- Aimmune Therapeutics Inc. announced long-awaited Phase 3 data for its peanut allergy treatment AR101, revealing the drug met its goal in the PALISADE study.
- Patients ages 4 to 17 received either placebo or small amounts of AR101 sprinkled on food daily for a year. At the exit food challenge, 67.1% of AR101 patients tolerated a 600 mg dose of peanut protein, compared with only 4% on placebo.
- Shares of Aimmune jumped more than 7% in morning trading on Tuesday to trade near $40 per share. Meanwhile competitor DBV Technologies SA saw its shares fall about the same amount.
Over the last few years, investors have been closely watching Aimmune and DBV to see which company could succeed in late-stage trials and be the first to bring a peanut allergy treatment to patients.
In October, DBV disclosed that its Viaskin peanut allergy skin patch failed to meet the primary endpoint in a Phase 3 study. Viaskin only decreased sensitivity to peanuts by about 35%, compared to 13% in the placebo group. DBV said last week that it would move ahead with a regulatory filing for its skin patch this year, and analysts estimate it could hit the market by 2020.
But the success of Aimmune's compound could decease DBV's chances of garnering approval and would certainly limit its market potential. The lower-bound of the 95% confidence interval of the difference between treatment arms in the PALISADE study at the primary endpoint was 53%, greatly exceeding the pre-specified threshold of 15%.
Of the 496 evaluable patients in the study, only 10 experienced adverse safety events — one of which was on placebo. Two of the nine in the AR101 treatment group experienced severe adverse events that were deemed related to the drug, and both patients discontinued the study.
PALISADE also included 55 adult patients ages 18-49, with 21 patients in the treatment group discontinuing from the study. In an exploratory analysis of this age group, 85% of AR101 patients who completed the study tolerated at least 600 mg of peanut protein in the exit food challenge. Treatments like this are expected to have better results in children, but the analysis shows the drug might also have potential in adults with the allergy.
Aimmune said it will likely file for approval before the end of the year in the U.S. and in early 2019 in Europe.
While relatively uncommon two decades ago, the incidence of peanut allergies in children has more than doubled in the U.S., making it a lucrative market for any drugmaker that can bring an effective treatment to market. Aimmune and DBV are currently the furthest along in development, but several other companies, including Japanese pharma Astellas, have compounds in early stages.
While neither treatment from Aimmune nor DBV are cures for the allergy, they could allow peanut allergy patients to better tolerate peanut proteins and decrease the chances of having a life-threatening attack.