Aimmune Therapeutics announced positive results from their pivotal Phase 3 PALISADE trial evaluating the orally-administered biologic immunotherapy AR101 as a potential treatment for peanut allergy. 

The Phase 3 PALISADE trial enrolled 499 peanut-allergic patients ages 4–17 years old.  Participants underwent a dose escalation period of approximately 22 weeks to reach a maintenance dose of 300mg per day of AR101 or placebo, then continued with daily maintenance for 6 months. After the maintenance period, they underwent an exit double-blind, placebo-controlled food challenge (DBPCFC) which tested doses of 3mg, 10mg, 30mg, 100mg, 300mg, 600mg and 1000mg of peanut protein, given 20–30 minutes apart. 

The results showed that 76.6%, 67.2%, and 50.3% of the AR101-treated patients (n=372) were able to tolerate 300mg, 600mg, and 1000mg doses of peanut protein, compared with 8.1%, 4.0% and 2.4% of the placebo patients (n=124) (all P<0.00001). Among patients who completed treatment, 96.3%, 84.5%, and 63.2% of the AR101-treated patients (n=296) were able to tolerate 300mg, 600mg, and 100mg doses of peanut protein, compared with 8.6%, 4.3%, and 2.6% of placebo patients (n=116) (all P<0.00001). 

With regard to adverse events, 12.4% of AR101-treated patients discontinued treatment due to treatment-related side effects; these included gastrointestinal adverse events (6.7%) and systemic allergic hypersensitivity reactions (2.7%).

Aimmune expects to submit a Biologics License Application (BLA) for AR101 with the FDA by the end of 2018. 

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“We’re very encouraged that the data from PALISADE are helping to define the magnitude of the potential treatment effect in very sensitive peanut-allergic patients,” said Daniel C. Adelman, MD, CMO of Aimmune.

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