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Aimmune Therapeutics Enrolls First Patient in ARTEMIS (ARC010) European Phase 3 Clinical Trial of AR101 for the Treatment of Peanut Allergy

— Trial Will Augment Ongoing Phase 3 PALISADE Trial and Explore Endpoint of Tolerating at Least 1000-mg Dose of Peanut Protein to Support AR101 Regulatory Filings in Europe

BRISBANE, Calif.--(BUSINESS WIRE)--Jul. 5, 2017-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment of its first patient in the European Phase 3 ARTEMIS (ARC010) clinical trial of AR101 for treatment of peanut allergy. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.

The randomized, double-blind, placebo-controlled ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success) clinical trial of AR101 will enroll approximately 160 peanut-allergic children and adolescents ages 4-17 at multiple sites in several European countries. The ARTEMIS trial follows Aimmune’s ongoing Phase 3 PALISADE trial, taking place in eight countries in Europe, the United States, and Canada.

“We have seen great interest from peanut-allergic patients and their families in becoming participants in the Aimmune clinical trials,” said Prof. George du Toit, M.B., B.Ch., Professor of Paediatric Allergy at King's College London, Guy's and St Thomas' Trust. “Participants and their families are keen to potentially benefit from an investigational treatment in a disease area where there are currently no approved products, and are motivated to contribute to developing our understanding of peanut allergy and its treatment. We are all excited by the momentum in the field and the potential impact a new treatment could have on the burden of peanut allergy, which in many countries affects up to 2 percent of children.” Professor du Toit is an investigator for the PALISADE and ARTEMIS trials, currently underway at the Evelina Children's Hospital, Guy’s and St. Thomas’ NHS Foundation Trust in London.

Aimmune designed the ARTEMIS trial to expand the data on the level of and speed to clinically meaningful modulation of the immune response to AR101 treatment. The primary efficacy endpoint for ARTEMIS is tolerating a 1,000-mg single dose of peanut protein (the equivalent of approximately three to four peanut kernels) in a progressive, exit double-blind, placebo-controlled food challenge (DBPCFC) after approximately nine months of treatment.

“Desensitization to a threshold of at least 1,000 mg of peanut protein would protect peanut-allergic patients from severe reactions following an inadvertent bite of a peanut-containing food. Achieving high levels of protection quickly and reliably is important to patients,” said Sue Barrowcliffe, General Manager of Aimmune Europe. “In a Phase 2 study of AR101 conducted in the United States, the majority of patients met the endpoint we have set for ARTEMIS, after nine months of treatment. We hope to confirm these findings with a larger patient population in ARTEMIS, which along with PALISADE will provide the key efficacy and safety data to support our potential initial marketing authorization application for AR101 in Europe.”

The enrollment criteria for ARTEMIS allow inclusion of peanut-allergic patients who react to 300 mg or less of peanut protein in an entry DBPCFC. For more information about the ARTEMIS trial, please see: https://clinicaltrials.gov/show/NCT03201003.

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™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, 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 and is currently being evaluated in Phase 3 clinical trials. For more information, please see www.aimmune.com.

Forward-Looking Statements

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 expectations for its ARTEMIS clinical trial of AR101, including the size of the trial and the anticipated benefits from the primary efficacy endpoint; Aimmune’s expectation that its PALISADE and ARTEMIS trials will provide the primary efficacy and safety data for a potential marketing authorization application for AR101 in Europe; Aimmune’s expectations regarding the potential benefits of AR101; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. 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.

Source: Aimmune Therapeutics, Inc.

Aimmune Therapeutics, Inc.
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Laura Hansen, Ph.D., 650-396-3814
lhansen@aimmune.com
or
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Stephanie Yao, 650-351-6479
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