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BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with Delirium
Fifth potential indication for BXCL501, an orally dissolving thin film NEW HAVEN, Conn., Oct. 26, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Fifth potential indication for BXCL501, an orally dissolving thin film\nNEW HAVEN, Conn., Oct. 26, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced that its Investigational New Drug (“IND”) application for BXCL501, the Company’s novel, proprietary, orally dissolving, sublingual thin film formulation of dexmedetomidine (“Dex”), has received clearance by the Division of Psychiatry Products at the U.S. Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. The Company plans to initiate a Phase 2 trial within the next several months.\n “We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI. “Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. We believe that BXCL501’s unique mechanism of action, rapid onset, and ease of administration may quickly and directly treat the underlying agitation without over sedation, improving patient outcomes. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.” This trial is a multicenter, randomized, double-blind, placebo-controlled, ascending, dose-finding, adaptive Phase 2 study designed to evaluate the safety, pharmacokinetics and efficacy of BXCL501 in intensive care unit patients experiencing agitation associated with delirium, including COVID-19 patients. Approximately 20 patients will be randomized into each sequential ascending dose cohort of BXCL501 (starting doses of 120 ug, 180 ug, 240 ug, or 300 ug), or matching placebos to determine the optimal starting dose that effectively and safely reduces agitation. Elderly delirium patients (65 years or older) in these cohorts will receive half the dose....