DBV Technologies Reports Positive Data from Milk Allergy Trial
This morning the company said its Viaskin Milk product yielded successful results in a Phase II trial for patients suffering from IgE-mediated cow's milk protein allergy. The company said data shows that children on the Viaskin treatment had a statistically significant desensitization to milk after 12 months. DBV said the data shows the Viaskin Milk therapy has the potential to be the first approved treatment for this type of allergy. Children in the MILES (Milk Efficacy and Safety) study ranged in ages from two years of age to 17 years of age. The children were broken into two groups, ages two to 11 and 12 to 17.
During the MILES study, three doses of the Viaskin Milk product were tested in 198 patients in order to see which dose level was most effective. Following an analysis of data, DBV said it determined the 300 µg does, the middle dose, was the most effective. The company also tested a 150 µg dose and 500 µg dose. DBV said it intends to take the data and discuss future studies with regulatory agencies. Viaskin Milk was granted Fast Track Designation by the U.S. Food and Drug Administration in September 2016.
DBV’s Viaskin is an electrostatic patch, based on Epicutaneous Immunotherapy, which administers an allergen directly onto the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.
Stephen A Tilles, executive director of ASTHMA Inc. and the principal investigator of the MILES study, hailed the data as “an important milestone” for patients suffering from CMPA.
"We know that small amounts of cow's milk protein can cause life-threatening reactions and that this disease has a profoundly negative impact on the quality of life of patients and their caregivers. There are no other treatments in development today for this hard-to-treat disease, and it is exciting to see these encouraging efficacy and safety results with a novel potential treatment option that appears to be well-tolerated,” Tilles said in a statement.
Milk allergies are among the most common in children, affecting between 2 to 3 percent of the population. Reactions can range from mild to severe. The most severe reactions can lead to anaphylaxis, according to the Mayo Clinic. A milk allergy differs from milk intolerance. Milk or lactose intolerance typically involves different symptoms than those from a true milk allergy, which can include hives, wheezing and vomiting.
The primary efficacy endpoint of the MILES study evaluated the percentage of patients who responded to treatment as assessed by pre-specified changes compared to placebo.
The company needed some good news for its Viaskin product line. In October DBV reported its Phase III peanut allergy trial failed to show a statistically significant response against placebo.