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May 11, 2022

BioXcel doses first patient in Alzheimer’s agitation drug trial 

PHOTO | STEVE LASCHEVER BioXcel Therapeutics CEO Vimal Mehta
By Michelle Tuccitto Sullo

BioXcel Therapeutics Inc. announced this month that it has dosed its first patient in a Phase 3 study of its drug candidate for agitation in patients with Alzheimer’s disease.

The study is evaluating the safety and effectiveness of BXCL501, an orally-dissolving thin film formulation of dexmedetomidine.

The New Haven-based biopharmaceutical company’s “Tranquility” program study is focused on adults aged 65 years and older who live in assisted living facilities and nursing homes.

Dr. Robert Risinger, chief medical officer with BioXcel, said there are roughly 100 million episodes of agitation in Alzheimer’s patients in the United States annually.

These episodes can have a “devastating impact” both on patients and those who are taking care of them, Risinger said.

The U.S. Food and Drug Administration has already approved the use of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorder in adults.  

According to Risinger, the company believes this approval has laid a “strong foundation” for its use in Alzheimer’s disease patients also.

The company plans to have more than 10 clinical trial sites around the United States. 

“We are making strong and swift efforts to potentially bring BXCL501 and its proven ability to address agitation to this large market,” Risinger said.

The Phase 3 study is divided into two parts, Tranquility II and Tranquility III. The company anticipates top-line data for Tranquility II in late 2022 or early 2023. The Tranquility III study is underway, with patient enrollment beginning later this year.

Tranquility II involves Alzheimer’s patients who need minimal assistance with daily living. Tranquility III will involve patients with moderate to severe dementia who require more assistance.

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.
 

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