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news.The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Aimmune Therapeutics' lead investigational product, AR101, for oral immunotherapy of peanut-allergic children and adolescents aged four to 17 years.
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The breakthrough therapy designation follows positive results from ARC001, which is the company’s randomized, double-blind, placebo-controlled Phase II trial of AR101 for desensitization treatment of peanut allergy.
At the end of the Phase II trial, all patients who completed the active treatment regimen tolerated exposure to a cumulative amount of at least 443mg of peanut protein, and 78% of those patients tolerated exposure to a cumulative amount of 1,043mg of peanut protein.
Aimmune Therapeutics chief executive officer Stephen Dilly said: "We are very grateful for the FDA’s recognition of the large impact AR101 could have in reducing the incidence of life-threatening allergic reactions in people with peanut allergies.
"Currently, there are no approved medical therapies to treat the more than two million children and adolescents in the US and Europe with peanut allergy who are vulnerable to reactions from accidental exposures.
"We are eager to continue working closely with the FDA and to receive its guidance to help make AR101 available to patients as soon as possible."
Under the program, the FDA will work closely with the company on the subsequent development of AR101, as well as provide guidance on generating evidence needed to support approval of the drug in an efficient manner.
In September 2014, the FDA granted fast track designation for AR101, prior to Phase II clinical data.
The Phase II ARC001 trial treated 55 patients, with 29 in the active group and 26 in the placebo group.
The company intends to begin a Phase III confirmatory registration trial of AR101 for the desensitization treatment of peanut allergy in children and adults.
AR101 is part of the company’s approach to treat food allergies using its characterized oral desensitization immunotherapy (CODIT) system, which leverages extensive independent scientific research on oral immunotherapy (OIT).
The CODIT system is designed to precisely control the amount of allergen administered and follow a systematic dosing regimen that begins with very low doses of the allergen.