Biologics

Biologic drugs are often made from antibody proteins that attack key steps in a biological pathway by binding to pathway molecules and interfering with their activity. In the case of food allergy, the pathways of interest lead from the mistaken targeting of food proteins by immune system defenses to the reaction symptoms that result. Biologic drugs can be used in combination with allergen-specific immunotherapies or on their own:

• Small Phase II trials that study safety and effectiveness have combined OIT with omalizumab (Xolair®), an injectable asthma medication that targets allergy-associated IgE antibodies.
  • In a 2017 study, 83 percent of children receiving OIT plus omalizumab were able to pass an oral food challenge after 28 weeks of multi-food OIT, compared to 33 percent of children receiving multi-food OIT plus placebo. The omalizumab group also had fewer reactions during OIT.
  • A 2015 FARE-funded study of milk OIT plus omalizumab found that omalizumab lowered the frequency and severity of reactions during OIT and allowed patients to desensitize more quickly, but did not significantly change the percentage of patients that become desensitized.
  • In a 2016 study of peanut OIT plus omalizumab, also funded by FARE, most placebo-treated patients were unable to tolerate the rapid desensitization and left the study prior to oral food challenge, while most omalizumab-treated patients were able to continue treatment and eventually tolerated the challenge dose.
• A Phase II peanut OIT trial is recruiting to compare AR101 (Palforzia®) with AR101 plus dupilumab (Dupixent®), a biologic drug that targets the interleukin-4 receptor, whose activity impacts IgE antibody production and immune cell functions associated with allergy. Dupilumab has already been approved as a treatment for moderate to severe eczema.
• Clinical trials are also ongoing to show whether biologic drugs like omalizumab or dupilumab can protect patients independent of OIT, by raising the threshold for reaction. Promising results have been reported from a small recent study of the biologic drug etokimab, which blocks interleukin-33, a signaling molecule that can increase the activity of allergy-associated cells and molecules. In a Stanford University study of 20 people with severe peanut allergies, 11 of 15 patients (73 percent) could tolerate 275 mg of peanut protein two weeks after receiving one injection etokimab, while none of the five patients on placebo could tolerate this dose. At day 45, six weeks after injection, 4 of 7 etokimab-treated patients (57 percent) could still tolerate the 275-mg peanut protein challenge dose. Larger studies are planned.