Data Integrity Questions Cast Pall On Alzheimer’s Agitation Data For BioXcel’s Igalmi

The company reported positive efficacy results, but also revealed allegations that an investigator had failed to adhere to trial protocol and was alleged to have fabricated emails to cover their tracks.

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Execs at BioXcel Therapeutics, Inc. were bullish on data from the Phase III TRANQUILITY II study of Igalmi (dexmedetomidine) in Alzheimer’s disease-related agitation, but problems at a trial site that enrolled a large percentage of the study’s participants cast a shadow over the announcement, and the company may have a difficult time getting out from under it.

BioXcel announced 29 June results from the trial of Igalmi, also known as BXCL501, showing that the study met its primary endpoint of showing a reduction in PEC score from baseline at two hours at the 60mcg dose, but missed statistical significance at the 40mcg dose, where data indicated a high placebo response rate

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