Devextinetug safe and well-tolerated in patients presenting with methamphetamine overdose, and normalized agitation without producing sedation
LITTLE ROCK, AR, USA, July 20, 2023 – InterveXion Therapeutics, a private clinical-stage biopharmaceutical company developing immunotherapies for substance abuse disorders, today announced positive final results from its Phase 2 study of devextinetug (IXT-m200, an anti-methamphetamine antibody) in patients presenting to an emergency department with mild to moderate methamphetamine overdose.
Meth-OD (NCT04715230) was a randomized, multisite, open-label, Phase 2 study, in which devextinetug was compared to treatment-as-usual (TAU) in patients with acute mild to moderate METH toxicity. Two study cohorts enrolled 10 patients each, using a 4:1 randomization ratio of devextinetug to TAU. Agitation scales and vital signs were recorded over time to track the effect of the antibody treatment versus TAU on agitation associated with METH use. While in the emergency department, detailed safety and pharmacokinetic measurements were also obtained. Following discharge, patients returned for follow-up evaluation 3 and 28 days later.
In Meth-OD, devextinetug was found to be safe and well-tolerated when administered to patients experiencing a methamphetamine overdose. Furthermore, one hour after dosing, a greater proportion of patients receiving devextinetug experienced normalization of agitation scores (8 patients; 50.0%) than the patients receiving TAU (1 patient; 25%). Additionally, a smaller proportion of devextinetug-treated patients were sedated (5 patients; 31.3%) than those receiving TAU (3 patients; 75.0%).
“Completion of Meth-OD represents an important step in the development of therapies for patients experiencing methamphetamine overdose,” said InterveXion’s Chief Medical Officer W. Brooks Gentry, M.D. “Establishing safety of devextinetug in this emergency department setting allows us to plan further studies in an even broader overdose population. We are encouraged by the normalization of agitation by devextinetug observed in Meth-OD, and we are grateful to our patients and study investigators for helping complete this key study.”
In addition to methamphetamine overdose, InterveXion is continuing development of devextinetug for treatment of patients with methamphetamine use disorder. OUTLAST (NCT05034874) is evaluating the safety and efficacy of devextinetug administered in conjunction with cognitive behavioral therapy in patients seeking treatment for methamphetamine use disorder, for which InterveXion has been granted FDA Fast Track Designation.
InterveXion is the leading biopharmaceutical company developing immunotherapies for patients with methamphetamine use disorder. InterveXion’s lead product, devextinetug (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.