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BioXcel Therapeutics announces positive results from its TRANQUILITY study for the treatment of agitation in dementia

Tuesday 05 January 2021

On 5 January, BioXcel Therapeutics, a clinical-stage biopharmaceutical focused on drug development that utilises artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, announced positive topline results for its Phase Ib/II trial evaluating BXCL501 for the treatment of agitation in dementia.

The TRANQUILITY Phase Ib/II trial was a randomised, double-blind, placebo-controlled and ascending dose study evaluating the efficacy, pharmacokinetics, safety and tolerability of BXCL501 in people of 60 years and older who have acute agitation associated with all forms of dementia. A total of 54 participants were enrolled in the trial; they received BXCL501 at either 30 µg (n=16), 60 µg (n=20), 90 µg (n=4) or placebo (n=14). 87% of these participants had Alzheimer's disease (AD).

Top-line results showed that BXCL501 was generally well tolerated, with no severe or serious adverse events reported, with the most common side effect being somnolence. The trial met its secondary efficacy endpoints in the higher evaluable dose (60 µg) compared to placebo as BXCL501 was found to statistically reduce the agitation in people with different forms of dementia, including AD, as measured by several agitation scales. These reductions were both rapid and durable.