Peanut Allergy Immunotherapy Shows Positive Results in Phase 3 Trial

November 18, 2018

Oral immunotherapy for peanut allergy could protect children against severe reactions from accidental exposure

About a year after receiving daily oral immunotherapy for severe peanut allergy, 67 percent of children in a Phase 3 trial were able to tolerate eating at least two peanuts (600 mg) without an allergic reaction, while 50 percent tolerated eating three to four peanuts (1,000 mg) without symptoms. At the start of the study, all of these children had allergic reactions after ingesting just 1/10 of a peanut (30 mg). These results of an international, randomized, double-blind, placebo-controlled trial conducted at 66 sites, including Ann & Robert H. Lurie Children’s Hospital of Chicago, were published in the New England Journal of Medicine. With nearly 500 participants (4-17 years of age), the study was the largest ever conducted for peanut oral immunotherapy, and it demonstrated a favorable safety profile.

“Our results are very exciting, showing that children with peanut allergy could tolerate considerably higher amounts of peanut than what they typically would risk ingesting through accidental exposure,” says study author Jacqueline Pongracic, MD, Head of Allergy and Immunology at Lurie Children’s and Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “The increased tolerance is hugely important since peanuts are hard to avoid and even small amounts can be deadly. If approved by the FDA, this would be the first treatment for peanut allergy we could offer our patients as protection against severe reactions from accidental exposure.”

Peanut allergy is the most common food allergy in the U.S., affecting over 1.6 million children, and it accounts for the majority of deaths related to food allergy. Currently, there are no approved treatments. The standard of care is strict elimination diet and timely administration of rescue medications in case of an allergic reaction from accidental exposure.

The immunotherapy in the study consisted of a peanut protein taken as an oral powder mixed in uncooked food. The daily dose was gradually increased for approximately six months, and then continued for the next six months at a 300 mg maintenance dose.

Adverse events were mostly mild to moderate, except for one anaphylactic event in the treatment group.

Given the positive results of this trial, the study sponsor Aimmune Therapeutics plans to submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) by the end of 2018. The immunotherapy drug has FDA Fast Track Designation, as well FDA Breakthrough Therapy Designation for peanut-allergic patients ages 4-17 years. Assuming FDA approval, the treatment could be available to patients in the second half of 2019.

If approved, this treatment would need to be taken daily to protect children with peanut allergy from life-threatening allergic reactions due to accidental exposure. However, patients would still need to avoid peanut-containing foods.

“We are conducting follow-up studies to collect more information on safety and immunologic changes as a result of this immunotherapy,” says Dr. Pongracic.

Research at Ann & Robert H. Lurie Children’s Hospital of Chicago is conducted through the Stanley Manne Children’s Research Institute. The Manne Research Institute is focused on improving child health, transforming pediatric medicine and ensuring healthier futures through the relentless pursuit of knowledge. Lurie Children’s is ranked as one of the nation’s top children’s hospitals in the U.S.News & World Report. It is the pediatric training ground for Northwestern University Feinberg School of Medicine. Last year, the hospital served more than 212,000 children from 49 states and 51 countries.