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FARE Urges FDA to Help Meet the Unmet Need for Food Allergy Therapeutics

While progress has been made over the years in the field of food allergy research, this potentially life-threatening disease affecting 15 million Americans has no cure.

On Thursday, Jan. 21, senior leadership from FARE attended a meeting of the Allergenic Products Advisory Committee at the FDA’s Center for Biologics Evaluation and Research, where committee members discussed safety data and clinical trial endpoints for licensure of food allergy immunotherapy products. The committee set aside time for presentations from members of the public.

James R. Baker, Jr., MD, FARE’s CEO and chief medical officer, and Scott Riccio, FARE’s senior vice president of education and advocacy, spoke at the meeting.

Baker, who has more than 30 years of experience as an allergist and has extensive experience in drug development from years in the biotech field, told the committee that there is “an incredible unmet need for food allergy therapeutics and probably the greatest dichotomy between need and research activity I have observed in pharmaceutical development.”

“We at FARE are strenuously working to encourage the development of therapeutics for individuals with food allergy,” Baker said.

“We know that food allergy is a complex problem and the type of cure that leaves people able to eat allergic food at will is not going to be easily achieved; the safety of individuals is therefore our primary concern.”

Importantly, FARE has invested in creating the FARE Clinical Network, consisting of 24 institutions across the country to support the highest quality of care for individuals with food allergy and provide the infrastructure necessary to do the registrational trials required for advancing the understanding of new potentially therapeutic options for food allergic individuals. Therefore FARE can speak with authority related to the issues around new therapeutics for food allergy.

Recognizing the development of food allergy therapeutics is not simple, FARE strongly supports the use of double-blinded, placebo-controlled oral food challenges as the measure of outcome for the initial therapeutics being developed for food allergy. Improved tolerance measured on food challenge is the only reliable marker that an individual has increased resistance to allergic reactions caused by accidental food ingestion, and FARE encourages the FDA to work with companies who are developing therapeutics to better define the outcomes from these challenges as they relate to potentially approvable therapeutics

“In conclusion, FARE believes that by defining a consistent and well-documented regulatory process for the approval of new therapeutics for food allergy, the FDA will help to encourage the development of these important products,” Baker told the committee. “This is a matter of great concern and a life-and-death issue to many of the 15 million people in America with food allergy.

Treatments that would help protect individuals from life-threatening reactions and are currently in clinical trials include AR101 from Aimmune Therapeutics, Inc.* and Viaskin® Peanut from DBV Technologies, both which have received Breakthrough Therapy Designation, an FDA program intended to facilitate and expedite development and review of new drugs and biologics.

The committee also heard from Riccio and his 11-year-old daughter, who has food allergies. The father-daughter combination focused on the significance of desensitization to even small amounts of allergen that can provide meaningful improvements in safety for those dealing on a daily basis with life-threatening risks from accidental exposure to the allergen. Riccio and his daughter also emphasized the importance of oral food challenges in providing real world information about the level of allergen that would cause a reaction.

Riccio testified, “It’s important that the agency recognizes how significant achieving just that lower-level threshold that would significantly increase my daughter’s safety on a daily basis.”

Riccio told committee members that protection against even a small absolute amount of peanut is a tremendously and clinically significant measure of effectiveness for his daughter, and supports his family’s perspective that an oral food challenge should be the endpoint upon which treatments could initially be approved.

Also in attendance at the committee were parents, industry representatives and other members of the research community. FDA officials and academic experts also presented to the committee. On the topic of endpoints, there was discussion on alternatives to an oral food challenge as the primary endpoint. One FDA official suggested a primary endpoint of reduction of rate or severity of reactions to accidental exposures, and raised the question about whether there are biomarkers available as an allergen specific surrogate endpoint.

FARE will continue to work to partner with the FDA, patients, industry and other key stakeholders to help advance the pace of research and new treatments for the food allergy community.

For more information on the FDA’s meeting, visit this link.

* Note from FARE:   FARE provided seed funding for Aimmune, formerly known as Allergen Research Corporation (ARC), after convening its 2011 Research Retreat. The retreat brought together leading scientists from all over the world and helped to frame key challenges with advancing oral immunotherapy through the FDA approval process, including the lack of a standardized product that could be tested in clinical trials on a broad scale. ARC sought to solve those problems, and with seed funding from FARE and other investors was able to create a standardized peanut OIT product that is being tested in Phase III clinical trials.

As an initial investor, FARE continues to hold stock in Aimmune, but we do not have any involvement with the governance or day-to-day workings of the company. This information was disclosed to the FDA.

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