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BioXcel Therapeutics Announces Completion of Patient Enrollment in Phase 3 SERENITY Trials with BXCL501
Topline results, expected in July of 2020, are intended to support a New Drug Application filing NEW HAVEN, Conn., May 14, 2020 (GLOBE NEWSWIRE) -- BioXcel
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Topline results, expected in July of 2020, are intended to support a New Drug Application filing\nNEW HAVEN, Conn., May 14, 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 full enrollment of its pivotal Phase 3 SERENITY trials evaluating BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. The Company expects to report topline data from both trials in July of 2020.\n “Completing patient enrollment in our two Phase 3 studies marks a significant milestone for BTI, and lays the foundation for future growth as we look to pursue clinical trials for several additional indications for BXCL501,” commented Vimal Mehta, Ph.D., Chief Executive Officer of BTAI. “The BTI team has remained focused, with our clinical programs on track despite the ongoing COVID-19 pandemic. We’re looking forward to reporting results from the two SERENITY registration trials, which we expect will be in July, to be followed by a potential New Drug Application submission in early 2021.” The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients, 18 to 75 years of age. SERENITY I is evaluating patients with agitation associated with schizophrenia, with each of three arms receiving BXCL501 at 120 micrograms, 180 micrograms or placebo, respectively. SERENITY II is evaluating patients with agitation associated with bipolar disorder, also in three arms, receiving BXCL501 at 120 micrograms, 180 micrograms or placebo, respectively. The primary endpoint of the trials is reducing acute agitation measured by the Positive and Negative Syndrome Scale, examining the Excited Component (“PEC”) change from baseline compared to placebo. A key secondary endpoint includes determining the earliest time where an effect on agitation is apparent as measured by the change from baseline in PEC total score. About Agitation in Neuropsychology Agitation is a common and difficult to manage symptom associated with a number of psychiatric conditions, including schizophrenia and bipolar disorder. It is estimated that approximately 19 million people are at risk of agitation, and 8.3 million in the U.S. ...