BioXcel Therapeutics Achieved Targeted Exposures of BXCL501 Designed For Non-Invasive Acute Treatment of Agitation in Neuropsychiatric Diseases

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May 20, 2019 07:30 ET | Source: BioXcel Therapeutics, Inc.

Phase 2 efficacy trial in agitated schizophrenia patients anticipated to commence imminently

BXCL501 is a potential first-in-class selective alpha-2a receptor agonist, formulated as a proprietary sublingual thin film of dexmedetomidine

Targeted exposure levels that were observed to be therapeutic in prior IV Dex study rapidly achieved in preliminary pharmacokinetic profile from Phase 1 study

On track to initiate first Phase 3 pivotal trial in 2H 2019 with NDA submission expected in 2020

Global development plans in agitated dementia, opioid withdrawal symptoms and hyperactive delirium to expand market will be unveiled through 2019

Conference call to discuss results and BXCL501 program advancement on May 20, 2019 at 8.30 ET

NEW HAVEN, Conn., May 20, 2019 (GLOBE NEWSWIRE) – BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI), today announced positive top line data from its Phase 1 pharmacokinetic (PK) (bioavailability) and safety study of BXCL501, a proprietary sublingual thin-film formulation of dexmedetomidine (Dex), for the acute treatment of agitation across multiple neuropsychiatric indications. Administration of BXCL501 in the Phase 1 pharmacokinetic and safety study successfully 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.

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