Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis - Seite 2

Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:

• Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
• Percent reduction from baseline in median spot UPCR is ~73%.
• Best clinical response observed by week 36 or their EOS visit:
  • 6 of 16 (37.5%) subjects achieved CR (UPCR < 0.7 g/g)
  • Additional 7 of 16 (43.8%) subjects achieved PR (UPCR > 50% reduction)
• There was a greater overall response rate (ORR) achieved in patients receiving itolizumab by 12 and 28 weeks than expected compared to the ORR in patients receiving standard of care alone using data generated from the Accelerating Medicines Partnership (AMP) Lupus Network. Results are comparable to those observed in the Phase 3 AURORA1 study of voclosporin (ORR 70% at 6 and 12 months in active treatment).
• Consistent with the decline in UPCR overtime, subjects were able to taper their systemic corticosteroids over the course of the study with >80% reduction by Week 24.
• Itolizumab induced consistent pharmacodynamic responses in patients reducing the levels of cell surface CD6 on T cells, which is known to reduce T cell activity.
• Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
• As noted in other studies of drugs whose mechanism leads to reductions in ALC, such as the S1P modulators, the reduction in ALC observed here was not associated with increased rates of infection or other adverse clinical signals.
• The majority of TEAEs were assessed as mild (Grade 1) or moderate (Grade 2) in severity, with the two most common TEAEs being lymphopenia and peripheral edema. Two subjects had at least one serious adverse event, none of which were related to study treatment.

About Systemic Lupus Erythematosus (SLE) & Lupus Nephritis (LN)

SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. LN is a serious complication of SLE, occurring in approximately 30% – 60% of individuals with SLE. LN involves the body’s own immune system attacking the kidneys, causing inflammation and significantly reducing kidney function over time. LN is associated with an increase in mortality compared with the general population and may lead to end-stage renal disease.