Aimmune Therapeutics, a company focused on allergy treatments and therapies, recently announced the promising results of its third phase clinical trial of a peanut allergy oral immunotherapy. The late stage trial met its goals and was successful in desensitizing more than 67 percent of the allergic participants to 600 milligrams of peanut protein. The company hopes the therapy, called AR101, will be approved by the U.S. Food and Drug Administration (FDA) by the end of the year.
Peanut Allergy and Oral Immunotherapy
Peanut is one of the top eight food allergens in the U.S., one of the most common foods to trigger serious allergic reactions, including life-threatening anaphylaxis. As the prevalence all food allergies has risen in the last couple of decades, the number of peanut allergies has gone up by 21 percent since 2010, according to a recent study. It now affects 2.5 percent of children in the U.S.
There is no treatment for food allergies, only treatments that slow or stop allergic reactions once they begin. Many researchers trying to develop an effective therapy have focused on oral immunotherapy. This is an approach that involves exposing a child to peanut protein in increasing amounts to achieve desensitization. Aimmune’s AR101 is based on this concept.
Successful Third Phase Clinical Trial for AR101
While researchers have been working on oral immunotherapies for many years, so far success in sensitizing people has been spotty. AR101 is proving to be successful for the majority of participants in trials. In the late-phase trial, Aimmune enrolled 554 participants with peanut allergy. After receiving the six-month treatment, 67.2 percent of the patients between the ages of four and 17 tolerated a 600-milligram dose of peanut protein. This is as compared to only four percent of people in the placebo group who could tolerate the dose. More than half tolerated a 1,000-milligram dose, compared to just 2.4 percent of the placebo group.
What Aimmune has done differently with its oral immunotherapies compared to previous treatments is to use an investigational strategy the company calls CODIT (Characterized Oral Desensitization Immunotherapy). It is a standardized approach to using oral immunotherapy that includes a standard protocol, precise doses of the protein or allergen being used in the treatment, use of characterized pharmaceutical compounds and education for participants.
There is a specific and precise way in which the immunotherapy is increased for patients, so that they can become desensitized to the allergen. Once desensitization has occurred based on an allergen test, the treatment involves a daily dose for maintenance. The CODIT strategy is being tested currently for other food allergens. Aimmune does not intend for the therapy to replace food avoidance and epinephrine auto-injectors, but it is expected to prevent many instances of anaphylaxis in cases when children are accidentally exposed to an allergen.
The success of the phase three trial means that Aimmune is hopeful that AR101 can be approved and given to patients soon. It hopes that FDA approval will happen by the end of 2018 and that approval in Europe will come in 2019. For parents of children with peanut allergies this could be a major relief to be able to achieve desensitization and to have a way to further reduce the risk of anaphylaxis in addition to food avoidance.