logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
European Union has ordered Broadcom (AVG) to stop applying certain exclusivity agreements with six of its main customers. According to European Union, this will prevent serious and irreparable harm to competition likely to be caused by Broadcom's conduct. In June, the European Commission opened... Amazon.com Inc. (AMZN) announced that it will live stream behind the scenes of its Robotics Fulfillment Center to for students pursuing STEM and Computer Science education. Amazon said on Thursday, October 17 at 7:00 p.m. ET / 4:00 p.m. PT, teachers and students can go online to Twitch to watch and... Walmart has rolled back prices on more than 200 additional toys in stores and online as it braces for the upcoming holiday season. The retail giant is now offering more than 400 toys at a special price, thanks to its already existing rollbacks on toys. In August, Walmart unveiled its list of top-rated toys for 2019 that were selected by kids.
Follow RTT
>