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BioXcel Therapeutics Provides Update on its BXCL501 Program for the Acute Treatment of Dementia Related Agitation
Review of TRANQUILITY data showed 30 mcg dose met statistical significance across multiple scales Company initiated supplemental 40 mcg dose cohort to help
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Review of TRANQUILITY data showed 30 mcg dose met statistical significance across multiple scales Company initiated supplemental 40 mcg dose cohort to help inform clinical development strategy across the full range of dementia care settings End of Phase 2 meeting scheduled with U.S. Food and Drug Administration (“FDA”) in Q2 2021 Pivotal Phase 3 program expected to begin in the second half of 2021 NEW HAVEN, Conn., March 03, 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 an update to its BXCL501 dementia program, including clinical updates and the scheduling of its end of Phase 2 meeting with the FDA. BXCL501 is the Company’s investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (“Dex”). Following the end of Phase 2 meeting with the FDA, the Company plans to finalize study design, dosing, and endpoints for its Phase 3 registrational program that is expected to begin in the second half of 2021. As part of its overall clinical development strategy aimed at addressing the broadest dementia related agitation market, the Company is also providing an update on the TRANQUILITY clinical results, as well as announcing initiation of a supplemental study to evaluate a 40 mcg dose: In January 2021, BioXcel announced that the 60 mcg dose of BXCL501 met the primary and all secondary endpoints in the TRANQUILITY Phase 1b/2 study for the acute treatment of dementia related agitation, demonstrating statistically significant, clinically meaningful, rapid, and durable reductions in agitation with no severe or serious adverse events. The Company also reported that a lower 30 mcg dose showed numerical improvements compared to placebo. Following a routine quality control review of the Company’s TRANQUILITY study data, the Company discovered that two patients were mis-categorized within the 30 mcg cohort at the clinical site. After moving the two patients into their appropriate placebo and 30 mcg groups, the data from the 30 mcg cohort were re-analyzed, resulting in the 30 mcg dose crossing over to statistical significance at the two hour time point, as measured by PEC: p=0.0149; PAS: p=0.0195;...