Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients. The data suggests high complete and partial response rates with rapid and deep reduction in urine protein creatinine ratio (UPCR) when itolizumab was added to mycophenolate mofetil/mycophenolic acid (MMF/MPA) and corticosteroids. The topline data delivered to our partner, Ono Pharmaceutical, represents the first of two data set triggers leading to their decision as to whether to exercise their option to acquire itolizumab, which is expected in the second half of 2024.

“Physicians want to rapidly and safely reduce the levels of proteinuria in patients with lupus nephritis, as this has been associated with improved long-term outcomes, so it is important that we saw both early and large reductions in proteinuria in this study,” said Dr. Maple Fung, chief medical officer at Equillium. “The high complete and partial response rates compare favorably to those observed in the registrational studies of voclosporin, which demonstrated an overall response rate of seventy percent at six and twelve months in the active treatment groups. These itolizumab results occurred in the setting of patients tapering their systemic corticosteroids, maintaining stable kidney function, or eGFR, and increasing serum albumin while on study.”

A total of 17 subjects were enrolled in the study, with 16 subjects analyzed as completing through Week 36 (12 weeks following the final dose, or their end of study (EOS) visit). Based on published guidelines for the management of lupus nephritis from the European League Against Rheumatism (EULAR) and European Renal Association-European Dialysis and Transplant Association (ERA-EDTA), clinical activity assessments in this study are focused on the change in UPCR from baseline; proportion of apLN subjects with a complete response (CR), defined as 50% or greater reduction in UPCR and less than 0.5-0.7 g/g; and proportion of subjects achieving a partial response (PR), defined as 50% or greater reduction in UPCR.