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Equillium Announces Interim Safety Data and Reduction in Proteinuria for Lupus Patients Treated with Itolizumab in the EQUALISE Study Presented at the ACR Annual Meeting
Subgroup analyses of lupus patients (without lupus nephritis) that had elevated baseline proteinuria and albuminuria shows reduction of 42% and 54%,
About this update from Equillium, Inc.
[{"type":"text","content":"\nSubgroup analyses of lupus patients (without lupus nephritis) that had elevated baseline proteinuria and albuminuria shows reduction of 42% and 54%, respectively, by Day 57\n\nItolizumab was well tolerated at doses ranging from 0.4 to 2.4 mg/kg\n\n LA JOLLA, Calif.--(BUSINESS WIRE)--\nEquillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that positive interim data from the Type A portion of the EQUALISE study in systemic lupus erythematosus (SLE) patients were presented in a poster session at the American College of Rheumatology (ACR) annual meeting. The data in poster #1750, authored by Kenneth Kalunian, M.D., professor of Medicine, at University of California San Diego School of Medicine, showed that itolizumab administration was well tolerated and resulted in decreases in proteinuria and albuminuria, two key biomarkers of disease risk.\n\nIn the interim exploratory analysis of the TYPE A portion of the study where patients were dosed subcutaneously (SC) once every two weeks (Q2W), the data showed that for SLE patients with baseline urine protein-to-creatinine ratios (UPCR) > 100 mg/g (N=16) and > 200 mg/g (N=6), there was a decline of 34% and 42%, respectively, at Day 57. In addition, for patients with a baseline urine albumin-to-creatinine ratio (UACR) > 30 mg/g (N=4) there was a decline of 54% at Day 57. Pharmacokinetic analysis showed dose dependent increases in itolizumab concentrations while pharmacodynamic data showed a reduction in the CD4 cell surface CD6 levels, with maximal reductions achieved at itolizumab doses ≥ 1.6 mg/kg. Treatment with two doses of itolizumab up to 2.4 mg/kg was found to be well tolerated, with mild injection site reaction and headache reported as the most common adverse events.\n\n“These early results in patients with SLE treated with itolizumab are quite promising,” said Dr. Kalunian. “In particular, the substantial decreases in protein-creatine and albumin-creatine ratios, two key biomarkers of inflammation and disease severity in this patient population, following just two doses of itolizumab are impressive. I look forward to additional data from EQUALISE, including observations from the Type B portion of the study in patients with lupus nephritis.”\n\nT...