Results of New Peanut Allergy Trials Presented at EAACI Meeting
July 8th, 2015
The European Academy of Allergy and Clinical Immunology (EAACI) recently held its 2015 Annual Congress in Barcelona, Spain. FARE CEO Dr. James R. Baker, Jr. and FARE SVP of Research and Operations Mary Jane Marchisotto, attended the meeting, where new research findings about food allergies were presented. Of interest to the food allergy community, results of studies conducted by DBV Technologies and Aimmune Therapeutics were presented.
DBV Technologies presented clinical data on the company’s VIPES study, a Phase 2b trial for the treatment of peanut allergy using Viaskin® Peanut (also known as “the peanut patch”). Drs. Christophe Dupont of Necker Hospital in Paris and Hugh Sampson, director of the Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai, presented new results that continue to support the effectiveness and safety of the peanut patch.
New analyses show that 50 percent of children were able to achieve a dose of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. According to Dupont, the threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions against potential peanut traces in foods. The company remains on track to start its Phase 3 trial in peanut allergic children, the PEPITES (Peanut EPIT Efficacy and Safety study) study, in late 2015.
Also at the EAACI meeting, Aimmune Therapeutics, Inc. (previously known as Allergen Research Corporation) presented results from its Phase 2 study evaluating AR101, a peanut allergen formulation for oral immunotherapy use in the treatment of peanut allergy. The company’s clinical trial was conducted at eight U.S. sites, evaluating the effectiveness of the drug in desensitizing patients with peanut allergy. Of the 23 patients in the non-placebo group who completed the study, 100 percent tolerated exposure to 443 mg cumulative amounts of peanut protein, and 78 percent tolerated exposure to 1,043 mg cumulative amounts of peanut protein (the equivalent of approximately four peanuts). For reference, one peanut kernel contains approximately 250-300 mg of peanut protein.
Dr. A. Wesley Burks, chair of the Department of Pediatrics at the University of North Carolina-Chapel Hill, presented these data at the EAACI meeting on June 8. “These results suggest that AR101 has the potential to become the first approved oral desensitization therapy for peanut allergy, a serious and growing health problem that affects more than 5 million people in the United States and Europe, including more than two million children,” Burks said.