NEJM paper buoys Aimmune’s peanut allergy drug prospects

Peanuts in shell
A U.S. filing is scheduled for next month, with Europe following in 2019. (Pixabay/riteshman)

Results from Aimmune’s phase 3 trial of oral immunotherapy AR101 for peanut allergy have been published and bode well for the program’s planned FDA filing next month.

The PALISADE study shows that children who were classed as highly allergic to peanuts were able to tolerate a much higher exposure to peanut protein after treatment with AR101—a 12% defatted peanut flour preparation—at gradually escalating doses up to a threshold of 300 mg per day.

By the end of the 550-patient study, 67% of patients were able to tolerate eating 600 mg of peanut protein, compared to 4% of the placebo group.

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To put that in perspective for children and their parents, one peanut contains around 250 to 300 mg of peanut protein, so two-thirds of the AR101-treated patients should be able to eat three or four whole peanuts without suffering an allergic reaction, while at the start of the study their tolerance was around half a peanut.

There are around 1.6 million children and teens with peanut allergy in the U.S., and most (80%) never outgrow it. Aimmune CEO Jayson Dallas, M.D., says that the company now plans to file for approval with the FDA in December and in Europe next year. AR101 could be the first peanut allergy therapy to be approved, addressing a market that analysts at Stifel have suggested could be worth $3 billion.

The data published in the New England Journal of Medicine show that the desensitization process wasn’t always easy; almost 12% of the subjects gave up before the threshold dose was reached, and 14% had reactions that required epinephrine shots. There was no effect in a small group of 56 adults with the allergy, and as yet it is not clear whether the protection will be sustained.

Aimmune recently completed a phase 3 study (RAMSES) that it says backs up the safety and tolerability of AR101 but had a similar dropout rate. The drug is partnered with Nestlé Health Science, which just bought another $98 million worth of the biotech’s shares to take its stake to 19%. That money will be a help as Aimmune starts to prepare for filing and possible commercialization.

There’s another rival in the frame for AR101, however, as DBV Technologies’ peanut allergy patch was submitted for approval last month for peanut allergy in children aged 4 to 11 years old. That product just missed the mark in a phase 3 trial reported last year but did better in a second study, although—with the caveat that it is always hard to compare drugs based on different studies—it doesn’t seem to be as potent as AR101.

Meanwhile, another company developing a peanut allergy treatment—Camallergy—has positive phase 2 data with its oral CA002 candidate and is due to start pivotal trials next year. Also, Intromune Therapeutics met with the FDA recently to discuss trials for its own immunotherapy candidate, INT301, which delivers the peanut protein via a specialized toothpaste. It expects to start dosing the drug in 2019.

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