BioXcel looks to expand label to at-home use for lead psych drug. Initial data are mixed

BioXcel reported Thursday morning that Igalmi, a drug approved to treat agitation in patients with certain psychiatric disorders, had mixed results in the first part of a Phase III study.

The biotech hopes to use the study to expand Igalmi’s label so the drug can be used at home — and would not have to be administered with a healthcare provider present.

At two hours post-treatment, people who received the drug did not perform significantly differently on a scale that measures agitation from those who received placebo — but the p-value just barely missed the cut at 0.077. But at four hours post-treatment, there was more separation between the two groups, and with a p-value of 0.049, the difference was statistically significant.

Around half of all patients were considered responders to treatment at hour two, BioXcel said.

The first part of the study was conducted at institutions, and the second part will be conducted in home settings. BioXcel hopes that the full study can be used to support an expanded label for Igalmi as a treatment for agitation in bipolar disorders and schizophrenia at home. Currently, there are no treatments approved for at-home use.

Investors were unimpressed by the data, with BioXcel’s stock $BTAI falling around 18% on Thursday morning to around $21.00 per share.

Igalmi is currently approved for treatment of agitation in bipolar disorders and schizophrenia at 120 and 180 mcg doses. It comes as a film, similar to a Listerine strip, that goes under the tongue. For at-home use, BioXcel is testing the treatment at much smaller doses — this study looked at a 60 mcg dose, and BioXcel said part 2 would look at 60 mcg and possibly 80 mcg.

Robert Risinger

“We chose half of the lowest approved Igalmi dose, 60mcg, with the goal of increasing the margin of safety while supporting efficacy for at-home use,” Robert Risinger, BioXcel’s CMO of neuroscience, said in a news release. He noted the drug “was originally sequestered in the surgical unit as an anesthetic, then approved by the FDA as Igalmi to treat agitation in adult patients with schizophrenia or bipolar disorders in medical settings, before being investigated now for at-home use.”

BioXcel told Endpoints News that it plans to start the second part of the study this quarter but declined to comment on further trial timelines.

With the lower dose, BioXcel said there were no reported serious adverse events. The most common side effects were drowsiness, tingling in the mouth and dry mouth. There were two reports of low blood pressure in the treatment groups.

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