Imsidolimab is an IgG4 antibody that inhibits the function of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogenesis of inflammatory diseases, including GPP

Generalized pustular psoraisis disease overview

GPP is a systemic, life-threatening inflammatory disease characterized by widespread pustules

  • Associated with unregulated IL-36 signaling
  • Patients have a high fever and elevated levels of serum CRP and inflammatory cytokines (e.g., IL-8)
  • Severe GPP patients can die from cardio-pulmonary failure, exhaustion, toxicity and infection

GPP ICD-10 diagnostic code analysis by IQVIA assessed US prevalence during 2017-2019 timeframe

  • ~37,000 unique patients diagnosed at least once
  • ~15,000 unique patients diagnosed two or more times

FDA has granted ODD for treatment of GPP

GEMINI-1 Phase 3 trial and top-line results

Announced October 2023

Registration-enabling, four week, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of imsidolimab (IL-36R) in patients with GPP, irrespective of mutational status

Top-line results –

  • 53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131)
  • Demonstrated favorable safety and tolerability with no SAEs, low incidence and no increase of infections vs. placebo and no cases of DRESS or Guillain-Barre in imsidolimab-treated patients
  • Only one of 30 (3.3%) imsidolimab-treated patients had detectable ADA, which were non-neutralizing
  • Intend to out-license imsidolimab in 2024

GEMINI-2 Phase 3 trial

  • Patients who were rescued or completed the GEMINI-1 trial are subsequently being enrolled in GEMINI-2, the second Phase 3 trial for imsidolimab in GPP
  • Patients receive monthly doses of 200mg subcutaneous imsidolimab or placebo depending upon whether they are responders, partial responders or non-responders to treatment under GEMINI-1