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BTAI

BioXcel Therapeutics

$10.72 /

-0.21 (-1.92%)

07:50
05/20/19
05/20
07:50
05/20/19
07:50

BioXcel Therapeutics announces data from BXCL501 study

BioXcel Therapeutics announced positive top line data from its Phase 1 pharmacokinetic, or PK, and safety study of BXCL501, a proprietary sublingual thin-film formulation of dexmedetomidine, or Dex, for the acute treatment of agitation across multiple neuropsychiatric indications. Administration of BXCL501 in the Phase 1 pharmacokinetic and safety study achieved targeted exposure levels that were observed to be therapeutic in the company's prior IV Dex study and BTI intends to advance BXCL501 into a Phase 2 trial to evaluate efficacy in agitated schizophrenia patients. We believe the results from the Phase 2 study are expected to facilitate powering of a planned Phase 3 pivotal trial. BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify and advance next wave of medicines in neuroscience and immuno-oncology. The IND-opening Phase 1 study was a double-blinded placebo-controlled, single-dose, dose-escalation study of BXCL501 that enrolled 42 adult volunteers across various dosing groups. The primary endpoints of the study were PK and safety, while secondary endpoints included assessment of pharmacodynamics, or PD, and the relationship between BXCL501 concentrations and PD endpoints. Findings from the study indicate that BXCL501 rapidly achieved targeted exposure levels consistent with the levels observed in the intravenous Dex study in schizophrenia patients that the company announced in November 2018. Results from the Phase 1 study also showed dose-proportional PK consistent with the IV Dex study with PD effects lasting 4 to 6 hours. Additionally, clinical data from the study indicates BXCL501 was well tolerated. There were no serious adverse events. The most common adverse event was drowsiness, observed at rates similar to placebo. All adverse events were mild to moderate and transient. There was no clear sedative effect in comparison with placebo. Cardiovascular changes were not clinically meaningful. A maximum tolerated dose was not reached.

  • 22

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BTAI BioXcel Therapeutics
$10.72 /

-0.21 (-1.92%)

12/05/18 H.C. Wainwright
BioXcel Therapeutics data establish proof-of-concept, says H.C. Wainwright

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