Phamaceutical company InterveXion has enrolled the first patient in STAMPOUT, the first trial in methamphetamine users of the anti-methamphetamine antibody IXT-m200. STAMPOUT will be a phase 2a, parallel-group, placebo-controlled, double-blind study of the effect of IXT-m200 on methamphetamine pharmacokinetics and subjective effects in methamphetamine users.
Catalent Pharma Solutions supported the InterveXion effort by engineering the cell line that expresses the drug’s antibody employing proprietary GPEx technology and completing process development. Catalent provided cGMP manufacturing for the clinical trial at the company’s Madison, WI, 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 is intended to 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.
Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines. GPEx technology applications 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.
With the $950 million acquisition of Cook Pharmica LLC, in October 2017, Catalent strengthened its position in integrated biologics development, clinical and commercial-scale manufacturing, and finished product supply.
(Source: Catalent Pharma Solutions)