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BioXcel Therapeutics Announces First Patient Enrolled in Phase 1b/2 Study of BXCL501 for Acute Treatment of Agitation Associated with Dementia
Foundational study with plans to address multiple types of agitation associated with dementia Expands the potential therapeutic use of BXCL501 beyond
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":" Foundational study with plans to address multiple types of agitation associated with dementia\n Expands the potential therapeutic use of BXCL501 beyond neuropsychiatric disorders Topline results expected in mid-2020 NEW HAVEN, Conn., Jan. 07, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced that the first patient has been enrolled in a Phase 1b/2 study of BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”), for the acute treatment of agitation in patients with dementia. “We are excited to advance the clinical development of BXCL501 in agitation associated with dementia, a third potential indication for our lead product candidate,” commented Robert Risinger, M.D., Vice President, Clinical Development of BTAI. “With no approved treatments, there is a significant need for better treatment options for the 6 million patients in the U.S. with dementia, many of whom will experience agitation during the course of their disease. We believe our candidate, BXCL501, with its unique mechanism and convenient oral dosing, has the potential to rapidly reduce agitation associated with dementia without excessive sedation or other undesired side effects. This study builds upon the foundation for a broad BXCL501 program in dementia, including the treatment of chronic agitation and the prevention of agitation using a wearable device in combination with BXCL501.” The multicenter, randomized, double-blind, placebo-controlled, ascending dose Phase 1b/2 study is designed to evaluate the efficacy, pharmacokinetics, safety and tolerability of BXCL501 in adults 65 years and older who exhibit acute agitation associated with all forms of dementia, including Alzheimer's disease. The dementia program expands on the Phase 1b study performed with BXCL501 in 135 patients with agitation associated with schizophrenia, and also builds on the positive results observed in reducing agitation with intravenous Dex in Alzheimer’s disease patients. This is an adaptive design and is expected to assess multiple dose cohorts of BXCL501 or matching placebos. Following the completion of each dose cohort, a safety...