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 supported InterveXion by engineering the cell line, which expresses the drug’s antibody employing its proprietary GPEx technology and completing process development. Catalent provided cGMP manufacturing for the clinical trial at the company’s Madison (Wisconsin, USA) 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 behavioral 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.
He added, “We continue to work closely with innovative organizations such as InterveXion to bring potentially life-changing products to patients.”
Misty Stevens, PhD, Operations Director, InterveXion, commented: “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.”
Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial scale production.
To date, seven GPEx-based antibody and protein products are approved and marketed, and more than 40 therapeutic candidates are currently in the clinic across the world.
