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Equillium Announces Update to EQUALISE Study of Itolizumab in Patients with Systemic Lupus Erythematosus and Lupus Nephritis
Analysis of our Type A systemic lupus erythematosus patients without lupus nephritis that had elevated baseline urine protein/creatinine and
About this update from Equillium, Inc.
[{"type":"text","content":"\nAnalysis of our Type A systemic lupus erythematosus patients without lupus nephritis that had elevated baseline urine protein/creatinine and albumin/creatinine ratios demonstrated a mean decrease of 42% and 53% respectively by Day 57 following two doses of Itolizumab\n\nThe Type B lupus nephritis cohort has been expanded to include newly diagnosed patients, in addition to refractory patients, and will evaluate a single subcutaneous dose level based on Type A PK/PD results\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 additional data from the EQUALISE Type A portion of the study in systemic lupus erythematosus (SLE) patients. The exploratory data set shows that patients without a diagnosis of lupus nephritis (LN) but with elevated urine protein/creatine ratio (UPCR) >200 mg/g (N=6, baseline geometric mean 378 mg/g)1 experienced a mean decrease from baseline in UPCR of 33% and 42% at Days 29 and 57 respectively, following subcutaneous doses of itolizumab on Days 1 and 15. Notably, one subject who had baseline UPCR of 1,505 mg/g declined to 974 mg/g at Day 29 and 857 mg/g by Day 57. Additionally, patients with elevated albumin/creatinine ratio (ACR) >30 mg/g (N=4, baseline geometric mean 97 mg/g)1 experienced a mean decrease from baseline in ACR of 22% and 53% at Days 29 and 57 respectively.\n\n“We are intrigued by this observation from our Type A portion of the study in SLE patients who did not have a diagnosis of lupus nephritis and entered the study with elevated proteinuria, and experienced reductions in UPCR and ACR following two doses of itolizumab,” said Dolca Thomas, executive vice president of research and development and chief medical officer of Equillium. “There is ongoing research in the field of rheumatology and nephrology that suggests patients who have elevated proteinuria with UPCR greater than 200 mg/g or ACR greater that 30 mg/g, which is below the typical diagnostic threshold for LN and other kidney diseases, may have subclinical disease - sometimes referred to as silent LN - where early intervention with a safe and active therapy may prevent more severe outcomes. We are continuing to analyze this exploratory data and look forwa...