Remibrutinib Enables Peanut Tolerance in as Little as 1 Week, With Robert Wood, MD

Remibrutiib has demonstrated striking early efficacy data in IgE-mediated peanut allergy, with just 1 week of treatment enabling 88% of adult participants to tolerate a previously reactive dose in new phase 2 data presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting held in Philadelphia, Pennsylvania, from February 27 to March 2.

HCPLive sat down with Robert A. Wood, MD, Chief of the Eudowood Division of Pediatric Allergy and Immunology at Johns Hopkins Children's Center and Professor of Pediatrics at the Johns Hopkins University School of Medicine, who presented the data at the meeting, to learn more about the promising findings and what they may suggest about BTK inhibition’s potential for modifying food allergy.

The phase 2 study evaluated 3 dose levels of remibrutinib, an oral, highly selective BTK inhibitor, versus placebo in 59 adults with IgE-mediated peanut allergy confirmed by double-blind, placebo-controlled oral food challenge (DBPCFC) at screening. The primary endpoint was tolerating a single dose of ≥600 mg peanut protein without dose-limiting symptoms during DBPCFC at week 4. Four weeks of treatment across the 10, 25, and 100 mg twice-daily dose arms produced estimated response rates (ERR) of 0.41, 0.52, and 0.84, respectively, all superior to placebo. Most striking was the 1-week arm — in which participants received 3 weeks of placebo run-in followed by just 1 week of remibrutinib 25 mg twice daily — which yielded an ERR of 0.88, the highest of any arm in the study. Remibrutinib was well tolerated across all arms with no serious adverse events.

Wood contextualized the mechanism and implications for a field where treatment speed has long been a limiting factor. Remibrutinib works upstream of the allergen-specific pathway, targeting mast cells directly — the final effector cell in IgE-mediated allergic reactions regardless of the triggering allergen. That mechanism carries 2 significant clinical implications: first, the drug is likely to be effective across all food allergens, not just peanut, making it potentially well-suited to the 60–80% of food-allergic patients who react to multiple foods simultaneously. Second, the 1-week onset raises the possibility of intermittent rather than continuous use — providing targeted protection around specific high-risk exposures such as travel or medical procedures, rather than requiring year-round maintenance dosing.

On the regulatory pathway, Wood noted that remibrutinib is already approved for chronic spontaneous urticaria, clearing an initial safety bar for long-term use, though he flagged that the dose likely required for food allergy efficacy appears higher than the approved urticaria dose, and that dose-dependent safety characterization will be a key focus of the phase 3 trial — which is now underway in adults and adolescents down to age 12, with the question of whether it will extend to younger children dependent on the safety data that emerge from those older cohorts.

“The speed is again, pretty remarkable, and opens the possibility that this treatment might be used intermittently rather than continuously. So if a if a patient with severe food allergy didn't want to be on a long term maintenance medicine, but wanted [short-term] protection… say, for travel,” Wood said.

Wood’s disclosures include Aimmune, ALK, DBV Technologies, FARE, Genentech, NIAID, Novartis, Regeneron, Siolta, and Aravax.

References

1. Derman C. FDA Approves Remibrutinib for Chronic Spontaneous Urticaria. HCPLive. Article. September 30, 2025. https://www.hcplive.com/view/fda-approves-remibrutinib-chronic-spontaneous-urticaria

2. Wood R, Tan R, Shah R, et al. Efficacy and safety of remibrutinib, a Bruton’s tyrosine kinase inhibitor, for individuals with IgE-mediated peanut allergy. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Abstract #563