Aimmune Therapeutics, Inc. (Nasdaq: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 Aimmune. “While the current focus of our AR101 development program is induction and maintenance of desensitization through continued treatment, the DEVIL findings give a fascinating insight into future possibilities, particularly in young children.”
Conference Call on Monday, August 22, 2016, at 4:30 p.m. Eastern Time
Aimmune will host a conference call and live audio webcast on Monday, August 22, 2016, at 4:30 p.m. Eastern Time to discuss the publication of the DEVIL study data and potential implications for development of AR101. Joining the call will be the following individuals:
Stephen Dilly, M.B.B.S., Ph.D., Chief Executive Officer of Aimmune
Daniel Adelman, M.D., Chief Medical Officer of Aimmune
Brian Vickery, M.D., Senior Medical Director at Aimmune and Clinical Assistant Professor of Pediatrics at the University of North Carolina, Chapel Hill, and Principal Investigator of the DEVIL study
Laura Hansen, Ph.D., Vice President of Investor Relations at Aimmune
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 the United States, Europe and throughout the developed world. It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United States and Europe have peanut allergy, including more than two million children. The prevalence of peanut allergy in children in the United States is estimated to have tripled between 1997 and 2008, and experts believe it has continued to rise since 2008. For people living with food allergies, certain foods can cause severe allergic reactions, including potentially life-threatening anaphylaxis. There are no approved medical therapies to cure food allergies or prevent their effects. Currently, food-allergic patients manage their condition by strict allergen avoidance and carrying epinephrine auto-injectors for use in case of accidental exposure. Thus, in addition to the unmet medical need, food allergies can impose a significant quality-of-life burden. For more information, please see www.foodallergy.org and www.niaid.nih.gov/topics/foodallergy.
About AR101 and CODIT™
Aimmune Therapeutics is developing AR101 as a potential biologic oral immunotherapy to desensitize patients with peanut allergy, protecting them from reactions to peanut allergens at a level believed to substantially exceed the amount typically encountered in an accidental exposure. AR101 maintains the complete range of natural peanut proteins, which are rigorously analyzed and combined with pharmaceutical-grade ingredients to ensure that each dose has consistent amounts of peanut protein with well-defined concentrations of peanut allergens, especially the three key allergenic proteins (Ara h1, h2 and h6). Patients ingest AR101 mixed into small amounts of palatable, age-appropriate food.
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 the United States, Canada, and the European Union. The primary endpoint is tolerating a cumulative amount of at least 1,043 mg of peanut protein after approximately six months of up-dosing and six months of maintenance therapy at a daily dose of 300 mg of AR101.
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.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized biologic product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune’s first CODIT product, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4-17 years of age. Aimmune’s pivotal Phase 3 trial of AR101, PALISADE, is now enrolling patients. For more information, please see www.aimmune.com.
- BP Vickery et al. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. Journal of Allergy and Clinical Immunology DOI: 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 Sciences and a collaboration between the UNC School of Medicine, Duke University School of Medicine and 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 the United States and foreign countries; and the company’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune's most recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended 2015 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.