Business
BioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials
More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients On track to report topline data from both studies in
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients\n On track to report topline data from both studies in mid-2020 NEW HAVEN, Conn., March 19, 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 more than one-third of the patients in the Phase 3 SERENITY trials have been enrolled and treated. To date, the company has not observed a change in enrollment rates resulting from the COVID-19 pandemic, and currently maintains previous guidance that SERENITY I & II are expected to be completed by mid-year 2020. “Despite the current situation with COVID-19, we remain on track with the enrollment of our SERENITY studies,” stated Vimal Mehta, Chief Executive Officer of BTI. “Up to now, all schizophrenia and bipolar patients enrolled have successfully self-administered the BXCL501 treatment, guided by a healthcare provider, and the trials seem to be progressing well. We are optimistic that enrollment rates will continue to stay consistent with previous weeks and are looking forward to sharing topline results in the middle of this year.” 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 enrolling patients with agitation associated with schizophrenia, with each arm 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 NeuropsychologyAgitation 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 ...