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BioXcel Therapeutics Collaborates with University of North Carolina to Evaluate BXCL501 Grant from U.S. Department of Defense

Oct 15, 2024over 1 year ago

Contract Type

partnership

New Haven

Description

BioXcel Therapeutics, Inc. has announced a collaboration with the University of North Carolina at Chapel Hill to evaluate the efficacy and safety of BXCL501 as a potential treatment for acute stress disorder (ASD) through a grant awarded by the U.S. Department of Defense. The $2.8 million grant will fund a double-blind, placebo-controlled trial expected to enroll 100 patients experiencing ASD resulting from motor vehicle collisions, beginning in the first half of 2025.

Company Information

Company

Bio Xcel Therapeutics

Location

New Haven, Kentucky, United States

About

“The Company has an exciting, AI-driven approach to drug discovery and development, and we look forward to funding the expansion of these efforts and assisting the Company in bringing new, innovative therapies to patients worldwide.” The company is also developing BXCL502 as a potential therapy for chronic agitation in dementia, and BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. The firm emphasizes an opportunistic, value-oriented and risk-controlled approach to investments in credit, private equity, real assets and listed equities. The firm has over 1,000 employees and offices in 20 cities worldwide. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: the Company’s need for substantial additional funding and ability to raise capital when needed; the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming, expensive and inherently unpredictable; the Company has limited experience in drug discovery and drug development; regulatory agencies, may not accept or agree with the Company’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the Company in general; the Company has no experience in marketing and selling drug products and has not entered into arrangements for the sale and marketing of IGALMI or BXCL501; IGALMI or the Company’s other product candidates may not be accepted by physicians or the medical community in general; the Company may not be able to obtain marketing approvals for BXCL501 in Europe or other jurisdictions; the Company may need substantial additional funding to develop and conduct clinical trials with respect to its product candidates and support its operations; the Company must comply with extensive regulations applicable to it; and healthcare reform could adversely impact future commercial success. Under the agreement, BioXcel Therapeutics will receive $100 million in the first tranches of the strategic financing following approval by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) in respect of the use of the Company’s BXCL501 product for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology.

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