Positive Key Results from Phase 1b EQUALISE Study's Type B for Itolizumab in Treating Lupus Nephritis Unveiled by Equillium

Equillium, Inc., a clinical-stage biotech firm, has reported positive primary results from the Phase 1b EQUALISE study's Type B segment, which assessed the efficacy of itolizumab in lupus nephritis patients. The drug, when combined with mycophenolate mofetil/mycophenolic acid (MMF/MPA) and corticosteroids, showed significant reduction in urine protein creatinine ratio (UPCR), indicating a high rate of complete and partial remission. More than 80% of participants experienced a reduction of over 50% in their UPCR, and itolizumab was also found to have a good safety profile.
The study included 17 subjects, with 16 completing the 36-week trial. The primary focus was on changes in UPCR, with complete response defined as a decrease of 50% or more and less than 0.5-0.7 g/g, and partial response as a 50% or more reduction in UPCR. Key findings included a median UPCR reduction of approximately 73% from baseline, with 37.5% achieving complete response and 43.8% achieving partial response by week 36 or their end of study visit. The overall response rate was higher than expected when compared to standard care, similar to the Phase 3 AURORA1 study of voclosporin.
Subjects were able to reduce their systemic corticosteroids by over 80% by week 24, and itolizumab induced consistent pharmacodynamic responses, reducing T cell activity. The treatment was also associated with a reduction in absolute lymphocyte counts (ALC) without increased infection rates or other adverse effects. Most treatment-emergent adverse events were mild to moderate, with lymphopenia and peripheral edema being the most common.
Itolizumab is a novel anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway, which is crucial in modulating T cell activity in various immuno-inflammatory diseases. Equillium, which holds the rights to itolizumab through a partnership with Biocon Limited, has an exclusive agreement with Ono Pharmaceutical for its development and commercialization. The topline data is the first of two datasets that will inform Ono Pharmaceutical's decision on exercising their option to acquire itolizumab, anticipated in the latter half of 2024.

Systemic Lupus Erythematosus (SLE) is an autoimmune disorder that can affect various organs, with Lupus Nephritis (LN) being a serious complication that impacts the kidneys in 30% to 60% of SLE patients. LN can lead to end-stage renal disease and has a higher mortality rate compared to the general population.

The EQUALISE study was divided into two parts, with Type A focusing on the safety and tolerability of itolizumab in SLE patients, and Type B evaluating its clinical activity in LN patients with active proliferative disease. The study followed guidelines from the European League Against Rheumatism (EULAR) and the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA).

Equillium's pipeline includes other novel immunomodulatory assets targeting immuno-inflammatory pathways, such as EQ101 and EQ302, and a multi-cytokine platform designed to block key cytokines at the receptor level. The company is committed to developing therapies for severe autoimmune and inflammatory disorders with significant unmet medical needs. 

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