Peanut Allergy Vaccine Candidate Nearing Finish Line

Vaccine candidate AR101 for peanut allergy patients ages 4–17 received FDA Fast Track Designation and Breakthrough Therapy Designation
small peanut being held by a man

A peanut allergy vaccine treatment may become available by the end of 2018, says biopharmaceutical company, Aimmune.

Peanut allergy is a growing health problem for which there is not an approved vaccine.

Aimmune’s goal is to relieve the burden on peanut-allergic patients and their families. Its Phase 3 clinical trial of AR101, PALISADE, focused on the reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

According to the Centers For Disease Control and Prevention (CDC), food allergies are a growing food safety and public health concern that affect an estimated 4%–6% of children in the United States.

For 80 percent of patients, peanut allergies tend to develop in childhood and persist into adulthood.

AR101, which enrolled people ages 4–49 in the United States, Canada, and eight European countries, has received U.S. Food and Drug Administration (FDA) Fast Track Designation, as well as FDA Breakthrough Therapy Designation for peanut allergy patients ages 4–17.

The peanut vaccine candidate, AR101, completed its phase 2 study in 2016, protecting:

  • 100% of patients who ate 443 mg of peanuts,
  • 90% of those who ate 1,043 mg,
  • 60% who ate 2,043 mg.

A single peanut weighs in at about 300 mg, the company says, while the average accidental exposure tends to be around half a peanut.

“We are looking at two different patient populations,” said Aimmune’s CEO Stephen Dilly, Ph.D. “There is the group of allergens you don’t really need to eat, but it’s hard to avoid them.”

Another peanut vaccine candidate has encountered approval issues.

Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy (PEPITES), is a patch that progressively empowers a person’s immune system to tolerate peanuts. The results of this phase III clinical trial did not meet the study’s primary objectives.

But, NCT02636699 did work for 35 percent of the children with peanut allergies.

According to the CDC, food allergy is a medical condition in which exposure to a food triggers a harmful immune response. The immune response called an allergic reaction, and occurs because the immune system attacks proteins in the food that are normally harmless.

The proteins that trigger the reaction are called allergens.

The symptoms of an allergic reaction to food can range from an itchy mouth, a few hives, to throat tightening, and difficulty breathing.

More than 170 foods have been reported to cause allergic reactions.

Eight major food allergens – milk, egg, peanut, tree nuts, wheat, soy, fish and crustacean shellfish – are responsible for most of the serious food allergy reactions in the United States, says the CDC.