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
─ Academic Study Recently Published in the Journal of Allergy and Clinical Immunology Provides Support for Aimmune’s Planned Pediatric Trial of AR101 ─
─ Conference Call on
The academic study called DEVIL (Determining the Efficacy
and Value of Immunotherapy on the Likelihood of
Peanut Tolerance) was recently published in the
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
“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
Conference Call on
Aimmune will host a conference call and live audio webcast on
The conference call will be accessible via the company’s website at www.aimmune.com on the Events page under Investor Relations. Please connect to the company’s website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be required to listen to the webcast and to download the slide presentation for the conference call. Alternatively, participants may dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and refer to conference ID 67384206. An archived copy of the webcast will be available on the company’s website for at least 30 days after the conference call.
About Food Allergies
Food allergies are a significant and growing health problem in
About AR101 and CODIT™
AR101 is part of Aimmune’s approach to treating food allergies using its Characterized Oral Desensitization ImmunoTherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune’s CODIT system is designed to precisely control the amounts of the allergens administered in a systematic dosing regimen, beginning with very low doses of the allergens. Once a patient attains a clinically meaningful level of desensitization, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain the desensitization.
About Aimmune’s Phase 3 PALISADE Trial
PALISADE is a randomized 3:1, double-blind, placebo-controlled pivotal
Phase 3 trial expected to enroll approximately 500 peanut-allergic
patients 4-55 years of age at more than 65 clinical sites in
PALISADE is based on Aimmune’s Phase 2 program for AR101, which enrolled 55 peanut-allergic patients 4-21 years of age. In that program, after nine months of treatment with AR101, the percentage of patients who tolerated 443 mg and 1,043 mg of peanut protein was 100 percent and 90 percent, respectively (corresponding to 73 percent and 65 percent, respectively, on an intent-to-treat basis).
With the CODIT regimen, approximately 90 percent of the treatment-related adverse events in Phase 2 have been mild, predominantly allergic symptoms, consistent with stimulation of the immune system. There have been no treatment-related severe adverse events. Early discontinuation from therapy for related adverse events was observed in approximately 18 percent of patients; all had peanut-specific immunoglobulin E (IgE) levels in excess of 100 kU/L prior to treatment. Aimmune is actively investigating biomarkers, including peanut-specific IgE, as potential predictors of response to AR101 therapy.
For more information about PALISADE, please see https://clinicaltrials.gov/ct2/show/NCT02635776.
BP Vickeryet al. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. Journal of Allergy and Clinical ImmunologyDOI: 10.1016/j.jaci.2016.05.027 (2016). The trial was supported by the National Institute of Allergy and Infectious Diseases, the National Center for Advancing Translational Sciencesand a collaboration between the UNC School of Medicine, Duke University School of Medicineand Johns Hopkins School of Medicine.
Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: Aimmune’s belief that the results of the DEVIL
study have potential positive implications for the development of AR101
and that, based on the results of the DEVIL study, early intervention
with oral immunotherapy in children under three years of age can lead to
a high rate of disease modification in peanut allergy; Aimmune’s
expectations for its Phase 3 PALISADE trial of AR101, including its
expected size; Aimmune’s expectations regarding the potential benefits
of AR101; Aimmune’s expectations of a predictive biomarker test for
treatment response of AR101; Aimmune’s plans to investigate AR101 in
pediatric patients; and Aimmune’s expectations regarding potential
applications of the CODIT™ system. Risks and uncertainties that
contribute to the uncertain nature of the forward-looking statements
include: the expectation that Aimmune will need additional funds to
finance its operations; the company’s ability to initiate and/or
complete clinical trials; the unpredictability of the regulatory
process; the possibility that Aimmune’s clinical trials will not be
successful; Aimmune’s dependence on the success of AR101; the company’s
reliance on third parties for the manufacture of the company’s product
candidates; possible regulatory developments in