Pfizer reports tilrekimig Phase 2 trial success

• Pfizer (NYSE:PFE) reported that investigational tilrekimig met the primary endpoint in a Phase 2 atopic dermatitis study, increasing EASI-75 responses versus placebo.
• Across evaluated doses, EASI-75 response rates ranged from 47.8% to 62.5% compared with placebo rates of 9.1% to 19.9%.
• Pfizer has started Phase 3 trials of tilrekimig in atopic dermatitis and asthma and is advancing a Phase 2b/3 COPD study.

Pfizer (NYSE:PFE) reported Phase 2 results showing that investigational tilrekimig achieved its primary endpoint by producing statistically significant increases in EASI-75 responses compared with placebo at Week 16 in adults with moderate-to-severe atopic dermatitis.

The randomized study evaluated multiple dosing regimens of tilrekimig, including 450 mg every two weeks and 400 mg, 200 mg and 50 mg every four weeks, with all evaluated doses showing higher EASI-75 response rates than placebo.

"Tilrekimig is a promising investigational medicine in Pfizer’s inflammation and immunology pipeline as we seek to pursue next-generation biologics that address persistent unmet medical needs," said Pfizer Chief Inflammation & Immunology Officer Michael Vincent, M.D., Ph.D.

In Stage 1, 62.5% of patients receiving tilrekimig 450 mg every two weeks achieved EASI-75 compared with 19.9% for placebo, while Stage 2 results showed 58.5%, 61.0% and 47.8% response rates for the 400 mg, 200 mg and 50 mg every-four-week groups, respectively.

Tilrekimig also showed improvements in clear or almost clear skin assessments and itch reduction measures, while Pfizer reported treatment-emergent adverse event rates were comparable between treatment groups and placebo with no serious adverse events related to tilrekimig in the first two study stages.

Pfizer stated that tilrekimig is an investigational trispecific antibody designed to target IL-4, IL-13 and TSLP pathways, with Phase 3 studies underway in atopic dermatitis and asthma and a Phase 2b/3 study ongoing in chronic obstructive pulmonary disease.