BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing desensitization treatments for food allergies, today announced that it has received the European Medicines Agency (EMA) decision endorsing the company’s pediatric investigation plan, or PIP, for AR101 for the treatment of peanut allergy. The decision follows the EMA Paediatric Committee (PDCO) positive opinion on the PIP on August 14, 2015.
In Europe, an approved PIP is a required component of the EMA regulatory approval process. A marketing authorisation application (MAA) can be accepted only if the sponsor has an approved PIP and has completed the relevant studies outlined in that plan.
“This positive opinion on our PIP puts us another step closer to having a treatment to desensitize patients with peanut allergy and keep them safe from dangerous reactions upon accidental exposure,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D.. “With more than a million children in Europe living with peanut allergy, we are dedicated to bringing them a treatment that can give them and their families a significant level of protection and peace of mind in their daily lives.”
In June, Aimmune announced that the results of its ARC001 Phase 2 trial of AR101 for the treatment of peanut allergy demonstrated efficacy and overall safety in peanut-allergic patients (ages 4-21). In that study, 100 percent of the 23 active-arm patients who completed the study met the primary endpoint of tolerating exposure to 443 mg cumulative amounts of peanut protein, and 78 percent met an additional endpoint of tolerating exposure to 1,043 mg cumulative amounts of peanut protein.
The approved PIP includes Aimmune’s planned Phase 3 trial of AR101 for the treatment of peanut allergy, expected to commence in early 2016. This randomized, double-blind, placebo-controlled trial will enroll approximately 500 peanut-allergic children, adolescents and adults (ages 4-55) in the United States and Europe. The PIP also includes an additional randomized, double-blind, placebo-controlled study designed to potentially allow expansion of the age range for AR101 treatment down to one-year-old children. This additional study does not need to be completed prior to potential approval of AR101.
About AR101 and CODIT™
Aimmune Therapeutics is developing AR101 as a potential desensitization therapy for patients with peanut allergy to provide them with protection from peanut allergens at a level believed to substantially exceed the amount typically encountered in an accidental exposure. AR101 is a complex mixture of naturally occurring proteins and pharmaceutical-grade inactive ingredients designed to enable the convenient dosing of consistent amounts of peanut protein with well-defined concentrations of peanut allergens. Patients ingest AR101 mixed into small amounts of palatable, age-appropriate foods.
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 desensitization to a clinically meaningful level, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain the desensitization.
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 increased at a constant annual growth rate of approximately 10 percent 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 Aimmune Therapeutics
Aimmune Therapeutics, Inc., founded in 2011 as Allergen Research Corporation (ARC), is a clinical-stage biopharmaceutical company developing treatments for peanut allergy and other food allergies. Aimmune’s characterized oral desensitization immunotherapy (CODIT™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune recently completed a Phase 2 study of its lead product, AR101, a complex mixture of naturally occurring proteins and pharmaceutical-grade ingredients for the treatment of peanut allergy, one of the most common food allergies. For more information, please see www.aimmune.com.
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: the timing and size of Aimmune’s planned Phase 3 trial; Aimmune’s expectations regarding the potential benefits of AR101; and Aimmune’s expectations regarding the potential applications of the CODIT™ system. Risks 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; reliance on third parties for the manufacture of the company’s product candidates; 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 (SEC), including the prospectus relating to the initial public offering dated August 5, 2015, and the Quarterly Report on Form 10-Q for the second quarter of 2015 dated August 31, 2015. 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.
This press release concerns a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.