ACAAI 2018 Perspectives - Episode 5
If the US Food and Drug Administration (FDA) were to approve Aimmune Therapeutic’s investigative AR101 drug as the first therapy for peanut allergies next year, how long until the market sees a competitor drug?
Food allergy is a difficult field to both treat and test drugs for, Simon Murray, MD, a Princeton-based internist, told MD Magazine®. The risk of anaphylaxis—or even death—in the necessary involvement of patients’ allergies in clinical trials can limit researchers’ patient pools.
That’s not to say peanut allergy care is a field solely ventured by Aimmune. Following the company’s presentation of its newest AR101 data at the American College of Allergy, Asthma & Immunology (ACAAI) annual meeting in Seattle, WA, Murray detailed the brief history of research in peanut allergy care—and the hurdles other researchers have faced.
MD Mag: Can food allergy therapies become a competitive drug market?
Well, this has been studied for 10 years, at least. A group in Cambridge, England, had developed a standardized formulation of peanut extract that came from defatted peanut flour, and they were able to, with precision, measure how much protein was in a given amount of this protein powder. So based on that work, this latest group came out and did their studies based on using defatted peanut flour.
And they were able to very precisely measure specific amounts of peanut proteins—even 0.3 mg, to 1 mg, to 10 mg, to 30 and upwards—because you have to use a standardized solution, and it has to be done in a very careful environment. In this study, one patient had to be admitted to the hospital during the process of the study, and there was about a 15% dropout rate because of adverse reactions.
You can just imagine the difficulty of enrolling patients in a study like that. Who would want to enter a study where you’re going to get the possibility of anaphylaxis? They're going to give you substances that could potentially kill you. So, the study had to be started in a hospital setting and later continued as outpatients. It had to be done with very carefully measured amounts of this protein. And this was a breakthrough—that the Cambridge group was able to find a way to document how to give carefully measured amounts.
And it has to be done pharmaceutically. You can't ask people to dilute stuff, and I just don't think it will work.