Equillium Gets Fast Track for Itolizumab

FDA has granted Equillium a fast track designation for itolizumab for treating lupus nephritis. In September, Equillium initiated the EQUALISE Phase 1b study of itolizumab in patients with lupus and lupus nephritis. The study will have two cohorts: Type A is an open-label cohort and will treat patients with systemic lupus erythematosus for four weeks; Type B is a double-blind, placebo-controlled cohort and will treat patients with active proliferative lupus nephritis for 12 weeks, according to the company.

Itolizumab is described as a clinical-stage, first-in-class monoclonal antibody that selectively targets the novel immune checkpoint receptor CD6. “CD6 plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases,” it says. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.