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November 30, 2022

BioXcel launches trial of drug for agitation in bipolar and schizophrenia patients

PHOTO | STEVE LASCHEVER BioXcel Therapeutics CEO Vimal Mehta
By Liese Klein

New Haven-based BioXcel Therapeutics announced Wednesday it had begun treating patients in a trial of its drug designed to treat agitation associated with bipolar disorder and schizophrenia.

The first 13 patients in the trial were dosed with BioXcel’s drug, BXCL501 (dexmedetomidine), which is delivered via a sublingual film and is intended for at-home use. The dosages are the first part of the Phase 3 trial of the drug, which will involve 200 patients in total at 20 sites across the U.S. 

Dr. Robert Risinger, chief medical officer, neuroscience at BioXcel, said, “Evaluating BXCL501 for at-home use is an exciting and important milestone that potentially expands the market opportunity for the treatment of agitation and drives the growth of our neuroscience franchise.”

Risinger said the company anticipates top-line data from the trial in the first half of next year, as well as results from another trial of the drug candidate as a treatment for Alzheimer’s-related agitation. 

“These two near-term pivotal data readouts further reinforce the potential of BXCL501 to address the unmet medical needs of millions of patients,” Risinger said.

A reported 39 million agitation episodes occur in the U.S. each year related to bipolar disorders and schizophrenia, according to BioXcel, with 23 million of these episodes occurring outside of an institutional setting.

BioXcel's IGALMI, a form of BXCL501 intended for the acute treatment of agitation associated with dementia, was granted Breakthrough Therapy and Fast Track designation by the FDA in April.

IGALMI was commercially launched in July and BioXcel reported “positive market reception from key hospital stakeholders” in a report to prospective investors on Oct. 18. 

Contact Liese Klein at lklein@newhavenbiz.com.

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