A drug developed by the University of Arkansas for Medical Sciences to counter the effects of methamphetamine is advancing to the next phase of a clinical trial with the help of a $13.8 million grant from the National Institutes of Health. The drug received fast track designation by the Food and Drug Administration in 2016 as this has the potential to be the first pharmaceutical for meth abuse.
The study is being led by UAMS startup biopharmaceutical company InterveXion Therapeutics LLC and is funded through a three-year grant from the NIH and the National Institute on Drug Abuse. A grant from the same entities last year of $8.1 million was to study the drug’s ability to reverse methamphetamine overdoses.
Dr. Brooks Gentry, one of the principal investigators, says the project started over 20 years ago when Arkansas was number one in the country per capita for having methamphetamine labs.
The drug being developed would essentially prevent users from experiencing the euphoria that comes from methamphetamine, Gentry said. The drug, IXT-m200, is an antibody that sits in the bloodstream and binds with meth, preventing it from getting in the brain and starting the release of dopamine. The drug can also remove meth from the sites of action in the brain once it gets there.
“We have an extensive track record in understanding how this antibody could work to help people,” Gentry said.
The most recent phase of the study, he said, showed IXT-m200 significantly changes methamphetamine concentrations in the body. The next phase will be at five sites across the country and focus on methamphetamine overdoses.
With the help of their latest grant, researchers will be able to study the antibody in patients who desire treatment for their methamphetamine disorder.
“We have to get to people and understand how exactly it will work there, but we have a high degree of confidence that this can be a big help to people who want treatment,” said Gentry.
He expects the drug will be available in three to five years. Gentry also noted there are drugs like this in trials for cocaine and opioids.
“We have to continue to work closely with the FDA to figure out exactly what needs to be done,” Gentry said. “We anticipate at least two more trials, one for the overdose and one for treatment, which could take us up to five years to complete.”
According to data from InterveXion, between 2015 and 2019, the number of people in the U.S. with methamphetamine use disorder increased by 62%, while overdose deaths grew by 43%. Meth has become more dangerous in recent years as it is often contaminated with the powerful synthetic opioid fentanyl.
