Aimmune Therapeutics Inc. said continued use of its peanut allergy medication AR101 as part of a follow-on study improved the tolerability of peanut protein in patients.
AR101 uses trace amounts of peanut protein to slowly build up and maintain a base level of peanut tolerance in the most severely affected patients.
Peanut allergy is one of the most common food allergies, affecting more than 6 million people in the U.S. and Europe, with often severe and potentially life-threatening reactions. There is no approved treatment for peanut allergy.
In February 2018, the company disclosed that 67.2% of 496 patients ages 4 to 17 who received AR101 were able to tolerate at least 600 milligrams of peanut protein, compared to 4% for placebo, after one year of treatment in the phase 3 Palisade study.
Additionally, 50.3% of the AR101-treated patients tolerated at least 1,000 milligrams of peanut protein, versus 2.4% of the placebo patients.
The follow-on ARC004 study evaluated effects of the AR101 therapy in a subset of patients who completed the Palisade trial after extending the daily and nondaily dosing of 300 milligrams by an additional 28 weeks; 110 were assigned to the daily dosing regimen, and 104 completed a double-blind, placebo-controlled food challenge after 28 weeks.
Results from the follow-on study showed that about 79.8% of patients could tolerate doses of at least 1,000 milligrams of peanut protein, while about 49% of all the AR101-treated patients could tolerate the highest 2,000 milligrams dose in the food challenge.
AR101-treated patients also continued to see immunological changes, which reinforced potential benefits of continued daily AR101 dosing after one year, the Brisbane, Calif.-based company noted in a June 4 news release.
In addition, patients in the follow-on study saw a reduction in the side effects they experienced in the Palisade study and only 2% of patients enrolled discontinued treatment during the extended maintenance period due to adverse events.
"These findings demonstrate that AR101 treatment extended into the second year reduces adverse events, increases ability the ability to tolerate even high levels of exposure to peanut protein over time, and further modulates the immune response to peanut in most patients," said Aimmune Chief Medical Officer Daniel Adelman.
The U.S. Food and Drug Administration is expected to review the biologics license application for AR101 at a Sept. 13 meeting. Aimmune plans to submit an application seeking marketing approval from the European Medicines Agency in mid-2019.