BioXcel Therapeutics Reports Positive Human Proof-of-Concept Data for Acute Treatment of Agitation in Patients with Alzheimer’s Disease
January 03, 2019 at 06:30 pm IST
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BioXcel Therapeutics, Inc. announced proof-of-concept data from its Phase 1 study of IV (intravenous) dexmedetomidine (Dex) for acute treatment of agitation in patients with Senile Dementia of the Alzheimer's Type (SDAT). 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 progresses. 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. This study enrolled a total of 14 SDAT patients. Ten patients in the treatment arm received IV Dex therapy, while 4 patients received placebo. In accordance with study designs used in previous participant populations, Dex treatment was begun at 0.1 mcg/kg/h and dose escalation occurred every 30 minutes by increasing the infusion rate by 0.1 mcg/kg/h to a maximum infusion of 0.5 mcg/kg/h. Such dosing allowed for the efficient determination of the optimal dose in each participant. The study demonstrated that 7 out of 10 patients in the treatment arm achieved arousable sedation (RASS score of -1), with only 1 of 4 patients in the placebo arm. The drug was well tolerated without any clinically significant adverse events.
BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop medicines in neuroscience. Its subsidiary, OnkosXcel Therapeutics, develops medicines in immuno-oncology. The Companyâs most advanced neuroscience candidate, BXCL501, is an investigational, proprietary, orally dissolving film formulation of Dex in development for the treatment of agitation associated with psychiatric and neurological disorders. It is continuing to develop BXCL501 for the potential acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting and for the potential acute treatment of agitation (non-daily) associated with dementia due to probable Alzheimers disease in the at-home setting and in care facilities. Its most advanced immuno-oncology candidate, BXCL701, is an investigational oral innate immune activator for the treatment of aggressive forms of prostate cancer, pancreatic cancer, and other solid and liquid tumors.