Fast Track Designation Granted for Monoclonal Antibody Targeting Restenosis
XBiotech announced that the company has been granted Fast Track designation by the FDA for its therapeutic monoclonal antibody MABp1 (CV-18C3) as a treatment to reduce the need for re-intervention after superficial femoral artery (SFA) revascularization. MABp1 inhibits chronic sterile inflammation by targeting IL-1a.
A Phase 2 study demonstrated that treatment with MABp1 resulted in prolonged patency of the SFA and reduction in Major Adverse Cardiovascular Events (MACE), indicating both a local treatment effect as well as impact on underlying vascular disease.
This is the second FDA Fast Track Designation secured by XBiotech for MABp1. The first Fast Track Designation was received at the end of last year for the treatment of advanced cancer with associated cachexia.