Supplement to offer structured introduction of potential food allergens into kids' diets
The company, which is headed by CEO and co-founder Ashley Dombkowski, PhD, has a product platform whose aim is to head food allergies off at the pass with the measured delivery of tiny amounts of allergenic proteins to infants. The approach is the brain child of Dombkowski's co-founder Dr. Kari Nadeau, a pediatrician, mother of five, and the director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford University.
The approach has been seen as having enough promise to have attracted a recent $35 million capital infusion. The private funding is structured as a Series B financing round led by Gurnet Point Capital. In conjunction with the financing, two new directors will join the Board: Christopher Viehbacher, the managing partner of Gurnet Point Capital and former CEO of Sanofi S.A., along with Greg Horn, the CEO of Specialty Nutrition Group, Inc. and former CEO of both GNC Holdings, Inc. and Garden of Life.
Problem creates opportunity
Dombkowski spoke with NutraIngredients-USA about the company’s business plan. She said the company is still very early in the product development cycle, so many details are still hazy and/or proprietary, but she did say the plan is to bring a product to market positioned as a dietary supplement that parents could use to help prevent the development of crippling food allergies in their children. Dombkowski said the allergy problem has many roots, and a supplement-like product could be one way to strike at some of these targets without purporting to be a one-size-fits-all solution.
“Food allergies are really a multifactorial disease,” Dombkowski said. “What has been interesting to observers is that the increase in food allergies has accelerated so much in the recent period. That appears to be caused by a lot of things.”
According to a 2013 study by the Centers for Disease Control and Prevention (CDC) the incidence of food allergies in children in the United States increased 50% in the period from 1997 to 2011. By some estimates, 15 million Americans struggle with food allergies, and 1 in 13 children are affected. And the annual health care cost for these conditions is around $25 billion. The problem is not restricted to the U.S.; the same assessment estimates that 17 million people in Europe deal with food allergies, too.
Researchers have struggled to identify root causes, other than to have concluded, as Dombkowski mentioned, that there are many contributing factors. The best way for parents to deal with these conditions was at first thought to be to restrict exposure to allergenic foods as much as possible. That thinking has now changed, and health authorities now recommend introducing small amounts of potentially allergenic foods early in a child’s life as a way to train their developing immune systems to deal with these substances in a nonreactive way.
Early introduction now the norm
“At first it was thought that maybe one of the ways we address this is to really restrict the diet. But now there is all this information from long term birth cohorts, and it turned out early introduction was associated with lower incidence of food allergies. It wasn’t clear whether that was correlative or causative,” Dombkowski said.
The recommendations call for very small amounts of potentially allergenic proteins be introduced as children transition to solid food. Dombkowski said the plan is for her company’s eventual product to include all of those in the proper amounts in a single dose to get the guesswork out of the equation for parents, and to include things like shrimp that some kids might not like eating in the first place.
“The recommendations now calls for healthy babies to begin eating foods out of the allergenic categories at four to six months of age,” she said. “Peanuts account for 25% of food allergies but there are other things beyond peanuts. We have developed a dietary supplement base that includes vitamin D that will cover 16 different categories of foods. We will include small amounts of real foods. To get all of those things into the diet on a daily basis is complicated and expensive.”