Aimmune AR101 Drug Protecting Children Against Peanut Allergies

An experimental drug derived from peanuts protected some children and adolescents with life-threatening peanut allergies, according to a study.

By Peter Loftus – WSJ

An experimental drug derived from peanuts protected some children and adolescents with life-threatening peanut allergies, according to a study, allowing the subjects to eat small amounts of peanuts without suffering a serious reaction.

The drug, from a small California company, Aimmune Therapeutics, didn’t work for everyone, has some side effects and hasn’t been approved by regulators for sale. Yet the findings from the late-stage trial promise a potential new solution for peanut allergies, a growing concern.

Peanut allergies have emerged as a life-threatening peril for many parents, forcing them to pore over ingredients for any signs of peanuts and to equip their children—and their children’s schools—with devices to help with sudden and unexpected allergic reactions.

The incidence of peanut allergies in children has risen 21%in the U.S. since 2010, according to the American College of Allergy, Asthma and Immunology, a medical society. Nearly 2.5% of children in the U.S. may have a peanut allergy. Yet there isn’t an approved medicine that can prevent the allergy attacks. Instead, doctors have for years advised that children avoid peanuts altogether, not an easy task. And those with the allergies carry emergency epinephrine shots in case of an accidental exposure.

Research in recent years has raised hopes for a preventive treatment. The research has shown gradually introducing small amounts of peanut containing foods to children could prevent or limit the severity of allergic reactions.

The approach is known as oral immunotherapy. The experimental drug developed by Aimmune, of Brisbane, Calif., builds on that concept. The drug, called AR101, is made from peanut flour and given as a powder mixed in with other foods.

The Aimmune-funded study enrolled nearly 500 children ages 4 to 17 years old with peanut allergies, in the U.S. and nine other countries. Att he start, the patients had allergic reactions to no more than 100 milligrams of peanut protein, equivalent to one-third of a peanut kernel.

A majority of the participants were given AR101 in escalating daily doses and then a maintenance dose for several months, while the rest took a placebo. At the end of the dosing period, the children were given a “food challenge” that included eating peanut protein.

The 12-month study found that 67.2% of the children taking AR101 were able to ingest a single dose of at least 600 milligrams of peanut protein—the equivalent of about two whole peanut kernels—while experiencing no more than mild symptoms, compared with only 4% of the children in the placebo group.

The level of protection the drug afforded to patients “makes a huge difference in their lives, not having to fear an accidental peanut ingestion causing a severe allergic reaction,” said A. Wesley Burks, a co-author of the study. Dr. Burks is executive dean for the University of North Carolina School of Medicine and serves on a the study. Dr. Burks is executive dean for the University of North Carolina School of Medicine and serves on a scientific advisory board for Aimmune.

Aimmune had released the study’s top-level findings in February.The full data were presented Sunday at a conference in Seattle held by the American College of Allergy, Asthma & Immunology, and published online by the New England Journal of Medicine.

The drug comes with side effects. About 4.3% of those taking AR101 had severe reactions, versus less than 1% among those getting a placebo.Patients taking the drug also had higher rates of gastrointestinal and respiratory side effects. Some 11.6% of those who started taking the drug withdrew from the trial because of side effects.

The trial also enrolled a smaller number of adults, but the drug didn’t provide a significant benefit versus placebo in these participants.

Michael R. Perkin, a pediatric allergy consultant at St. George’s Hospital in London, wrote in an editorial in the New England Journal of Medicine that AR101 showed potential to start children on immunotherapy. But he said the study didn’t show whether the drug induces tolerance of peanuts that could be maintained for a long period in the absence of continuing peanut consumption. Aimmune plans to file for U.S. Food and Drug Administration approval of AR101 in December, a spokeswoman said. She said she didn’t have information about the potential cost of the drug if it is cleared for sale.

Source: WSJ https://www.wsj.com/articles/experimental-drug-shows-promise-protecting-against-peanut-allergies-1542595450