Anaptys Announces Positive Top-Line Phase 3 Clinical Trial Results of Imsidolimab (IL-36R) in Generalized Pustular Psoriasis (GPP)

• 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
• Plan to present comprehensive data from GEMINI-1 and top-line GEMINI-2 results at a medical meeting in H2 2024
• Intend to out-license imsidolimab in 2024
  

SAN DIEGO, Oct. 09, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced positive top-line results from its global Phase 3 GEMINI-1 trial evaluating the safety and efficacy of imsidolimab (IL-36R mAb) in patients with generalized pustular psoriasis (GPP) flares. Investigational imsidolimab met its primary endpoint in the study population achieving rapid clearance of pustulation, erythema and scaling through Week 4 after a single dose of 750mg IV imsidolimab. Top-line data also demonstrate a favorable safety and tolerability profile.

“The success of the GEMINI-1 trial highlights Anaptys’ commitment to patients and our ability to internally discover and develop differentiated antibodies,” said Daniel Faga, president and chief executive officer of Anaptys. “Moving forward, we intend to out-license imsidolimab with this compelling and competitive dataset to bring this therapy to patients living with this highly morbid condition and reallocate the potential proceeds of a transaction to further invest in the broad development of our best-in-class immune cell modulators, including our checkpoint agonists, in autoimmune and inflammatory diseases.”

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. The registration-enabling GEMINI-1 trial in GPP, which recruited 45 patients, is the first randomized, double-blind, placebo-controlled trial to use the composite endpoint of Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) at Week 4 as its primary assessment. The GPPPGA assessment, representing a stringent and comprehensive characterization of disease severity, required satisfying an overall clinical response score of 0/1 (clear or almost clear) collectively across each GPP disease attribute, including pustulation, erythema and scaling.