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Aimmune Therapeutics Enrolls First Patient in RAMSES (ARC007), a Phase 3 Clinical Trial of AR101 for the Treatment of Peanut Allergy

— “Real-World” Trial Will Augment Ongoing Phase 3 PALISADE Trial to Support Regulatory Filings and Market Understanding —

BRISBANE, Calif.--(BUSINESS WIRE)--May 11, 2017-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), today announced the enrollment of its first patient in the Phase 3 RAMSES (ARC007) 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 Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Age 4-17 Years, or RAMSES (ARC007), trial is designed to gain experience with AR101 in a real-world setting, without the use of a double-blind, placebo-controlled food challenge (DBPCFC) to confirm peanut allergy. It will assess the safety and tolerability of AR101 versus placebo. The trial follows the same up-dosing and maintenance protocol as Aimmune’s ongoing Phase 3 PALISADE trial, taking place in the United States, Canada, and eight countries in Europe.

“The peanut-allergic patients in my practice have been highly motivated to participate in Aimmune’s clinical trials. They’re looking for access to a potential treatment, since peanut allergy patients are at risk for life-threatening anaphylaxis and have to take extra caution with eating. My patients have been happy to have the opportunity to participate in these clinical trials and help with the effort which may lead to an approved product to treat their problem,” said Stanley M. Fineman, M.D., Atlanta Asthma & Allergy. “Not requiring the diagnostic food challenge requirement is more consistent with the way we practice, where the diagnosis of peanut allergy is typically made based on a strong clinical history and corroborating positive skin prick tests and/or elevated blood levels of peanut antibodies.”

RAMSES (ARC007) is a randomized, double-blind, placebo-controlled trial enrolling approximately 440 peanut-allergic patients ages 4–17 at multiple sites in the United States and Canada. Patient selection is based on stringent entry criteria, including a well-documented medical history of IgE-mediated reactions to peanut (including anaphylaxis), skin reactivity, and analyses of peanut-specific allergic antibodies.

The trial will monitor treatment-emergent adverse events during a six-month up-dosing period, and then, after unblinding, follow patients for at least six months on the maintenance dose of 300 mg of AR101 per day. Aimmune anticipates that the absence of an entry food challenge may improve the tolerability profile of AR101 in early stages of dosing by removing exposure to high levels of peanut allergen that may otherwise prime the immune system prior to treatment.

“We’re conducting our RAMSES trial not only to support regulatory filings and real-world market understanding, but also to test whether removing the entry food challenge can lead to improved tolerability of AR101 during early up-dosing. Recent data from our collaborator Dr. Erik Wambre and his colleagues at the Benaroya Research Institute on PALISADE patient samples support the idea that the food challenge may activate the immune system and thus increase the risk of additional allergic reactions in the early up-dosing period that follows,” said Aimmune CMO, Daniel Adelman, M.D. “Also, while some studies1,2 have shown that food allergy patients and caregivers report improvements in quality of life following food challenges, regardless of outcome, the process can be emotionally tough. We’ve been hearing a lot of enthusiasm from our PALISADE sites about starting RAMSES, and many of them have waitlisted patients who are eager to participate in the trial.”

For more information about the RAMSES (ARC007) trial, please see:

https://clinicaltrials.gov/ct2/show/NCT03126227

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.

References

1. Franxman TJ, Howe L, Teich E, Greenhawt MJ. Oral food challenge and food allergy quality of life in caregivers of children with food allergy. Journal of Allergy and Clinical Immunology: In Practice 2015; 3:50.

2. van der Velde, J.L., Flokstra-de Blok, B.M., de Groot, H., Oude-Elberink, J.N., Kerkhof, M., Duiverman, E.J. et al, Food allergy-related quality of life after double-blind, placebo-controlled food challenges in adults, adolescents, and children. Journal of Allergy and Clinical Immunology 2012; 130:1136–1143.e2.

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 RAMSES clinical trial of AR101, including the expectation that the absence of a food challenge in the trial may improve the tolerability of AR101; 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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