Global pharma giant Pfizer has reported promising topline results from its Phase 2 study of tilrekimig, an investigational trispecific antibody for adults with moderate to severe atopic dermatitis. 

 

The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75 — a ≥75% reduction in the Eczema Area and Severity Index — at Week 16 versus placebo.

 

In Stage 2, which tested monthly dosing, tilrekimig showed competitive efficacy: Low dose: 38.7%; Middle dose: 51.9%; High dose: 49.4%

 

“The two highest dose levels tested with tilrekimig strongly suggest potentially meaningful improvements to approved standard of care biologics,” Pfizer said.

 

Tilrekimig targets interleukin-4 (IL-4), interleukin-13 (IL-13), and thymic stromal lymphopoietin (TSLP), potentially offering a once-monthly option for chronic inflammatory conditions driven by an overactive Type 2 (Th2) immune response, without affecting 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. 

 

“We plan to advance a broad clinical development program for tilrekimig, a potential first-in-class trispecific antibody discovered at Pfizer, in atopic dermatitis and other Th2-mediated inflammatory diseases including asthma and COPD.”

 

The drug was well-tolerated, with adverse events comparable to placebo. The most common side effects included infections, skin reactions, and administration site issues. Three serious adverse events occurred, all deemed unrelated to treatment. Notably, conjunctivitis rates were lower than those seen with IL-4 receptor alpha inhibitors.

 

The Phase 2 study is ongoing across four overlapping stages, including testing tilrekimig in biologic-experienced patients and comparing it to ompekimig, another trispecific antibody targeting IL-4, IL-13, and IL-33.

 

Beyond atopic dermatitis, Pfizer is studying tilrekimig in asthma and has recently launched a Phase 2b/3 trial in chronic obstructive pulmonary disease (COPD). Phase 3 planning for atopic dermatitis is underway, with a pivotal study expected to start this year.