UAMS startup lands $13.8 million grant for Phase 2 trial to help meth addicts

University of Arkansas for Medical Sciences startup InterveXion Thearapeutics has been awarded a $13.8 million grant from the National Institutes of Health to fund a three-year Phase 2 clinical trial for a drug to help diminish methamphetamine addiction.

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.

IXT-m200 was discovered through research at the University of Arkansas for Medical Sciences to counter the effects of methamphetamine. It is the only potential treatment of its kind for methamphetamine use disorder, according to UAMS.

“There is an urgent need for an effective treatment, and we’re excited to begin this next phase of testing,” said Dr. Brooks Gentry, 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.”

According to Gentry, 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.

A monoclonal antibody is a molecule designed in a lab to aid the immune system attack on other cells or molecules. IXT-m200 has demonstrated the potential to significantly reduce or prevent the euphoric rush that drug users crave by keeping methamphetamine in the bloodstream and out of the brain, where the drug has its most damaging effects.

The funding follows a 2020 grant of $8.1 million to study the same drug as a treatment for methamphetamine overdose.

InterveXion was established through BioVentures LLC by a UAMS research team that included Michael Owens, Ph.D., now professor emeritus, who retired from the Department of Pharmacology and Toxicology in 2019.