BioXcel Therapeutics announces results from adaptive Phase 1b trial of BXCL501
BioXcel Therapeutics announced positive top-line results from the adaptive Phase 1b, randomized, double-blind, placebo-controlled, multi-center, U.S. trial, evaluating multiple doses of BXCL501 for acute treatment of agitation in 135 patients with schizophrenia. In the trial, a reduction in the PEC score for agitation was observed with rapid calming without excessive sedation at two hours and at earlier time-points. The 80 mcg, 120 mcg and 180 mcg doses of BXCL501 showed reductions of PEC scores of -7.1, -9.2 and -10.8, respectively, compared to -4.5 for placebo at two hours. The results for these three doses were statistically significant in patients treated compared to placebo. BTI also observed clinically meaningful but not statistically significant reductions in PEC scores of -6.0 following 60 mcg at two hours. The Company believes that these results suggest a predictable and dose-dependent response for BXCL501. The secondary evaluations included assessment using ACES which evaluated the potential calming effects of BXCL501.