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.
“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.
For more information visit Aimmune.com.