Phase III Study Results for Peanut Allergy Therapy Are a Mixed Bag

Efficacy is promising, but questions over safety and price remain.

Aimmune Therapeutics is developing a therapy for patients suffering from peanut allergies that could allow them to tolerate limited exposure to nuts. Without the treatment, they could suffer a several and potentially fatal response. 

The company just completed a phase 3 study of AR101, which involves the use of carefully controlled 12% defatted peanut flour. In the study, two-thirds of 4- to 17-year-old allergic patients were eventually able to tolerate a dose of up to 4 peanuts without having the severe reactions they normally would, compared to just 4% of the placebo group. 

That’s the good news. The troubling aspects of the study have to do with the safety of the treatment. Slightly more than 11% of the patients on AR101 dropped out of the study due to side effects, compared to 2.4% in the placebo arm. In addition, 14.0% of the participants in the active-drug group needed to use epinephrine to suppress reactions to treatment. In addition, there are questions about the impact the ongoing consumption of an allergen that causes the body to produce IgE antibodies may have.

The other issue is the proposed price of the therapy. The defatted peanut flour is a natural byproduct that costs virtually nothing to make, but the company is expected to put a high price on it if it receives approval from the US Food and Drug Administration (FDA). Aimmune is expected to submit a new drug application with FDA before the end of the year and to the European Medicines Agency in 2019.

Even so, the results of the study have attracted attention for the company. Nestlé Health Science increased its investment in Aimmune Therapeutics by $98 million. It has now plowed $276 million into the company and owns a 19% share.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.