BioXcel Shares Drop Premarket Following Results for Phase 3 Trial of BXCL501
6:58 am ET June 29, 2023 (Dow Jones) Print
By Robb M. Stewart
BioXcel Therapeutics' shares were down sharply ahead of the bell after a late-stage trial of the biopharmaceutical company's investigation treatment for Alzheimer's disease-related agitation met its main target but missed one of the key secondary goals.
In premarket trading, the shares were 36% lower after ending Wednesday at $17.67, down 18% so far this year.
BioXcel said the topline results from its Phase 3 trial of BXCL501, an orally dissolving film formulation of dexmedetomidine, were positive and the study met its primary efficacy endpoint. The 60 mcg dose also met the first key secondary endpoint of reducing agitation symptoms at one hour during the first episode of agitation, but didn't meet the other key secondary endpoint of change from baseline in PEC score at 30 minutes, the company said.
Efficacy for the dose was supported by a number of secondary measures, and most patients responded to the first 60 mcg dose and were determined to be "very much" or "much improved" compared to 50% with placebo, BioXcel. It added the primary endpoint wasn't met for the 40 mcg dose.
Chief Executive Vimal Mehta said the results represent a milestone, and data from the Tranquility II trial show that BXCL501 has the potential to treat acute episodes of agitation in patients with mild to moderate Alzheimer's disease, if approved.
BioXcel said it plans to develop a path to potential supplemental new drug application submission for the acute treatment of agitation associated with Alzheimer's disease in the second half of the year, subject to further discussions with the Food and Drug Administration.
BXCL501 has been granted a breakthrough therapy designation for the acute treatment of dementia-related agitation based on Tranquility I data.
