Equillium announced that the U.S. Food and Drug Administration has granted Fast Track designation for itolizumab for the treatment of lupus nephritis.
The FDA’s Fast Track program is designed to facilitate the development of new treatments for serious or life-threatening conditions for which there is a significant unmet medical need. Companies with investigational drugs that receive Fast Track designation benefit from more frequent meetings or communications with the FDA to discuss the drug’s development plan and may be eligible for accelerated approval and priority review.
Equillium initiated a phase 1b trial, EQUALISE, in September of 2019 to evaluate itolizumab in patients with lupus and lupus nephritis. The randomized, double-blind, placebo-controlled study will have two cohorts: Type A is an open-label cohort and will treat patients with systemic lupus erythematosus for 4 weeks; Type B is a double-blind, placebo-controlled cohort and will treat patients with active proliferative lupus nephritis for 12 weeks.
About itolizumab (EQ001)
Itolizumab (EQ001) is a 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.
Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.
About lupus nephritis
Lupus nephritis is a type of kidney disease caused by systemic lupus erythematosus (SLE or lupus). Lupus is an autoimmune disease—a disorder in which the body’s immune system attacks the body’s own cells and organs. Kidney disease caused by lupus may get worse over time and lead to kidney failure.