AnaptysBio Announces Positive Results from Phase 3 Trial of Imsidolimab for Generalized Pustular Psoriasis

AnaptysBio, a clinical-stage biotechnology company, has recently shared positive top-line results from its global Phase 3 GEMINI-1 trial evaluating the efficacy and safety of imsidolimab (IL-36R mAb) in patients with generalized pustular psoriasis (GPP) flares. The investigational imsidolimab met its primary endpoint, demonstrating rapid clearance of pustulation, erythema, and scaling after a single dose of 750mg IV imsidolimab.

The GEMINI-1 trial, which enrolled 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 results showed that 53.3% of patients who received a single dose of imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4, compared to 13.3% of patients on placebo.

Generalized pustular psoriasis is a rare and potentially life-threatening skin disease with systemic symptoms. Professor Hervé Bachelez, one of the world’s leading experts on GPP, expressed his excitement about the positive results, stating that a single dose of imsidolimab could provide relief for patients living with this burdensome disease.

AnaptysBio plans to present comprehensive data from the GEMINI-1 trial and top-line results from the GEMINI-2 trial at a medical meeting in the second half of 2024. The company also intends to file a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) by the third quarter of 2024.

Daniel Faga, the president and CEO of AnaptysBio, emphasized the company’s commitment to patients and its ability to internally discover and develop differentiated antibodies. Faga also mentioned the intention to out-license imsidolimab based on the compelling and competitive dataset, with the potential proceeds being reinvested in the development of their best-in-class immune cell modulators for autoimmune and inflammatory diseases.

The positive results from the Phase 3 trial highlight AnaptysBio’s dedication to advancing innovative immunology therapeutics and bringing much-needed relief to patients suffering from generalized pustular psoriasis. With the potential approval of imsidolimab, there is hope for a new treatment option for this challenging condition.