BioXcel Therapeutics Inc.'s (BTAI:NASDAQ) Phase 3 TRANQUILITY trial will test an Alzheimer's disease agitation drug on two groups of 150 dementia sufferers who are at least 65 years of age, noted H.C. Wainwright & Co. analyst Ram Selvaraju.
One cohort will be made up of people in assisted living or residential facilities who require minimal help with the activities of daily living. A second cohort will will be people living in nursing homes who have moderate to severe dementia and need at least moderate help with those activities.
Over a three-month period, patients will take 40 micrograms (40 mcg) or 60 mcg of BXCL501 or a placebo whenever they feel agitated. Patients will be evaluated two hours after taking those doses.
"The Phase 3 program expands the evaluation of patients in diverse medical settings across the range of dementia severity," Selvaraju wrote. "It is designed to maximize the opportunity of BXCL501 for the treatment of the full spectrum of agitation associated with Alzheimer's disease."
The market size for the drug is significant, Selvaraju noted. About 70% of all people with Alzheimer's disease have agitation, and about 5.8 million people in the United States had Alzheimer's Disease in 2020, according to Alzheimer's Association data. That figure is expected to more than double to 11.8 million by 2040.
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Important Disclaimers for H.C. Wainwright & Co. LLC, BioXcel Therapeutics Inc., Dec. 16, 2021
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