Aimmune Therapeutics Completes Global Enrollment Of Phase 3 PALISADE Trial Of AR101 For The Treatment Of Peanut Allergy

Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ ( Characterized Oral Desensitization Immuno Therapy) treatments for life-threatening food allergies, today announced that it has completed global enrollment of its Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy, with the total randomized to the trial expected to be approximately 540 patients. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.

Aimmune continues to expect topline data from PALISADE in the fourth quarter of 2017, followed by regulatory submissions for marketing approval of AR101 in 2018 in both the United States and Europe. The company announced completion of North American enrollment in PALISADE in September, ahead of schedule and above target enrollment.

Aimmune also announced ARTEMIS ( AR101 Trial in Europe Measuring oral Immunotherapy Success), a new dedicated European clinical trial of AR101 in peanut-allergic children and adolescents. ARTEMIS is designed to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection after a shorter treatment period in a broader group of patients (in terms of baseline reaction) than in PALISADE. The primary efficacy endpoint in this new trial will be tolerating a cumulative amount of 2,043 mg of peanut protein in an exit double-blind, placebo-controlled food challenge (DBPCFC) after approximately nine months of treatment with AR101.

"PALISADE remains the cornerstone of our AR101 program, and the completion of global enrollment is a significant milestone. Now that the $145 million investment in Aimmune by Nestlé Health Science has closed, we have additional resources to further strengthen our development strategy," said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. "As previously announced, the RAMSES study, slated to begin in the United States in early 2017, is expected to provide important experience of AR101 in a 'real-life' clinical setting, building on our observation that removal of the baseline food challenge may meaningfully improve the tolerability of the early stages of AR101 treatment. We expect to file our biologics license application (BLA) on successful completion of PALISADE and RAMSES.

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