Little Rock, AR – InterveXion Therapeutics has received a federal grant to fund a second clinical study of IXT-m200, a monoclonal antibody designed to treat methamphetamine abuse. The clinical trial, called STAMPOUT, will be a Phase 2a, parallel-group, placebo-controlled, double-blind study of the effect of IXT-m200 on methamphetamine pharmacokinetics and subjective effects in methamphetamine users. InterveXion has conducted a robust nonclinical evaluation of the pharmacology, toxicology, and pharmacodynamics of IXT-m200, and has completed an initial Phase 1 clinical safety study with this investigational product.
IXT-m200, a monoclonal antibody that specifically binds METH in the blood, is being developed as a pharmacological treatment for use in conjunction with behavioral therapies. IXT‑m200 is expected to alter METH pharmacokinetics in human subjects resulting in reduced or blocked subjective effects that reinforce METH use. STAMPOUT, a Phase 2a Study of Antibody for Methamphetamine Outpatient Therapy, will provide proof-of-concept that IXT‑m200 can alter METH disposition. This will be the first clinical study in METH users of a biological medication developed specifically for patients with METH use disorders.
“We are thrilled to have the opportunity to test IXT-m200 in methamphetamine users for the first time,” said Misty Stevens, Ph.D., InterveXion’s operations director and co-principal investigator on the grant award. “By showing that an antibody can change the way METH acts and makes a person feel, we will have strong evidence that this type of treatment will work to reduce drug use.”
The three-year $8 million grant award comes from the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) which has funded previous developmental studies of IXT-m200. A sub-award to the University of Arkansas for Medical Sciences (UAMS) is part of the grant and funds researchers who are both founders of the company and also prominent UAMS leaders. InterveXion is a BioVentures, LLC company housed on the UAMS campus in Little Rock, AR.
W. Brooks Gentry, M.D., is co-principal investigator on the new grant. He is a professor and chair of the Department of Anesthesiology in the UAMS College of Medicine and InterveXion’s chief medical officer.
InterveXion is a pharmaceutical company whose mission is to discover and advance innovative medications that reduce the impact of human suffering on individuals and communities. Its vision is to be a leader in the development of antagonist therapies that neutralize toxins in the body and thereby improve patient health. InterveXion’s first medications are a monoclonal antibody and an active vaccine for treating methamphetamine abuse.