The add-on data showed that longer treatment with AR101 provided higher tolerance levels to peanut protein.
As Aimmune Therapeutics awaits potential regulatory approval of its peanut allergy treatment, the company released additional data that showed an extension of daily therapy with its experimental AR101 asset significantly improved tolerability to peanut allergies.
Aimmune announced results from ARC004, an open-label, rollover study of the landmark Phase III PALISADE trial that showed an extension of daily therapy with AR101 by an additional 28 weeks improved tolerability with lower numbers of adverse events compared to the PALISADE therapeutic dosing period. Initial Phase III data showed treatment with the AR101 peanut allergy therapy was effective in more than 67% of juvenile patients. At the time the trial data was released, Aimmune said the patients administered AR101 in the PALISADE trial could tolerate exposure of at least a 600-mg dose of peanut protein in the exit food challenge. Only 4% of patients on the placebo could tolerate that amount, the company said when the late-stage data was released.
The latest data though, presented at the European Academy of Allergy and Clinical Immunology Congress 2019 in Lisbon, shows that longer treatment with AR101 provides even greater protection. The study showed that 79.8% of patients who continued taking AR101, an oral biologic desensitization therapy that is sprinkled over food before eating, could tolerate doses of at least 1,000 mg of peanut protein. Nearly half, 49%, of the patients, tolerated the highest 2,000 mg dose during the exit food challenge. Patients enrolled in the study continued to see meaningful immunological changes, reinforcing the potential benefits of continued daily AR101 dosing after one year, Aimmune said.
“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 Daniel Adelman, Aimmune’s chief medical officer, said in a statement.
Adelman added that the results of the extended study should provide some peace of mind to patients with peanut allergy and their families.
Approximately 2.5% of all children in the U.S. may be allergic to peanuts. It is one of the most common food allergies. According to the American College of Allergy, Asthma and Immunology, the incidence of peanut allergies in children in the U.S. has risen about 21% since 2010.
A U.S. Food and Drug Administration advisory committee is expected to weigh in on Aimmune’s peanut allergy treatment in September. The FDA accepted the BLA for AR101 in March 2019 and previously informed Aimmune that completion of its review would be targeted by late January 2020. AR101 was granted Fast Track designation from the FDA.
Last year, in anticipation of the likely approval of AR101, Nestlé increased its stake in the company. The nearly $100 million investment gave the conglomerate a 19% ownership of Aimmune. Nestlé first pumped $145 million into the company in 2016 and then another $30 million as part of its initial public offering last year.
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