French biopharmaceutical company DBV Technologies has announced that they’ve enrolled cow’s milk allergic subjects into a Phase I/II clinical study to evaluate the safety and efficacy of Viaskin Milk in an epicutanous patch for cow’s milk allergy treatment for children.
“Milk allergy is a life-threatening condition for which there are no approved treatments,” said Pierre-Henri Benhamou, M.D., Chairman and CEO of DBV in a release. “As part of our commitment to improve the quality of life of food allergic patients, we have continued to advance our pipeline, and the initiation of this trial marks an important milestone for our patients, their caretakers and our Company. We believe Viaskin has the potential to reshape the future of food allergies immunotherapy.”
The study is a multi-center, double-blind, placebo randomized study designed to evaluate efficacy. It will be conducted in two parts, with the first phase evaluating the safety of three escalating doses of Viaskin Milk, starting at 150 micrograms. This will take place over three weeks. Phase II will evaluate two selected doses of the product for up to twelve months of treatments. Approximately 150 subjects between the age of 2 and 17 have enrolled at selected North American sites.