXCL501 to the FDA. This innovative formulation targets agitation mechanisms and has received breakthrough designations, emphasizing its potential in neuropsychiatric treatment.

Positive

• Four abstracts highlighting BXCL501's effectiveness presented at ISBD 2021.
• Submission of New Drug Application for BXCL501 to FDA.
• Breakthrough Therapy designation for treating agitation associated with dementia.

Negative

• None.

NEW HAVEN, Conn., May 11, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that four abstracts were selected for presentation at the International Society for Bipolar Disorders (“ISBD”) 2021 Global Annual Conference, which will take place virtually from May 13-15, 2021.

Among the presentations are results from the pivotal SERENITY program, further examining the effects of BXCL501 on acute agitation in bipolar disorder across mood states, as well as an analysis of patient acceptance of the film formulation in terms of taste, aftertaste, smell and dissolve time.

The abstracts are currently available on the ISBD website at isbd2021.org. At the start of the poster sessions, the posters will be available in the “News & Media” section of the Company’s website at www.bioxceltherapeutics.com.

POSTER PRESENTATION DETAILS

Title: Effect of BXCL501 for Treating Acute Agitation in Patients with Bipolar Disorder Date/Time: Saturday, May 15, 2021 at 5:00-6:30 PM Eastern Time (Poster Session II)

Title: BXCL501 Demonstrates Significant Reduction in Agitation across All Mood States (depressed, hypomanic, manic) in Patients with Bipolar Disorder
Date/Time: Saturday, May 15, 2021 at 5:00-6:30 PM Eastern Time (Poster Session II)

Title: Pharmacokinetics of Dexmedetomidine after a Single Sublingual Dose of BXCL501 in Patients with Agitation Associated with Schizophrenia
Date/Time: Saturday, May 15, 2021 at 5:00-6:30 PM Eastern Time (Poster Session II)

Title: Safety and Patient Acceptability of BXCL501 for Treating Acute Agitation in Patients with Bipolar Disorder
Date/Time: Friday, May 14, 2021 at 5:00-6:30 PM Eastern Time (Poster Session I)

About BXCL501

BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. BioXcel believes that BXCL501 potentially targets a causal agitation mechanism, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders, including schizophrenia related agitation (SERENITY I), bipolar disorder related agitation (SERENITY II) and dementia related agitation (TRANQUILITY). BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders and dementia. The Company recently submitted its New Drug Application to the FDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders. The safety and efficacy of BXCL501 has not been established.

About BioXcel Therapeutics, Inc.:

BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. BioXcel’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BioXcel’s two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.

Contact Information:

BioXcel Therapeutics, Inc.

www.bioxceltherapeutics.com

Investor Relations:

Mary Coleman
BioXcel Therapeutics, VP of Investment Relations
MColeman@bioxceltherapeutics.com
1.475.238.6837

John Graziano
Solebury Trout
jgraziano@soleburytrout.com
1.646.378.2942

Media:

Julia Deutsch
Solebury Trout
jdeutsch@soleburytrout.com 
1.646.378.2967

FAQ

What abstracts did BioXcel submit for the ISBD 2021 Conference?

BioXcel submitted four abstracts focusing on BXCL501's treatment of acute agitation in bipolar disorder.

When is BioXcel's BXCL501 presentation at the ISBD 2021 Conference?

BXCL501's presentation is scheduled for May 15, 2021, during Poster Session II.

What is BXCL501 used for?

BXCL501 is an investigational drug aimed at treating agitation and opioid withdrawal symptoms.

What designations has BXCL501 received?

BXCL501 has received Breakthrough Therapy and Fast Track designations for its treatment applications.