The company says 800,000 Americans are allergic to egg, and that the allergy affects 6 million around the globe.
Aimmune has filed a “new investigational drug” application with the FDA in order to move forward with developing and testing the new OIT drug called AR201. As with the peanut AR101 biologic, this drug is designed to contain specific and consistent levels of egg proteins. The company expects to start a Phase 2 clinical trial with patients in 2019.
“We look forward to starting the AR201 Phase 2 clinical trial in the coming months,” said Dr. Jayson Dallas, Aimmune’s president and CEO.
Following is an excerpt of Aimmune’s press release:
BRISBANE, Calif. – Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced the submission of its investigational new drug (IND) application for AR201 for the treatment of egg allergy. The company also announced an exclusive supply agreement for egg protein with Michael Foods, Inc., the largest U.S. processor of value-added eggs. Aimmune expects to initiate a Phase 2 clinical trial of AR201 for the treatment of egg allergy in 2019.
“The prevalence, severe reactions and difficulty of avoidance associated with egg allergy create an urgent need for treatment, which we are eager to address with our AR201 program. We are extremely pleased to be working with Michael Foods on this effort,” said Jayson Dallas, M.D., President and CEO of Aimmune. “Michael Foods provides excellent technical and operational capabilities, including an extensive and reliable supply chain for our AR201 starting material. Additionally, they’re committed to our mission to improve the lives of people with food allergies. We look forward to starting the AR201 Phase 2 clinical trial in the coming months.”
Nearly 6 million people worldwide are allergic to eggs, including 800,000 in the United States and as many as 4 million across Asia, where allergy to egg is the most common food allergy. Since egg is an ingredient in so many foods, it can be especially difficult for people with egg allergy to avoid accidental consumption. Academic studies of the oral immunotherapy approach for egg allergy treatment have shown efficacy, and Aimmune’s AR201 program will study this more broadly, with a biologic drug product, in order to enable widespread availability of a potential treatment.
“Food allergies have become a major factor in the food industry and they affect the lives of so many people in our community. We’re thrilled to offer our market leadership and innovation in value-added eggs to help bring a solution to people with egg allergy,” said Mark Westphal, President of Michael Foods. “We are pleased to provide the product quality and consistency required for egg proteins to be used to develop Aimmune’s treatments ….”
Read full release here.