US biopharmaceutical company Pfizer Inc (NYSE:PFE) on Thursday reported positive Phase 2 results for investigational tilrekimig (PF-07275315) in adults with moderate-to-severe atopic dermatitis, with the study meeting its primary endpoint at Week 16.
Across all evaluated doses, tilrekimig produced a statistically significant increase in the percentage of patients achieving EASI-75, defined as at least a 75% reduction in the Eczema Area and Severity Index, compared with placebo.
In Stage 1, 62.5% of patients receiving 450 mg every two weeks achieved EASI-75 versus 19.9% for placebo.
In Stage 2, EASI-75 rates were 58.5%, 61.0% and 47.8% for 400 mg, 200 mg and 50 mg every four weeks, respectively, compared with 9.1% for placebo.
Tilrekimig also improved vIGA 0/1 outcomes, with 30.3% of patients in Stage 1 achieving clear or almost clear skin versus 11.8% for placebo, while 26%-27% of patients across Stage 2 dosing groups achieved the endpoint versus 0% for placebo.
Exploratory analyses showed greater reductions in itch among patients receiving tilrekimig, including treatment differences of 35.3% for the 400 mg group and 43.6% for the 200 mg group.
Pfizer said tilrekimig was well tolerated, with no dose-dependent safety signals and treatment-emergent adverse-event rates generally comparable with placebo; no serious adverse events related to tilrekimig were reported in either stage.
Tilrekimig is an investigational trispecific antibody designed to inhibit IL-4, IL-13 and TSLP, with an anticipated half-life of about 37 days supporting monthly administration.
Pfizer's Phase 3 programme is underway in atopic dermatitis and asthma, while an ongoing Phase 2b/3 study is evaluating tilrekimig in chronic obstructive pulmonary disease.
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