On September 27, 2022, Equillium, Inc. (“Equillium,” “the Company,” “we,” “us,” or “our”) reported interim results from the Type B portion of the EQUALISE study evaluating itolizumab, a first-in-class anti-CD6 monoclonal antibody selectively targeting the CD6-ALCAM pathway, in patients with lupus nephritis (“LN”).
The Type B portion of the EQUALISE study in patients with active proliferative LN is evaluating the safety, tolerability and clinical activity of subcutaneous delivery of itolizumab. Patients must present with greater than 1 gram of proteinuria and positive biopsy 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 (MMF/MPA), and patients may receive pulse systemic corticosteroids that are rapidly tapered.
For this interim analysis, 13 subjects have been enrolled and dosed, with 11 subjects reaching at least 12 weeks of treatment and 6 subjects reaching 28 weeks or the end of study (“EOS”). Based on published guidelines for the management of lupus nephritis from the European League Against Rheumatism (“EULAR”) and European Renal Association-European Dialysis and Transplant Association (“ERA-EDTA”), clinical activity assessments in this study are focused on the change in urine protein creatinine ratio (“UPCR”) from baseline; proportion of apLN subjects with a complete response (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 (PR), defined as 50% or greater reduction in UPCR.
Key findings from the interim analysis of the Type B portion of the EQUALISE study in lupus nephritis:
| | • | | Subjects were highly proteinuric: baseline mean UPCR of 5.8 g/g |
| | • | | Clinically meaningful responses were observed: |
| | • | | 3 of 6 (50%) subjects achieved CR (UPCR < 0.7 g/g) |
| | • | | 2 of 6 (33%) subjects achieved PR (UPCR > 50% reduction) |
| | • | | 4 of 6 (67%) subjects achieved greater than 80% reduction in UPCR |
| | • | | In all subjects receiving more than one dose: |
| | • | | 8 of 12 (67%) subjects achieved greater than 50% reduction in UPCR |
| | • | | Average reduction of 60% in UPCR (over 3g of proteinuria) |
| | • | | Subjects titrated steroid dose to < 7.5 mg/day consistent with EULAR/ERA-EDTA recommendations |
| | • | | Itolizumab was generally safe and well tolerated with no drug related serious adverse events or treatment discontinuations |
Data reported from the Type B portion of the EQUALISE study are preliminary and subject to change as more patient data become available.
Top-line data from the Type B portion of the EQUALISE study in patients with lupus nephritis is expected to be announced mid-2023.
In connection with the report of the interim results from the EQUALISE study, the Company referred to the presentation attached hereto as Exhibit 99.1, which is incorporated herein by reference.
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