Imsidolimab

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

Intend to out-license imsidolimab in 2024 and submit comprehensive data abstract to H2 2024 medical meeting

Generalized pustular psoriasis 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

(Acute Flare) through week 4

Enrolled 45 patients across 3 arms (1:1:1)

53% who received single dose of 750mg IV imsidolimab responded:

  • Achieved GPPPGA score of 0/1 (clear or almost clear) at Week 4 primary endpoint

Compared to:

  • 13% responded on placebo (p=0.0131)
  • 53% responded if received single dose of 300mg IV imsidolimab

GEMINI-2 Phase 3 trial and top-line results

(Maintenance/Prevention) through at least 24 weeks

All 8 responding patients from GEMINI-1 who re-randomized to monthly 200mg SC imsidolimab maintained GPPPGA score of 0/1

  • None of these patients experienced a GPP flare

Compared to responding patients from GEMINI-1 that were re-randomized to placebo:

  • Only 25% maintained GPPPGA 0/1 response
  • 63% flared after being re-randomized to placebo

Safety and Tolerability

GEMINI-1 and GEMINI-2 trials demonstrated consistent, favorable safety and tolerability profile

  • No treatment-related serious adverse events (SAEs) or SAEs that lead to discontinuation in imsidolimab-treated patients
  • Low incidence and no elevation of infections vs. placebo
  • No cases reported of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre syndrome (GBS)
  • No infusion reactions reported
  • Overall incidence of anti-drug antibodies (ADA) was low and, when detected, were determined to be non-neutralizing