ARTICLE | Clinical News

Aimmune's peanut allergy therapy meets in Phase III

February 22, 2018 10:44 PM UTC

Aimmune Therapeutics Inc. (NASDAQ:AIMT) said AR101 met the primary endpoint in the Phase III PALISADE trial to treat peanut allergy, but also reported that a greater proportion of patients in the active arm discontinued treatment compared to placebo. Aimmune plans to submit a BLA to FDA by year end and an MAA to EMA in 1H19.

On the trial's primary endpoint, a significantly greater proportion of patients ages 4-17 who received AR101 were able to tolerate a dose of at least 600 mg of peanut protein at the exit food challenge vs. placebo (67.2% vs. 4%, 95% CI: 53%, 73.3%, p<0.00001). To meet the endpoint, the trial’s prespecified success criteria required a lower bound of the 95% CI for the treatment difference of 15%. Patients in the primary analysis group tolerated no more than 30 mg of peanut protein at baseline...

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