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BioXcel Therapeutics Prepares to Initiate Pivotal Phase 3 Studies with BXCL501 Following Positive End-of-Phase 2 Meeting with FDA
The Company plans to initiate the pivotal studies by year end, with topline data reported mid-2020 The first sublingual, non-invasive acute treatment
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"The Company plans to initiate the pivotal studies by year end, with topline data reported mid-2020\n The first sublingual, non-invasive acute treatment candidate designed for agitation in neuropsychiatric diseases NEW HAVEN, Conn., Dec. 03, 2019 (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 it has reached a general agreement with the U.S. Food and Drug Administration (FDA) on the key elements of the designs for its SERENITY (Sub-Lingual DExmedetomidine in Agitation Associated With SchizophRENIa and Bipolar Disorder STudY) program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. Following the successful completion of its end-of-phase 2 meeting with the FDA, the Company plans to initiate the SERENITY studies by year end, with available topline results expected in mid-2020. “Our pivotal Phase 3 studies are designed to support the regulatory approval of BXCL501 as a non-injectable, acute treatment for agitation in patients with schizophrenia and bipolar disorder,” commented Vimal Mehta, Chief Executive Officer of BTI. “There is significant need for an easy-to-use, safe and fast acting therapy for the 8 million people in the U.S. that suffer from agitation associated with neuropsychiatric diseases. We’re highly encouraged by our interactions with the FDA, and are one step closer to providing physicians with a potentially more effective and easier-to-use therapy to help safely manage their patients.” The SERENITY studies closely follow the Company’s successful Phase 1b trial in 135 schizophrenia patients, where there were statistically significant, clinically meaningful rapid and durable reductions in PEC score at 120 and 180 microgram doses and acceptable safety profile. For the Phase 3 program, which will take place in many of the centers that participated in the Phase 1b trial, there will be two randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients 18 to 75 years of age. SERENITY I will enroll patients with agitation associated with schizophrenia, with each arm receiving either BXCL501 at 120 micrograms, 180 ...