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Pfizer’s tilrekimig delivers Phase II skin clearance ahead of dupilumab head-to-head

Pfizer’s tilrekimig delivers Phase II skin clearance ahead of dupilumab head-to-head

Pfizer presented detailed Phase II data for tilrekimig in adults with moderate-to-severe atopic dermatitis (AD), showing statistically significant EASI-75 response rates across all evaluated doses versus placebo at Week 16. The findings expand on positive topline results first disclosed in March 2026.

Tilrekimig is an investigational trispecific antibody designed to bind IL-4, IL-13, and thymic stromal lymphopoietin (TSLP) simultaneously, targeting both upstream and downstream drivers of type 2 inflammation. Its approximately 37-day half-life is intended to support once-monthly administration.

In Stage 1 of the randomized, double-blind, placebo-controlled trial, 62.5% of patients receiving subcutaneous tilrekimig 450 mg every two weeks achieved EASI-75 at Week 16 versus 19.9% on placebo (p=0.0008). In Stage 2, EASI-75 rates were 58.5%, 61.0%, and 47.8% across the 400 mg, 200 mg, and 50 mg every-four-week groups, respectively, versus 9.1% on placebo (all p<0.003). Across the monthly-dose groups, 26%–27% of patients achieved vIGA 0/1 versus none on placebo.

Tilrekimig was generally well tolerated, with no dose-dependent safety signal and no serious adverse events considered related to treatment. Pfizer said conjunctivitis and injection-site reaction rates at doses up to 400 mg every four weeks were lower than rates reported with IL-4Rα inhibitors and comparable with placebo, although the comparison was not head-to-head.

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Approved biologics for moderate-to-severe AD include Sanofi and Regeneron's Dupixent (dupilumab), which blocks IL-4Rα, and the IL-13 antibodies Eli Lilly's Ebglyss (lebrikizumab-lbkz) and LEO Pharma's Adbry (tralokinumab-ldrm). Tilrekimig's trispecific design is intended to provide broader type 2 inflammatory pathway blockade by adding TSLP inhibition to IL-4 and IL-13 targeting.

Pfizer has initiated three Phase III studies of tilrekimig — two in atopic dermatitis, including one with dupilumab as an active comparator, and one in asthma — and is also advancing an ongoing Phase IIb/III study in chronic obstructive pulmonary disease.


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