Pfizer Eczema Drug Advances; Oral BTK Inhibitor Shows Promise for Food Allergy
Pfizer's tilrekimig met its primary endpoint in a mid-stage eczema trial and will advance to late-stage testing. Separately, oral remibrutinib demonstrated rapid efficacy in treating peanut allergy in a phase II study.
U.S. drugmaker Pfizer said on Monday its experimental drug for a chronic skin disease met the main goal in a mid-stage study. The patients treated with the drug tilrekimig saw a significant reduction in symptoms after 16 weeks and the drug was well tolerated with a favorable safety profile in the study.
The drug is currently being tested in patients with moderate to severe atopic dermatitis or eczema, a skin disease which causes itching, widespread rashes and inflammation that can disrupt daily activities. Across three doses, the share of patients with strong improvement was 38.7%, 51.9% and 49.4%, which were higher than placebo.
Based on the results, Pfizer said it plans to move the drug into late-stage testing for eczema, with the trial expected to begin this year. Pfizer plans to develop the drug for asthma and chronic obstructive pulmonary disease.
In separate food allergy research, oral remibrutinib (Rhapsido) increased peanut tolerance in adults with proven allergy to it, with benefits in as little as 1 week, a phase II trial showed. After 4 weeks on the Bruton's tyrosine kinase (BTK) inhibitor, 40.0% (six of 15) of patients given the lowest 10-mg twice daily dose tolerated at least 600 mg of peanut protein -- equivalent to 2.5 peanuts. That proportion rose to half (eight of 16) in those on 25 mg twice daily and 86.7% (13 of 15) on 100 mg twice daily, whereas none were able to do so on placebo.
All six patients given just 1 week of remibrutinib at 25 mg twice daily after 3 weeks on placebo tolerated the challenge without reaction to at least 600 mg of peanut protein. The trial included 76 adults (ages 18-55) with a documented history of allergy to peanut, qualifying peanut-specific IgE, and skin prick test for peanut allergen. Baseline reaction-eliciting dose was 30 mg or less on the baseline challenge for all participants. Of the 66 patients who completed the study, 59 made it to the final efficacy analysis without being deemed noncompliant.
The only treatment approved to treat food allergies without being allergen specific is omalizumab (Xolair). Omalizumab is now FDA-approved for children one year and older, either by itself or before starting oral immunotherapy. The injection has to be given every two to four weeks – if you stop taking it, your body will revert to its allergic state.
The adverse event profile for remibrutinib was very reassuring, without worrisome signals in infections, infestations, nasopharyngitis, upper respiratory tract infection, or potential systemic effects like petechiae, blood cell count dynamics, or new liver enzyme abnormalities. Because of these results and other evidence coming in from other disease models, a phase III study in adults and adolescents with IgE-mediated food allergy probably expanding beyond peanuts is planned to start later in 2026.
Food allergy impacts 8 to 10% of the U.S. population. Oral immunotherapy, which involves taking small amounts of the food you're allergic to every day and it desensitizes your body over time, was FDA-approved in 2020.