Equillium announces data from Type B portion of EQUALISE study

Equillium announced that data from the Type B portion of the EQUALISE study evaluating itolizumab in lupus nephritis patients was presented at ACR Convergence, the annual meeting of the American College of Rheumatology, or ACR. The data highlights that subjects had high complete and partial response rates with rapid and deep reduction in urine protein creatinine ratio, or UPCR, when itolizumab was added to mycophenolate mofetil, or MMF, and corticosteroids. The Type B portion of the EQUALISE study in patients with active proliferative LN, or apLN, is evaluating the safety, tolerability and clinical activity of subcutaneous delivery of itolizumab. Patients must present with greater than one gram of proteinuria and have a recent kidney biopsy showing ISN/RPS class III or IV apLN to be eligible for the study. During the 24-week treatment period, patients receive a subcutaneous dose of 1.6 mg/kg every two weeks, with follow up out to 36 weeks. Consistent with standard of care, patients on study also receive 2-3 g/day of mycophenolate mofetil/mycophenolic acid, or MMF/MPA, and patients may receive pulse systemic corticosteroids that are rapidly tapered. A total of 17 subjects have been enrolled in the study, with 15 subjects reaching Week 28. Based on published guidelines for the management of lupus nephritis from the European League Against Rheumatism, or EULAR, and European Renal Association-European Dialysis and Transplant Association, clinical activity assessments in this study are focused on the change in UPCR from baseline; proportion of apLN subjects with a complete response, or 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, or PR, defined as 50% or greater reduction in UPCR.