InterveXion Enrolls First Patient in Meth-OD, a Phase 2 Study of IXT-m200 in METH Overdose
Updated: Sep 20
LITTLE ROCK, AR, USA, September 20, 2021 – InterveXion Therapeutics, a clinical-stage biopharmaceutical company, today announced the enrollment of the first patient in Meth-OD, a Phase 2 study of the first-in-class anti-methamphetamine antibody IXT-m200 in patients with methamphetamine overdose.
IXT-m200, a monoclonal antibody that specifically binds methamphetamine in the blood, is being developed both for acute methamphetamine overdose and as a chronic therapy for patients seeking to overcome methamphetamine use disorder. InterveXion has previously released positive data from the Phase 2 STAMPOUT study of IXT-m200 in people who use methamphetamine.
Meth-OD (NCT04715230) will evaluate the ability of IXT-m200 to reduce agitation in patients presenting to an emergency department with acute methamphetamine toxicity. Meth-OD is funded under a three-year $8.1 million grant award (U01DA053043-02) from the National Institutes of Health/National Institute on Drug Abuse (NIH/NIDA) which has funded previous and ongoing development of IXT-m200. A sub-award to the University of Arkansas for Medical Sciences (UAMS) is part of the grant, and UAMS will continue to play an important role in the advancement of IXT-m200 development. InterveXion is a BioVentures, LLC company housed on the UAMS campus in Little Rock, AR.
“We are very pleased that the Meth-OD trial is now underway,” said W. Brooks Gentry, M.D., InterveXion’s Chief Medical Officer. “Over 300,000 people a year present to emergency departments in the United States with methamphetamine overdose, and methamphetamine overdose now is responsible for more deaths than opioid overdose in the western half of the country. There is an urgent need for pharmacologic therapies for these patients, and we are eager to conduct the Meth-OD study and determine whether IXT-m200 may offer support for patients suffering from acute methamphetamine toxicity”.
In Meth-OD, InterveXion plans to enroll approximately 40 patients with methamphetamine overdose at five emergency departments in the United States, using a randomized open-label design comparing IXT-m200 with treatment-as-usual. Study participants will provide assent, and consent for study participation will also be obtained from a legally authorized representative. Meth-OD will evaluate the safety and tolerability of IXT-m200 in this population, as well as the ability of IXT-m200 to reduce signs and symptoms of methamphetamine toxicity.
InterveXion is the leading biopharmaceutical company developing immunotherapies for patients with methamphetamine use disorder. InterveXion’s lead product, IXT-m200, is a monoclonal antibody against methamphetamine with positive Phase 2 data and which has received US FDA Fast Track Designation for treatment of methamphetamine use disorder.