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BTAI

BioXcel Therapeutics

$10.48

0.25 (2.44%)

06:02
07/22/19
07/22
06:02
07/22/19
06:02

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.

BTAI BioXcel Therapeutics
$10.48

0.25 (2.44%)

12/05/18
HCWC
12/05/18
NO CHANGE
Target $25
HCWC
Buy
BioXcel Therapeutics data establish proof-of-concept, says H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju reiterates a Buy rating on BioXcel Therapeutics with a $25 price target after the company reported that its Phase 1b dose-ranging study of IV form of BXCL501 met the primary endpoint, with 90% of the 10 schizophrenic patients enrolled reaching a Richmond Agitation-Sedation Scale score of -1 without any significant adverse effects being observed. These data provide confirmation that BXCL501 effectively produces arousable sedation in both schizophrenic and bipolar patients, Selvaraju tells investors in a research note. The analyst anticipates that the Phase 1b data in Alzheimer's disease patients, slated for release in the coming weeks, is likely to similarly provide proof-of-concept referential evidence of sedation, albeit perhaps with a different pharmacokinetic profile.

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