FDA and the European Medicines Agency recently gave the biotech company DBV Technologies a green light to launch Phase III clinical trials of its Viaskin Peanut allergy treatment patch. The trials, which will be in the fourth quarter of 2015 will focus on children 4 to 11 years old, the company announced June 23.
The company also hopes to test the patch, which allows medicine to be absorbed through intact skin and avoid blood transfer, on younger and older patients as well – a proposal it hopes to discuss with FDA in the back half of 2015.
Success will be measured by how many children who have allergic reaction to 10 mg or less of peanut protein can tolerate at least 300 mg of peanut protein after 12 months of treatment. In addition, the company hopes children who can tolerate 10 mg or more of peanut protein at baseline will be able to tolerate up to 1,000 mg after a year of treatment, according to the firm, which is developing similar technology for milk allergies, too.
The research also will seek to establish how much or little peanut protein it takes to trigger a reaction after a year verses a placebo, it added.
Creating hypoallergenic peanuts
On the food side, scientists at North Carolina A & T University discovered a way to remover 98% of the allergens from peanuts without affecting the flavor, the U.S. Department of Agriculture touts in its 2014 Annual Report on Technology Transfer published June 24.
USDA explains in the report that “researchers found by soaking roasted peanuts that have been shelled and skinned in a solution containing food-grade enzymes, they can virtually reduce or eliminate key allergens.”
Specifically, the process reduces the allergen Ara h1 to undetectable levels, and Ara h2 by up to 98%, according to the school.
The non-GMO peanuts can be eaten whole, in pieces or ground into a powder, and are ready for product development, Xemerge, which signed an exclusive licensing agreement for the patented process of making hypoallergenic peanuts, announced last October.
“Because of this work, hypoallergenic peanut products are expected to his store shelves soon,” USDA said in the report.