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

 
• By Alaric DeArment

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.

• Source: Shutterstock

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...

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