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Aimmune Therapeutics Announces Data on Terminology Used with Oral Immunotherapy Were Presented at EAACI 2018

In U.S. Survey, Allergists Want Consensus in Oral Immunotherapy Terminology —

— U.S. Allergists Preferred “Tolerated Dose” as the Most Clinically Relevant Term to Communicate Desensitization Levels to Oral Immunotherapy Patients —

BRISBANE, Calif. & MUNICH, Germany--(BUSINESS WIRE)--May 29, 2018-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that data on terminology used with oral immunotherapy were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2018 in Munich.

The data, from a recent online, Aimmune-supported survey of more than 100 practicing U.S. allergists and/or immunologists, showed considerable variability in the terminology used around oral immunotherapy. After reviewing a hypothetical patient’s progress through an oral food challenge, nearly 90 percent of the allergists surveyed selected terminology options that correctly assessed the patient’s results. However, those selections were divided among different explanations of the challenge results, revealing inconsistencies around the use of such terms as “tolerated dose,” “cumulative dose,” and “reactive dose,” along with the involvement of symptoms.

Considering the patient perspective, more than 80 percent of the allergists surveyed indicated that using the term “tolerated dose” would provide oral immunotherapy patients with the most clinically meaningful information. Additionally, 85 percent of the allergists responded that educating patients on specific terminology used in food oral immunotherapy would be useful, and 88 percent responded that achieving a stronger consensus among clinicians on the different oral immunotherapy terminology used would be extremely/very useful.

Bradley E. Chipps, M.D., presented the data in a late-breaking thematic poster session at EAACI. Dr. Chipps, of Capital Allergy & Respiratory Disease Center in Sacramento, California, is also president of the American College of Allergy, Asthma and Immunology (ACAAI).

“As immunotherapies complete late-stage clinical trials and potentially come to market, we must align on terminology that allergists can use to discuss options with patients and their families,” said Dr. Chipps. “The language from the diagnostic realm, when reactions to food challenges were used primarily to confirm an allergy, needs to evolve to support the availability of therapeutics that aim to increase the tolerated amounts of an allergen. Consistency in terminology will be important to successful implementation, patient understanding, education, and safety with this possible new standard of care.

“Oral immunotherapy patients will need information they can translate to the real world so that they can respond appropriately in instances of accidental exposure,” continued Dr. Chipps. “Knowing that the single highest level they tolerated in an office challenge amounts to a buffer above the ingestion of a peanut or more can provide significant peace of mind.”

In response to the absence of standardized terminology regarding food allergy, including clinical trial endpoints used in food allergy clinical research, the ACAAI recently posted a food allergy lexicon on its Learning Connection website to help address confusion among physicians, patients, and caregivers.

Allergists and/or immunologists who participated in the survey were board-eligible or board-certified in allergy and/or immunology, managed at least 50 patients with food allergy, spent at least 20 percent of their work week on direct patient care, and had been in practice for at least five years.

“As we talk to allergists and patient advocates, we find them to be very appreciative of efforts to help clarify the potential misunderstandings that can result from different terminology used in food allergy clinical research,” said Karin Rosén, M.D., Ph.D., Senior Vice President of Global Medical Affairs at Aimmune. “We like to use the analogy of a high jumper — it’s much more informative and meaningful to say that you’ve cleared a six-foot jump than it is to say that you’ve failed a 10-foot jump without also communicating what level you could actually pass. As we look toward the potential approval of our investigational drug product, AR101 for peanut allergy, we want to collaborate closely with allergists and patient advocates to define and communicate on those clinical trial endpoints that are most meaningful for patients in the evolving field of food allergy.”

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for potentially 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 regarding the potential benefits of AR101; Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies; and Aimmune’s expectations regarding the approvability of AR101. 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 the results of early clinical trials may not be predictive of future results; 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 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 March 31, 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.

Source: Aimmune Therapeutics, Inc.

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