Answering frequently asked questions
Many questions about food allergy causes, testing and measurement, and predictability are still unanswered. Researchers, advocates, and the participants in clinical trials are all working together to try to get those answers. Here, we’ll address some of the most common questions about our AR101 product candidate, our CODIT™ approach, and our clinical trials. Please note that AR101 has not been approved for commercial sale by the FDA or any foreign agency and is under investigation in clinical study.
The goal of our CODIT approach (and OIT in general) is desensitization, not reversal or cure or even unrestricted eating of allergic foods. Successful CODIT treatment for a person with a peanut allergy would make accidental exposure to peanuts less dangerous, with the person continuing to avoid peanuts and carry epinephrine auto-injectors.
No. We do not expect to make patients tolerant of their peanut allergen (using a strict medical definition for tolerance). Our goal is to desensitize patients to an amount of peanut somewhat larger than they might encounter in a situation of accidental exposure. Some people describe this level of desensitization as being “bite-proof.” Following treatment, people would continue to avoid peanuts and carry epinephrine auto-injectors.
Desensitization treatment with AR101, along with proper maintenance therapy, would minimize the threat posed by trace amounts of peanut protein in prepared or manufactured foods that may have shared equipment with products containing peanuts.
We believe that desensitization would be ongoing provided the person continues to faithfully comply with the maintenance therapy. Studies have shown that if a person fails to continue maintenance therapy for OIT, desensitization is lost within several weeks.
As used in our clinical trials, the treatment is designed to take place over approximately 22 weeks, with room for adjustment to accommodate variations in individual responses.
Many people with peanut allergy have an aversion to the taste and smell of peanuts. In AR101, the taste and smell are minimized and may not be detectable. We are also evaluating several masking agents to neutralize the taste and smell.
In our AR101 biologic product candidate, the peanut protein is rigorously characterized and precisely measured, allowing exact and well-understood compositions of key allergens, while maintaining all proteins, to support controlled up-dosing in a medical setting. In contrast, regular peanuts contain many natural variations.
We expect final study visits for PALISADE will be completed around year-end 2017 and that topline data will be available in the first quarter of 2018.
We are conducting our Phase 3 program for AR101 in the United States, Canada and Europe.
Our current studies are fully enrolled, but upcoming studies will be opening in the near future. Information on our clinical trials appears on clinicaltrials.gov as available and can be found by searching the site for Aimmune or AR101. Our study sites enroll patients individually.
We plan to begin studies for egg allergy in the next year, and longer-term we are exploring treatment for all major food allergies, including for people who have multiple food allergies.