• An experimental peanut allergy drug from Aimmune Therapeutics has met the primary endpoint of a Phase 3 European study, according to topline data released by the company on Monday.
• The ARTEMIS study enrolled 175 children allergic to peanuts. After roughly nine months of treatment with Aimmune’s AR101, the median dose of peanut protein the children could tolerate increased 100-fold. Compared with placebo, a significantly higher proportion of treated participants could tolerate 1,000 mg of peanut protein, equivalent to around three or four whole peanuts.
• The results support those of another late-stage trial, PALISADE, which also read out positive. Data from ARTEMIS, PALISADE and two more studies will be used as the basis for a marketing authorization application that Aimmune intends to submit to the European Medicines Agency in mid-2019.

With positive data in hand from multiple late-stage trials, Aimmune could become the first drug company with a drug for peanut allergy approved in both the U.S. and Europe.

Peanut allergy affects up to 2% of children. Its symptoms range from hives, eczema and asthma to, in very severe cases, cardiac arrest or death.

Patients may soon have another treatment option with AR101, a kind of peanut flour that’s administered as an oral biologic.

The Food and Drug Administration recently accepted the Biologics License Application for AR101, though the filing did get caught up in the complications of the 35-day U.S. government shutdown. The agency assigned AR101 the standard 12-month review for allergenic products, meaning a U.S. approval decision isn’t expected until January 2019 — somewhat later than Aimmune had hoped.

The company expects to file AR101 with European regulators in a few months, supported in part by results from ARTEMIS.

Regarding the topline data released Monday, Aimmune CEO Jayson Dallas said that AR101’s “level of protection provides ample buffer beyond a typical bite of a peanut-containing food in the real world.”

“If approved, AR101 could significantly reduce their risk of severe, potentially life-threatening reactions to peanut exposures and provide peace of mind to them and their families,” Dallas added.

Christopher Raymond, an analyst at Piper Jaffray, argues that the new topline results de-risk AR101’s efficacy and safety profile, particularly as there have been no cases of anaphylaxis or eosinophilic esophagitis. Raymond expects a U.S. launch of the drug in 2020 and a European launch in 2021. He models stateside AR101 revenues of $69 million, $237 million and $458 million for the fiscal years spanning from 2020 to 2022, respectively.

Credit Suisse also anticipates a positive commercial launch for AR101, provided Aimmune establishes the right marketing team.

“We see significant interest in the product from physicians and patients/parents, a side effect profile that appears manageable and a commercial opportunity that can be addressed through a targeted sales force,” Vamil Divan, an analyst at the investment bank, wrote in a March 25 note.