AnaptysBio Inc ANAB released topline results from its global Phase 3 GEMINI-1 trial of imsidolimab (IL-36R mAb) in patients with generalized pustular psoriasis (GPP) flares.
During a GPP flare, individuals experience the sudden eruption of painful pustules. These pustules appear over large areas of the skin, accompanied by redness, severe itchiness, and dry, cracked, or scaly skin.
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.
Topline data also demonstrate a favorable safety and tolerability profile.
Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) provides a comprehensive characterization of disease severity that requires satisfying an overall clinical response score of 0/1 (clear or almost clear).
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 for rescue therapy with a single dose of 750mg IV imsidolimab.
Anaptys plans to present comprehensive data from GEMINI-1 and topline GEMINI-2 results at a medical meeting in H2 2024.
The company anticipates filing a biologics license application with the FDA by Q3 2024.
Price Action: ANAB shares are up 16.9% at $22.50 during the premarket session on the last check Monday.
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