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BioXcel Therapeutics Announces Positive Top-Line Data from Repeat Dosing of BXCL501 in Phase 1b Multiple Ascending Dose Trial in Healthy Volunteers for Major Depressive Disorder (MDD) Program
BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically Planning Phase 2 human proof-of-concept study to evaluate
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically Planning Phase 2 human proof-of-concept study to evaluate BXCL501 as a potential adjunctive treatment in MDD Data further supportive of ongoing clinical programs evaluating BXCL501 for potential at-home use for agitation associated with schizophrenia or bipolar disorders (SERENITY III) and agitation associated with Alzheimer’s disease (TRANQUILITY II and III) NEW HAVEN, Conn., May 16, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced positive top-line data from its Phase 1b multiple ascending dose (MAD) trial of BXCL501 (dexmedetomidine) sublingual film. BXCL501 is the Company’s proprietary, orally dissolving film under investigation for the treatment of agitation associated with neuropsychiatric disorders and as a potential adjunctive treatment in Major Depressive Disorder (MDD). The trial was designed to evaluate the safety and tolerability of repeat dosing of BXCL501 in healthy volunteers as a single agent and in combination with antidepressant duloxetine. These results support dose selection for a Phase 2 proof-of-concept (POC) trial to evaluate BXCL501 in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitor (SNRIs) to potentially accelerate antidepressant activity in patients with MDD. “This positive outcome supports the potential market expansion opportunity for our lead asset, BXCL501, into chronic neuropsychiatric disorders,” said Vimal Mehta, CEO of BioXcel Therapeutics. “Our focus has been on developing innovative treatments for the millions of patients who are impacted by agitation episodes, including Alzheimer’s disease. Our first drug, IGALMI™, is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. We believe these new data present a transformative opportunity beyond acute treatment for the BXCL501 program, including treatment for MDD. This drug candidate has a pipeline-within-a-product potential across a broad range of neuropsychiatric conditions.” The study was a double-blind, placebo-controlled evaluation of BXCL501 for...