Aimmune Therapeutics Announces Initiation of Phase 2 Study With Regeneron and Sanofi of AR101 With Adjunctive Dupilumab in Peanut-Allergic Patients

Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the initiation of a phase 2 study, with Regeneron and Sanofi, of AR101 with adjunctive dupilumab in peanut-allergic patients. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy, and dupilumab is Regeneron and Sanofi’s fully human monoclonal antibody that inhibits signaling of IL-4 and IL-13 cytokines, which are believed to be major drivers of type 2 inflammation. Aimmune is providing clinical supply of AR101, as well as food challenge materials, for the Regeneron-sponsored study.

"We are delighted to have Regeneron and Sanofi join us in our commitment to improve the lives of people with food allergies,” said Jayson Dallas, M.D., President and CEO of Aimmune. "Through this exciting collaboration, we can look at the potential to improve desensitization with adjunctive use of dupilumab. This collaboration is part of our ongoing effort to further and continuously characterize AR101 as the cornerstone of the platform for desensitization.”

"The incidence of food allergy continues to rise and with it the risk of life-threatening allergic reactions,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Dupilumab targets the IL-4/IL-13 signaling pathway, which is a critical driver of allergic inflammation and which we believe regulates the balance between allergic antibodies and the protective antibodies generated during desensitization. After receiving its first FDA approval, dupilumab is being explored in a wide range of diseases that we believe share a common pathway, such as asthma, nasal polyps and various allergies. Working with Aimmune is an important part of this comprehensive program and an important step to evaluate if dupilumab can help desensitization approaches designed to protect people with peanut allergies.”

Phase 2 Trial Design

The phase 2 clinical trial is designed to evaluate the efficacy and safety of dupilumab as adjunct to AR101 and is expected to enroll approximately 160 peanut-allergic patients ages 6–17 at 25 sites across the United States. All participants will receive AR101 and will be initially randomized 2:1 to receive dupilumab or placebo. Dosing with dupilumab or placebo will take place in combination with AR101 treatment through the AR101 up-dosing period.

The primary objective of the trial is to assess whether dupilumab as adjunct to AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT™) regimen, compared to placebo with AR101 in a CODIT regimen, improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a double-blind, placebo-controlled food challenge (DBPCFC) with a single-highest tolerated dose of 1,000 mg of peanut protein (equivalent to a cumulative amount of 2,044 mg of peanut protein).

There will be additional DBPCFCs after a 24-week maintenance period (for which the AR101-dupilumab patients will be re-randomized 1:1 to AR101-dupilumab or AR101-placebo) and at the end of a 12-week, treatment-free follow-up period.

About AR101

In Aimmune’s pivotal phase 3 PALISADE trial, AR101 demonstrated an encouraging tolerability and safety profile over the course of approximately one year of treatment, and approximately 80 percent of AR101 patients ages 4–17 completed the study. At the study’s conclusion, more than 60 percent of those completers tolerated the highest dose of the exit food challenge (1,000 mg / 2,043 mg cumulative).

The PALISADE trial met its primary and key secondary efficacy endpoints in the pre-specified primary analysis of the 4-17 age cohort and greatly exceeded the pre-specified 15% lower-bound of the 95% confidence interval (CI) of the difference between treatment arms at the primary endpoint. Aimmune plans to submit a U.S. regulatory filing for marketing approval of AR101 by the end of 2018.

About Dupilumab

Dupilumab (marketed under the brand name DUPIXENT^®) is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. Potential uses beyond the indication approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are investigational, and no regulatory authority has evaluated their safety and efficacy.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens 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. Aimmune plans to submit regulatory filings for marketing approval of AR101 in the United States and Europe based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 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 regarding the potential benefits of AR101, including in combination with dupilumab; Aimmune’s expectations regarding the anticipated timing of any future clinical trials, including the Phase 2 clinical trial to be sponsored by Regeneron and Sanofi; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 for peanut allergy in the United States and Europe, including the timing of these submissions; 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; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’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 June 30, 2018. 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.

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