A drug discovered at the University of Arkansas for Medical Sciences (UAMS) to counter the effects of methamphetamine will be tested in a phase 2 clinical trial as the only potential treatment of its kind for methamphetamine use disorder.
The study is led by UAMS startup biopharmaceutical company InterveXion Therapeutics, LLC, and is funded by a three-year, $13.8 million grant from the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA).
The drug, IXT-m200, could be the first monoclonal antibody treatment for methamphetamine use disorder and overdose. It received the U.S. Food and Drug Administration (FDA) Fast Track Designation in 2016 for treatment of methamphetamine use disorder. FDA Fast Track Designation facilitates the development and speeds the review of drugs to treat serious conditions and fill an unmet medical need.
“There is an urgent need for an effective treatment, and we’re excited to begin this next phase of testing,” said Brooks Gentry, MD, one of the grant’s principal investigators and a professor in the UAMS College of Medicine Departments of Anesthesiology and Pharmacology and Toxicology. “Because there are no medications out there to treat meth use disorder or overdose, we hope the FDA Fast Track Designation will help us move a little more quickly.”
Gentry, the chief medical officer for InterveXion, noted that the number of people in the United States with methamphetamine use disorder increased by 62% between 2015 and 2019, and overdose deaths increased by 43%.
UAMS, which has partial ownership of InterveXion, will receive a sub-award of $388,876 to support the clinical trial, named the OUTLAST trial.