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January 5, 2021 Bioscience

BioXcel agitation drug calms dementia patients in trial

IMAGE | Pixabay.com
By Natalie Missakian

New Haven’s BioXcel Therapeutics unveiled clinical trial results Tuesday showing its experimental anti-agitation drug could successfully and quickly calm patients suffering from dementia.

BioXcel said BXCL501, its mint-flavored, quick-dissolving thin-film version of an older Pfizer drug, met all of its primary and secondary objectives in the Phase 1b/2 study. No serious adverse effects were reported.

“Based on the results observed, we believe BXCL501 has a broad potential for treatment of the full spectrum of agitation in patients with dementia,” CEO Vimal Mehta said in a statement. 

He said the positive results pave the way for a late-stage study later this year, following dialogue with the Food and Drug Administration.

Mehta said despite decades of research, there are still no effective treatments that directly target agitation commonly seen in dementia, which affects around 4 million people in the U.S. 

The study was designed to identify a recommended dose of the drug to test in an upcoming Phase 3 trial. It enrolled 54 patients in assisted living facilities with agitation related to dementia, most of whom had Alzheimer’s disease. 

It found that a 60 mcg dose of the drug outperformed a placebo with a statistically significant, rapid and long-lasting reduction in agitation based on multiple agitation scales.

The results showed 70% of patients given that dose experienced a more than 40 percent reduction in agitation after 60 minutes, based on a widely-used “excitability” scale. 

The study also found statistically significant improvements using two other measures of agitation. The effects lasted for eight hours after the medicine was administered.

BioXcel’s stock, which trades on the Nasdaq under the symbol BTAI, saw a slight bump in premarket trading on the news, but was back to trading at around $50 a share as of noon.

Dementia is one of five possible uses BioXcel is testing or planning to test for the drug, which it discovered and repurposed using artificial intelligence.

The drug is closer to regulatory approval for patients with schizophrenia and bipolar disorder. BioXcel expects to submit a New Drug Application with the FDA for those indications early this year. 

Contact Natalie Missakian at news@newhavenbiz.com

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