Yale researchers are launching a study to see if an anti-agitation drug developed by a New Haven biotech can help people with alcohol and substance abuse disorders related to post-traumatic stress.
BioXcel Therapeutics announced this week it will collaborate with the VA Connecticut Healthcare System and the Yale University School of Medicine on the investigator-led study.
The study will be supported by a U.S. Department of Defense Congressionally Directed Medical Research Programs grant awarded to the VA Connecticut Research & Education Foundation, according to a spokeswoman for the grant program. The amount of the grant is $807,911, she said.
The experimental drug, BXCL 501, is a minty, thin film formulation of an older drug known as dexmedetomidine or “DEX.” It dissolves under the tongue or inside the cheek.
The company is on track to apply for FDA approval of the drug in early 2021 to treat agitation in patients with schizophrenia and bipolar disorder. Successful results of a Phase 3 clinical trial were announced last summer.
But Chief Scientific Officer Frank Yocca said this will be the first time the drug will be studied as a treatment for a chronic condition.
“We believe this product candidate. . .has the potential to reduce and alleviate the frequent hyperarousal symptoms that individuals with PTSD can experience on a daily basis,” Yocca said.
After an initial safety assessment, a follow-on study is expected to evaluate patients who self-administer the drug daily at home for 28 days, BioXcel said.
Principal investigators will be Dr. Ismene Petrakis, chief of psychiatry services at VA Connecticut Healthcare System and professor of psychiatry at Yale School of Medicine; Dr. John Krystal, director of the clinical neuroscience division of the Department of Veterans Affairs’ National Center for PTSD; ad Robert L. McNeill Jr., chair of the psychiatry department at Yale.
Based at 555 Long Wharf Dr., BioXcel uses artificial intelligence to repurpose older drugs and discover new ones.
This story has been updated to include the amount of the grant.
Contact Natalie Missakian at news@newhavenbiz.com
