Drug major Pfizer, Inc. (PFE) Monday announced positive topline results from a Phase 2 study investigating tilrekimig (PF-07275315) in adults with moderate to severe atopic dermatitis. The company noted that phase 3 planning for atopic dermatitis is ongoing, with a pivotal study on track to start this year.
In preliminary activity, Pfizer shares were trading at $26.72, down 1.15%.
A chronic Type 2 (Th2) inflammatory skin condition, Atopic dermatitis affects people of all ages and genders.
Tilrekimig is an investigational trispecific antibody, with the potential to be a once-monthly treatment option for multiple chronic inflammatory conditions driven by an overactive Type 2 (Th2) immune response, without affecting receptors on healthy cells.
The Phase 2 study is an ongoing randomized, double-blind, placebo-controlled trial in adults with moderate to severe atopic dermatitis. It is being conducted in four overlapping stages.
The company noted that the study met its primary efficacy endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75 (75% reduction in the Eczema Area and Severity Index) at Week 16, compared to placebo.
In Stage 2 of the study, which evaluated monthly dosing regimens, tilrekimig showed competitive efficacy.
According to the firm, the two highest dose levels tested with tilrekimig strongly suggest potentially meaningful improvements to approved standard of care biologics.
In the trial, Tilrekimig was well-tolerated with a favorable safety profile and no dose dependent safety signals. Adverse event rates were comparable to placebo.
The company said it plans to submit detailed results from the Phase 2 study of tilrekimig to a future medical meeting and a peer-reviewed journal. Pfizer plans to share results from the ongoing portions of the study in the future, pending completion.
In addition to the ongoing trial in atopic dermatitis, Pfizer is studying tilrekimig in an ongoing Phase 2 study in asthma. The company also recently initiated a Phase 2b/3 study of tilrekimig in chronic obstructive pulmonary disease or COPD.
Mike Vincent, Chief Inflammation & Immunology Officer at Pfizer, said, "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. 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."
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