The first patient has been enrolled by InterveXion in STAMPOUT — the first trial in methamphetamine users of the first-in-class anti-methamphetamine antibody IXT-m200 — the news of which Catalent Pharma Solutions has welcomed.
addiction
STAMPOUT will be a Phase IIa, parallel-group, placebo-controlled, double-blind study of the effect of IXT-m200 on methamphetamine pharmacokinetics and subjective effects in methamphetamine users.
Catalent has provided support to InterveXion by engineering the cell line that expresses the drug’s antibody using its proprietary GPEx technology and completing process development. Additionally, it provided cGMP manufacturing for the clinical trial at the company’s Madison, Wisconsin biomanufacturing facility.
IXT-m200, a monoclonal antibody that specifically binds methamphetamine in the blood, is being developed as a pharmacological treatment for use in conjunction with behavioural therapies. IXT-m200 is expected to alter methamphetamine pharmacokinetics in human subjects resulting in reduced or blocked subjective effects that reinforce methamphetamine use. STAMPOUT will provide proof-of-concept that IXT-m200 can alter methamphetamine disposition. This will be the first clinical study of a biological medication in methamphetamine users.
“Methamphetamine addiction is a serious global healthcare burden, and we are pleased to be working with InterveXion on this important treatment,” commented Mike Riley, vice president and general manager of Drug Substance and Bioanalytical services for Catalent Biologics. “We continue to work closely with innovative organisations such as InterveXion to bring potentially life-changing products to patients.”
Misty Stevens, PhD, operations director, InterveXion, said: “This is our second antibody production cell line to be developed by Catalent and we’ve been very pleased with the speed of development and high production rates Catalent can achieve early on with minimal optimisation.”