Benzinga | Nov 2, 2021 10:54AM EDT

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

Equillium, 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.

In 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.

"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."

The Type A study portion of the Phase 1b EQUALISE study is a multiple ascending-dose trial involving 35 SLE patients to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of SC doses of itolizumab every two weeks. The Type B portion of the EQUALISE study will evaluate up to 20 newly diagnosed or refractory lupus nephritis (LN) patients who will be treated with itolizumab dosed at 1.6 mg/kg SC Q2W for up to 24 weeks.

In separate posters at ACR, Equillium presented new observations on CD6 as a key pharmacodynamic biomarker of drug activity and the importance of urinary ALCAM as a measure of disease activity in LN. In poster #1766, pharmacodynamic data were presented from the Type A portion of the EQUALISE study in which SC delivery of itolizumab induced dose-dependent loss of cell surface CD6 on T cells (with maximal loss observed at Day 15 between 1.6 and 3.2 mg/kg), leading to inhibition of T effector cell activity. Poster #0353 highlighted data demonstrating significantly elevated urinary ALCAM levels in patients with LN compared to control patients without kidney disease (p<0.001). The urinary ALCAM levels varied based on the pathologic classification of LN. Over the course of the study urinary ALCAM levels declined as proteinuria improved, suggesting its potential role as a biomarker to monitor disease activity over time.

"As we generate more data in multiple settings, our conviction in the versatility, potency and potential clinical impact of itolizumab grows," said Dolca Thomas, M.D., executive vice president of research and development and chief medical officer of Equillium. "We continue to advance itolizumab in the EQUALISE trial to treat lupus nephritis, as well as in our programs for acute graft-versus-host disease and uncontrolled asthma and look forward to providing updates on these programs in the near future."

To view the poster presentations, visit the Publications & Presentations page of Equillium's website: https://www.equilliumbio.com/technology/publications-presentations/default.aspx.