Pfizer reports positive Phase 2 results for the trispecific antibody tilrekimig in moderate-to-severe atopic dermatitis, achieving significant EASI-75 responses with a favourable safety profile.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Pfizer Inc. has reported positive topline results from a Phase 2 clinical trial (NCT05995964) evaluating the investigational trispecific antibody tilrekimig (PF-07275315) in adults with moderate to severe atopic dermatitis. The study met its primary endpoint, demonstrating a statistically significant improvement in the proportion of participants achieving ≥ 75% reduction in the Eczema Area and Severity Index (EASI-75) at Week 16 compared with placebo.
In the dose-ranging Stage 2 portion of the study, tilrekimig showed strong efficacy across monthly dosing regimens. The placebo-adjusted rates of patients achieving EASI-75 were 38.7% with the low dose, 51.9% with the middle dose, and 49.4% with the high dose. According to Pfizer, the results from the two highest dose levels suggest potentially meaningful improvements compared with currently approved biologic standard-of-care therapies for atopic dermatitis.
Tilrekimig is an investigational trispecific antibody designed to simultaneously inhibit interleukin-4 (IL-4), interleukin-13 (IL-13), and thymic stromal lymphopoietin (TSLP). By targeting multiple pathways involved in Type 2 (Th2) inflammation, the therapy is being developed as a potential once-monthly treatment for several chronic inflammatory diseases without affecting receptors on healthy cells.
“We are encouraged by the topline Phase 2 results for tilrekimig, which show that combining the potent inhibition of IL-4/13 and TSLP pathways has the potential to deliver improved efficacy over the standard of care for atopic dermatitis,” said Mike Vincent, Chief Inflammation & Immunology Officer at Pfizer. He added that the company plans to advance a broad development program for the candidate across multiple Th2-mediated conditions including asthma and chronic obstructive pulmonary disease (COPD).
The therapy demonstrated a favourable safety profile with no dose-dependent safety signals. Overall adverse event rates were comparable to placebo. The most commonly reported events included infections and infestations, skin and subcutaneous tissue disorders, general disorders, and injection-site reactions.
Three serious adverse events were reported but were considered unrelated to treatment. Notably, the frequency of conjunctivitis observed in the study was lower than rates reported with IL-4 receptor alpha inhibitors.
The ongoing randomized, double-blind, placebo-controlled Phase 2 trial is structured in four overlapping stages. Stage 1 evaluated a high dose of tilrekimig and a separate investigational trispecific antibody, ompekimig (PF-07264660), which targets IL-4, IL-13, and IL-33; both met the primary endpoint.
Stage 2 assessed dose-ranging regimens of tilrekimig. Stage 3 is currently enrolling patients who previously received biologic therapies, while Stage 4 is evaluating dose ranges for ompekimig.
Beyond atopic dermatitis, Pfizer is also studying tilrekimig in a Phase 2 trial in asthma and recently initiated a Phase 2b/3 study in COPD. Planning for a Phase 3 program in atopic dermatitis is underway, with a pivotal trial expected to begin later this year.
Detailed results from the Phase 2 study are expected to be presented at a future medical meeting and submitted to a peer-reviewed journal.
Atopic dermatitis is a chronic inflammatory skin disease driven by Type 2 immune responses and represents the most common form of eczema. The condition is characterized by persistent itching, rashes, pain, and sleep disruption, significantly affecting patients’ quality of life. Despite the availability of several therapies, many patients do not achieve adequate disease control, highlighting the ongoing need for new treatment options.
Reference
Pfizer’s Phase 2 Study of Trispecific Antibody Positive in Moderate to Severe Atopic Dermatitis, 09 March 2026, Pfizer’s Phase 2 Study of Trispecific Antibody Positive in Moderate to Severe Atopic Dermatitis | Pfizer
A Study to Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate to Severe Atopic Dermatitis, ClinicalTrials.gov ID NCT05995964, https://clinicaltrials.gov/study/NCT05995964
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.