(USDA.gov)
19 Nov. 2018. Final results from a clinical trial show a preventive treatment desensitizes children and adolescents with peanut allergies against reaction-causing proteins in peanuts for one year. The clinical study’s findings, reported yesterday in the New England Journal of Medicine, also show the treatment code-named AR101 by Aimmune Therapeutics, has no statistically reliable effects among adults with peanut allergies, and results in a 2 percent rate of serious adverse effects.
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. including nearly 6 million children, have a food allergy, with growing numbers of people reporting an allergy.
Aimmune Therapeutics, in Brisbane, California, develops a form of immunotherapy for food allergies, starting with peanuts. The company’s technology known as Codit exposes people with food allergies to increasing amounts of the allergens over 6 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.
The late-stage clinical trial tested Aimmune’s AR101 as a powder given in capsules and sachets to 496 children age 4 to 17 with peanut allergies, and a separate group of 55 adults age 18 to 49, at 69 sites in the U.S., Canada, and Europe. Participants were randomly assigned to receive either AR101 or a placebo in similar forms, first in increasing doses to build the tolerance, then in maintenance quantities for the remainder of a 12 month period. After that time, participants were asked to ingest from 300 to 1,000 milligrams of peanut protein to test the treatment’s effectiveness; the company says 1 peanut kernel is the equivalent of 250 to 300 milligrams of peanut protein.
The primary outcome goal for the trial was the ability to ingest 600 of peanut protein in the U.S. and Canada, or 1,000 milligrams in Europe, with no more than mild reaction symptoms, after the 12-month period. About two-thirds (67%) of all children receiving AR101 were able to tolerate 600 milligrams of protein, compared to 4 percent of placebo recipients. In addition, about 3 in 4 of the AR101 recipients (77%) tolerated 300 milligrams of peanut protein, while half (50%) were able to tolerate 1,000 milligrams, compared to 8 and 2 percent respectively among placebo recipients.
Among adult participants, age 18 and older, results show higher percentages of AR101 recipients were able to tolerate 300 to 1,000 milligrams of peanut protein, but the differences were not enough to be statistically reliable.
Because the trial tested a peanut allergy treatment, nearly all — 95 to 99 percent — of participants reported some adverse effects during the trial. The research team reports the rate of adverse effects declined during the trial, with 8 or 2 percent of AR101 recipients reporting serious adverse effects, as well as 1 placebo recipient. Also, 12 percent of AR101 recipients discontinued participation during the trial, compared to 2 percent in the placebo group.
In February 2018, Science & Enterprise reported partial findings from the trial, with comparable results. Jayson Dallas, president and CEO of Aimmune, says in a statement the company expects to submit the findings to FDA as early as next month, and in Europe by the middle of 2019.
More from Science & Enterprise:
- Nasal Spray Vaccine Shown to Control Peanut Allergies
- Safety Shown for Bacterial Nasal Spray to Prevent Allergies
- Nanoparticles Built to Detect, Measure Peanut Allergy
- Air Sampling Device Finds Unreported Allergens
- Allergy Immunotherapy Firm Raises $2M in Early Funds
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