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Abstract: PO1624

Itolizumab, a Novel Anti-CD6 Antibody, in Systemic Lupus Patients with Proteinuria: An Interim Subgroup Analysis from EQUALISE, a Phase 1b Study

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Putterman, Chaim, Yeshiva University Department of Medicine, Bronx, New York, United States
  • Furie, Richard, Northwell Health, New Hyde Park, New York, United States
  • Radhakrishnan, Jai, Columbia University, New York, New York, United States
  • Mathur, Vandana S., Equillium Inc, La Jolla, California, United States
  • Polu, Krishna Reddy, Equillium Inc, La Jolla, California, United States
  • Connelly, Stephen, Equillium Inc, La Jolla, California, United States
  • Rothman, Joel M., Equillium Inc, La Jolla, California, United States
  • Chinn, Leslie, Equillium Inc, La Jolla, California, United States
  • Nanayakkara, Nuwan, Equillium Inc, La Jolla, California, United States
  • Fung, Maple M., Equillium Inc, La Jolla, California, United States
  • Ng, Cherie T., Equillium Inc, La Jolla, California, United States
  • Thomas, Dolca, Equillium Inc, La Jolla, California, United States
  • Kalunian, Kenneth, University of California San Diego Health Sciences, La Jolla, California, United States
Background

CD6 is a co-stimulatory receptor that is expressed on T cells. The CD6 ligand, ALCAM, is found on antigen presenting cells, as well as epithelial and endothelial cells. Itolizumab (ITO), a humanized IgG1 monoclonal antibody that binds CD6 and inhibits the interaction of CD6 and ALCAM, inhibits T cell activity and trafficking. ITO is being evaluated as a treatment for systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Methods

EQUALISE (NCT04128579) is a Phase 1b US study of ITO in SLE patients with and without active proliferative LN. Part A enrolled SLE patients (N = 34) who had received ≥ 1 SLE treatment but did not have active proliferative LN. Patients received 2 open-label doses of 0.4 to 3.2 mg/kg each SC on Day 1 and Day 15 with follow up through Day 57.

Results

A subgroup analysis of 16 subjects with Baseline (mean of screening and Day 1) urine protein/creatinine ratio (UPCR) > 100 mg/g was performed. Mean age was 55, 94% were female; 81% white and the mean years since SLE diagnosis was approximately 11. Mean baseline eGFR was 95 ml/min/1.73m2 and UPCR was 272 mg/g (range 100-1505).
On Day 29, a geometric mean decrease in UPCR of ~45% was observed in these 16 subjects with greater decline seen for subjects with higher Baseline UPCR values. By Day 57, 6 weeks post treatment the decrease was ~34% from Baseline (Figure). Notable is one subject (1.6 mg/kg dose) who had significant Baseline UPCR of 1505 mg/g, by Day 29 the UPCR had declined to 974 mg/g, and at Day 57 declined to 857 mg/g.
SC treatment was well tolerated. Of the 6 subjects who had a total of 12 treatment-emergent adverse events (AEs), 4 were from the 3.2 mg/kg cohort. All AEs were mild or moderate in severity.

Conclusion

Patients with SLE and mild baseline proteinuria tolerated ITO treatment well. EQUALISE Part B will further explore the safety and efficacy of ITO in LN patients.

Urine protein: creatinine ratio over time (mean±SEM) and individual subjects

Funding

  • Commercial Support