Anaptys Announces Positive Top-Line Phase 3 Clinical Trial Results of Imsidolimab (IL-36R) in Generalized Pustular Psoriasis (GPP) - Seite 2

“GPP is an unpredictable and potentially life-threatening skin disease with systemic symptoms,” said Professor Hervé Bachelez, M.D., Ph.D., Hôpital Saint-Louis, Paris, one of the world’s leading experts on GPP. “Achieving positive top-line results utilizing the GPPPGA composite endpoint in this well conducted, randomized controlled, global trial, along with a compelling safety profile, represents the potential for a single dose of imsidolimab to predictably provide relief for patients living with this burdensome disease.”

Imsidolimab Met Primary Endpoint Achieving Rapid Clearance of GPP Through Week 4 After a Single Dose

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).

Additionally, 66.7% (10/15) of placebo patients exited GEMINI-1 early, crossed-over to GEMINI-2 and were eligible to receive rescue therapy with a single dose of 750mg IV imsidolimab.

Imsidolimab Was Well Tolerated Through End of Study

• All AEs reported in imsidolimab-treated patients were mild or moderate and balanced across imsidolimab-treated vs. placebo patients
• No SAEs or severe AEs reported in imsidolimab-treated patients
• No cases reported of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre syndrome (GBS)
• Low incidence and no elevation of infections vs. placebo
• No infusion reactions reported
• One of 30 (3.3%) imsidolimab-treated patients had detectable anti-drug antibodies, which were non-neutralizing

Anaptys plans to present comprehensive data from GEMINI-1 and top-line GEMINI-2 results at a medical meeting in H2 2024. Furthermore, the company anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) by Q3 2024.

“We are excited that these top-line results from the Phase 3 GEMINI-1 trial support that a single infusion of imsidolimab is efficacious and well tolerated,” said Paul Lizzul, M.D., Ph.D., chief medical officer of Anaptys. “We would like to thank the patients, investigators and study personnel for their participation in this trial. We look forward to engaging with FDA and plan to submit a BLA by Q3 2024.”

GEMINI-1 Trial Design and Patient Demographics

Anaptys’ Phase 3 registration-enabling GEMINI-1 clinical trial was a 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.