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December 17, 2021

BioXcel begins Phase 3 study of agitation drug for Alzheimer’s disease

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

A potential treatment for agitation in patients suffering from Alzheimer’s disease is moving closer to market.

New Haven-based BioXcel Therapeutics, Inc. this week announced the start of its Phase 3 program for its drug candidate BXCL501. 

The program’s two studies, dubbed Tranquility II and Tranquility III, will evaluate the investigational drug’s safety and effectiveness in adults 65 years and older with Alzheimer’s who are living in assisted living facilities and nursing homes.

BXCL501, or dexmedetomidine, is designed to dissolve in the mouth, similar to a mouthwash strip, and calm agitation.

Currently, there are no FDA approved treatments for agitation for Alzheimer’s patients.

The two Phase 3 studies will enroll a total of 300 patients, or 150 patients in each study. The patients will ingest 40 mcg or 60 mcg of BXCL501, or a placebo, whenever agitation episodes occur for three months.

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

The patients who complete the studies will be eligible to enroll in a 52-week study designed to measure the drug’s safety and efficacy in longer-term use.

Vimal Mehta, CEO of BioXcel, noted how the company last March obtained breakthrough therapy designation from the FDA, based on results of its Phase 1b/2 study. This designation can help speed up the regulatory review process.

“Following multiple meetings with the FDA, we are pleased to announce the initiation of our Phase 3 program,” Mehta said, in an announcement. “This marks an important advancement in potentially bringing this novel treatment to the more than 4 million patients who experience agitation as one of AD’s most devastating symptoms.”

BioXcel uses artificial intelligence to develop medicines in neuroscience and immuno-oncology.

Contact Michelle Tuccitto Sullo at msullo@newhavenbiz.com.

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