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Allergy Drug Shown to Allow Eating Small Peanut Amounts

Peanuts

(National Institute of Food and Agriculture, USDA)

7 March 2016. A new drug was shown in a clinical trial to allow most children and teens with food allergies to eat peanuts in small quantities. The results of the intermediate-stage trial were reported yesterday at the annual meeting of American Academy of Allergy, Asthma and Immunology in Los Angeles.

Allergies to peanuts and other foods are a result of the body’s immune system misinterpreting certain foods as pathogens, and responding by the release of histamines, chemicals in the body causing the allergy symptoms. In most cases, the symptoms are mild, such as runny nose and itching, but people with peanut allergies face a real and elevated risk of anaphylaxis, a life-threatening condition constricting airways, swelling the throat, and causing a sharp drop in blood pressure. Food Allergy Research and Education says some 15 million people in the U.S. and 17 million people in Europe have a food allergy, with growing numbers of people reporting an allergy.

The study, led by pediatrician J. Andrew Bird of UT Southwestern Medical Center in Dallas, tested a compound code-named AR101 developed by the biopharmaceutical company Aimmune Therapeutics in Brisbane, California. The company’s technology known as Codit exposes people with food allergies to increasing amounts of the allergens over a period of months, thereby desensitizing the individuals to the allergen. Codit, says Aimmune, enhances conventional oral immunotherapies by precisely controlling the amount of offending food protein ingested by people with food allergies and establishing treatment routines that start with very small amounts and gradually increasing the amounts over time.

AR101, is a treatment designed to provide people with peanut allergies convenient and consistent concentrations of peanut proteins, as capsules in dosages from 0.5 to 300 milligrams for desensitization and eventually maintenance therapies. The clinical trial tested AR101 with 40 individuals, age 4 to 21, with peanut allergies at 8 sites in the U.S. who took part in the earlier safety study. During the earlier study, participants took increasing doses of AR101 to build their tolerance levels of the highest dosage, 300 milligrams.

In the new study, participants were given 300 milligrams of AR101 for 12 weeks, as part of a maintenance therapy, which desensitizes individuals with allergies to small quantities (250 to 300 milligrams) of peanut protein, equivalent to about 1 peanut kernel, an amount often encountered in accidental exposure. Study participants then were randomly asked to ingest three quantities of peanut protein: 443, 1,043, and 2,043 milligrams.

The results show all participants were able to tolerate 443 milligrams of protein, while nearly all (90%) could tolerate 1,043 milligrams. Fewer participants but still a majority, 60 percent, tolerated the largest peanut protein quantity — 2,043 grams — equivalent to 7 or 8 peanuts.

The authors reported no serious adverse effects during the trial. During the earlier phase of the study, 5 participants needed to drop out from gastrointestinal side effects, which the company says were resolved in 2 weeks. However, 2 participants needed injections of epinephrine, an emergency treatment for allergic reactions.

Aimmune is recruiting participants for a late-stage clinical trial of AR101 with 500 participants up to age 55, at 16 sites in the U.S. The study will test AR101 versus a placebo as protection against various quantities of peanut protein, beginning at 1,043 milligrams. Participants receiving a placebo will be given inactive substances, not peanut protein.

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