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BioXcel Announces Positive Data On Senile Dementia Of Alzheimer's Type; Stock Up

BioXcel Therapeutics Inc. (BTAI) announced proof-of-concept data from its Phase 1 study of IV (intravenous) dexmedetomidine or Dex for acute treatment of agitation in patients with Senile Dementia of the Alzheimer's Type or SDAT.

In Thursday's pre-market trade, BTAI is currently trading at $4.29, up $0.70 or 19.50%.

The positive data from this Phase 1 trial provides evidence to support the continued clinical development of BXCL501 for the acute treatment of agitation under the accelerated Fast Track regulatory process.

Agitation is common across all severities of Alzheimer's Disease, with an increasing prevalence as the disease progresses1. BTI is a clinical stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.

The SDAT trial met its primary endpoint by identifying a safe dose of IV Dex that produced a mild arousable sedation, defined by a RASS2 (Richmond Agitation Sedation Scale) score of -1.

Data from this study, along with data from previously completed Phase 1 studies of IV Dex in agitated patients with schizophrenia and healthy elderly volunteers, is valuable in determining the optimal dose of BXCL501, a sublingual thin film formulation of Dex, being developed for the acute treatment of agitation.

The company noted that it is currently dosing subjects in a Phase 1 placebo-controlled, single dose, dose-escalation study of BXCL501. The study is expected to enroll up to 60 healthy adult volunteers across various dosing groups. The primary endpoints are pharmacokinetics and safety, with secondary endpoints including assessment of pharmacodynamics (PD) and the relationship between BXCL501 concentrations and PD endpoints. The Company expects to report top-line data from this study in the first half of 2019.

BioXcel said it continues to explore a range of target indications for BXCL501 beyond its current focus areas of acute treatment of agitation in schizophrenia, bipolar disorder and dementia.

In addition, the company announced the appointment of Robert Risinger as Vice President Clinical Development.

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