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; Phase 3 data presented at EADV 2024

GEMINI-1: Imsidolimab (750mg and 300mg IV) Effective in Treatment of GPP Flare in GEMINI-1 & in Crossover Placebo Patients in GEMINI-2 (750mg IV)

Primary Endpoint GPPPGA 0/1 at Week 4

1. % of patients achieving GPPPGA 0/1 at Week 4 and PRS 0/1 at Week 1 in GEMINI-1 after a single IV dose of imsidolimab 750mg, 300mg, or placebo

GEMINI-2: Imsidolimab (200mg SC) Q4W Maintained Response & Prevented GPP Re-flaring Regardless of GEMINI-1 Imsidolimab Dose

Time to Loss of GPPPGA 0/1 Response
  • Imsidolimab (n=8) 0% flared vs. placebo (n=8) 62.5% flared
  • Imsidolimab maintained GPPPGA 0/1 response regardless of GEMINI-1 dose
  • Placebo crossover patients who received imsidolimab 750mg IV/200mg SC in GEMINI-2 (n=9): 77.8% maintained remission for at least 24 weeks (observational data)

2. Kaplan-Meier curve of time to loss of response with imsidolimab 200mg SC (shown by dose of imsidolimab received in GEMINI-1) and placebo every 4 weeks

Safety and Tolerability

  • Treatment-emergent adverse events (TEAE) similar across treatment groups
  • No SAEs or severe AEs in imsidolimab-treated patients
  • No cases of DRESS or GBS
  • Low incidence and no elevation of infections vs. placebo
  • 1 patient treated with 750 mg (n=30, 3%) had detectable non-neutralizing anti-drug antibodies (ADA)
  • Similar safety across both GEMINI-1 and -2

Full EADV 2024 poster and oral presentations are available here.