"The largest food allergy study done to date": AR101 powder for peanut allergy

Tom Casale on oral immunotherapy for peanut allergy by Aimunne:

The new oral immunotherapy drug (AR101) helps build tolerance to the peanut allergy in the body, which could potentially lessen the severity of symptoms during an emergency. However, AR101 is nothing more than peanut powder - nothing fancy. It was actually 12% defatted peanut flour.

The PALISADE study was published in the New England Journal of Medicine (NEJM). AR101 is one step closer to becoming the first FDA-approved treatment for protecting against accidental exposure to peanuts in children who are allergic to them.

“This is the largest food allergy study done to date,” said Dr. Thomas Casale, an allergist and immunologist with USF Health. “It is very likely this drug will be approved by the FDA, given the results we’ve had so far.”

The AR101 drug was developed by Aimmune Therapeutics and manufactured in Clearwater. Casale is a member of the company's scientific advisory board.

AR101 contains precisely measured amounts of powdered peanut protein in pull-apart capsules, which was mixed in food and taken by patients with peanut allergies. These patients were monitored by physicians over the course of more than two years, as the amount of peanut was gradually increased.

USF was one of 66 sites across the United States, Canada and Europe that tested the drug. AR101 isn’t meant to “cure” a patient of their allergy, but to provide a safety buffer in case of an accidental exposure, Casale said.

“It’s not like these people can go to a Tampa Bay Rays game and eat a bunch of peanuts,” Casale said. “But they are protected from accidental exposure.”

The only way to prevent allergic reactions to peanuts and most other food allergies currently is to avoid them.

Aimmune Therapeutics plans to file for FDA approval before the end of this year. If approved, the drug could be available for use in children ages 4 to 17 by late 2019.

Desensitization was not easy on the patients. Side effects that led to withdrawal from the trial occurred in 12% of the participants in the active-drug group and in 2% of those in the control group. This is not something to start at home. Epinephrine was used by 14% of the participants in the active-drug group as a result of reactions to treatment.



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