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Abstract: SA-PO875

EQUALISE Type B: Clinical Results of Itolizumab, a Novel Anti-CD6 Therapy, in Subjects with Lupus Nephritis

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Kalunian, Kenneth, University of California San Diego, La Jolla, California, United States
  • Parameswaran, Sreejith, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, Tamil Nadu, India
  • Levin, Robert W., University of South Florida, Tampa, Florida, United States
  • Kopyt, Nelson P., Lehigh University, Bethlehem, Pennsylvania, United States
  • Connelly, Stephen, Equillium Inc, La Jolla, California, United States
  • Sun, Eugene, Equillium Inc, La Jolla, California, United States
  • Kim, Catherine, Equillium Inc, La Jolla, California, United States
  • Fung, Maple M., Equillium Inc, La Jolla, California, United States
  • Rathi, Manish, Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh, India
Background

Itolizumab is a first-in-class, non-depleting, monoclonal antibody against the co-stimulatory receptor CD6 that blocks its interaction with ALCAM, to inhibit Teff cell activity and trafficking. It is being evaluated to treat immuno-inflammatory diseases where T cells play a central role, including active proliferative lupus nephritis (apLN). We present results from EQUALISE (Type B; NCT04128579), a Phase 1b study of itolizumab in subjects with apLN.

Methods

17 adult subjects with apLN (ISN/RPS class III or IV with or without class V) were enrolled. All were treated with open-label itolizumab 1.6 mg/kg SC Q2W for up to 13 doses in combination with MMF (2-3g/d) and systemic corticosteroids (rapid taper to <prednisone 10mg/day by W10). Subjects had 12 weeks follow-up post dosing. Safety and efficacy were assessed.

Results

The median subject age was 34 years; 94% were female with 82% Asian; most subjects had class IV+V disease (47%). Mean duration of LN was 5.4 years with Baseline mean 24 hour urine protein of 4.9 g and eGFR of 104 ml/min/1.73m2. Treatment was completed in 11 subjects with 4 discontinuing early (3 due to adverse event (AE) and 1 due to physician decision) and 2 are still dosing.
88% of subjects experienced at least 1 AE, most common were peripheral edema and lymphopenia. At least 1 low lymphocyte count was reported by 7 subjects (41%). Serious AEs occurred in 2 subjects (12%), including dehydration and COVID-19, with none deemed related to study treatment.
Based on the 14 subjects that completed/terminated the study and had a post-baseline measure, there was a median 72% reduction in spot urine protein creatinine ratio (UPCR), resulting in high partial and complete response (PR and CR) rates (FIGURE). These responses occurred as early as prior to Week 4 on study.

Conclusion

EQUALISE Type B demonstrates that subjects with proteinuric apLN had high CR and PR rates with rapid and deep reduction in UPCR when itolizumab was added to MMF and steroids. Further controlled studies are warranted in this population at high risk of disease progression and end stage kidney disease.

Equalise Type B: % of responders at Weeks 12 & 36

Funding

  • Commercial Support – Equillium