InterveXion Enrolls First Patient in OUTLAST, a Phase 2 Study of IXT-m200 in METH Use Disorder
- First clinical trial of an anti-METH antibody in patients seeking treatment for methamphetamine use disorder
LITTLE ROCK, ARKANSAS, USA, July 5, 2022 /EINPresswire.com/ -- InterveXion Therapeutics, a clinical-stage biopharmaceutical company, today announced the enrollment of the first patient in OUTLAST, a Phase 2 study of the first-in-class anti-methamphetamine antibody IXT-m200 in patients seeking treatment for methamphetamine use disorder.
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.
OUTLAST (NCT05034874) will evaluate the efficacy and safety of IXT-m200 administered in conjunction with cognitive behavioral therapy in patients seeking treatment for methamphetamine use disorder. OUTLAST is funded under a three-year, $13.8 million grant award (U01DA055481) 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.
“Thanks to the hard work of our team and our clinical investigators, we are very pleased to announce that the OUTLAST trial is now underway,” said W. Brooks Gentry, M.D., InterveXion’s Chief Medical Officer. “There are no FDA-approved medications specifically for people with methamphetamine use disorder, and we are excited to conduct OUTLAST and determine whether IXT-m200 may help patients overcome their methamphetamine addiction”.
OUTLAST is a randomized, placebo-controlled study of IXT-m200 in people seeking treatment for methamphetamine use disorder. Participants (n=120) will be enrolled in two sequential cohorts, each of which will randomize participants 2:1 to IXT-m200 or placebo, with a low dose of IXT-m200 to be studied in Cohort 1 and a higher dose in Cohort 2. Each participant will also receive standard cognitive behavioral therapy, and will undergo regular self-reporting and saliva testing for drug use. Participants will receive 6 doses of IXT-m200 or placebo, given once monthly, and safety and efficacy will be evaluated over a period of approximately 33 weeks.
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. For more information, visit https://www.intervexion.com.