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Aimmune Therapeutics to Host Conference Call on Potential Positive Implications for AR101 Development From Independent Academic Study Showing Oral Immunotherapy Induces Sustained Unresponsiveness in Young Peanut-Allergic Children

Aimmune Therapeutics, Inc. (AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced that management will host a conference call to highlight the results of an independent academic clinical trial demonstrating the ability of low-dose oral immunotherapy to induce sustained unresponsiveness in peanut-allergic children under three years of age. Management will also discuss the potential positive implications of these results for the company’s ongoing development program of AR101, its biologic oral immunotherapy for desensitization of patients with peanut allergy. AR101 is currently under investigation in the Phase 3 PALISADE trial enrolling peanut-allergic patients 4-55 years of age.

The academic study called DEVIL (Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance) was recently published in the Journal of Allergy and Clinical Immunology.1 The DEVIL study showed for the first time that low-dose early oral immunotherapy leads to sustained unresponsiveness in newly diagnosed, peanut-allergic preschool children. The study was co-led by Brian P. Vickery, M.D., who is a clinical assistant professor of pediatrics at the University of North Carolina, Chapel Hill, and also a senior medical director at Aimmune, and Wesley Burks, M.D., executive dean for the UNC School of Medicine.

The DEVIL study was the first trial to investigate early oral immunotherapy in children under three years of age (9-36 months) exclusively. A total of 40 peanut-allergic participants were enrolled and randomly assigned to build up to either high-dose peanut oral immunotherapy (target maintenance dose of 3,000 mg of peanut protein daily) or low-dose peanut oral immunotherapy (300 mg daily). Participants were treated for nearly 2.5 years on average and then underwent a double-blind, placebo-controlled food challenge (DBPCFC) to 5 grams of peanut protein. Those who passed the DBPCFC then abstained from peanut exposure for four weeks prior to repeating the DBPCFC and, if successful, eating an entire serving of a peanut food openly. The results showed that approximately 80 percent of all patients achieved this outcome, called sustained unresponsiveness. Specifically, 85 percent and 71 percent of patients in the low- and high-dose groups, respectively, could consume 5 grams of peanut protein at the final food challenge, followed by the serving-size feeding, with no allergic response. Successfully treated subjects then began eating peanut regularly in the diet and are being monitored.

“The results from the DEVIL study are a big step forward in developing oral immunotherapy as a safe and effective treatment for peanut allergy,” said Dr. Vickery. “They confirm findings from other studies demonstrating that peanut OIT can create sustained unresponsiveness, and suggest that early intervention with oral immunotherapy in newly diagnosed children under three years of age can lead to a very high rate of disease modification.”

“The findings from the DEVIL study strongly support Aimmune’s goal of developing AR101 as the first rigorously characterized biologic oral immunotherapy for peanut allergy,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. “In Aimmune’s Phase 2 clinical trials, we demonstrated that AR101 therapy to 300 mg per day was able to desensitize patients with allergy to peanut and showed clinical improvements that correlated with changes in peanut-specific biomarkers, including IgE, IgG4, and Th2A cells. While our ongoing Phase 3 PALISADE trial seeks to confirm our Phase 2 results on a much larger scale, we also look forward to building on the DEVIL observations by expanding our research with AR101 into younger children.”

“It’s exciting to see evidence from a meticulously well-conducted clinical study that shows that direct engagement of the gut immune system can induce sustained unresponsiveness to a potentially life-threatening food allergen,” said Stephen Dilly, M.B.B.S., Ph.D., Chief Executive Officer of...