Bioxcel therapeutics, inc. prepares to initiate pivotal phase 3 studies with bxcl501 following positive end-of-phase 2 meeting with fda
Bioxcel therapeutics, inc. announced that 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. 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 micrograms, or placebo. serenity ii will evaluate patients with agitation associated with bipolar disorder, also with each of three arms receiving either bxcl501 at 120 micrograms, 180 micrograms, or placebo. the primary endpoint of both trials will be the reduction of symptoms of acute agitation in patients with schizophrenia and bipolar disorder using the positive and negative syndrome scale, measuring the excited component (pec) change from baseline compared to placebo. the 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.
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