Cow’s Milk Protein Allergy (CMPA) is often the first allergy that appears during early childhood and affects approximately 2 – 3 percent of the population in developed countries.
We have recently completed a Phase I/II trial to study the safety and efficacy of Viaskin Milk in pediatric and adolescent patients. Viaskin Milk was granted U.S. Food and Drug Administration (FDA) Fast Track Designation in September 2016.
Phase I/II Efficacy and Safety Trial – MILES
The Viaskin Milk Efficacy and Safety (MILES) trial is a multi-center, double-blind, placebo-controlled, randomized Phase I/II trial to study the safety and efficacy of Viaskin Milk conducted at 17 sites in North America. The study was divided into two consecutive parts. Part A of the MILES trial was completed with no safety concerns. Part B was designed to determine a safe and effective dose in two age groups: children ages two to 11 and adolescents ages 12 to 17 with IgE-mediated cow’s milk protein allergy, or CMPA.
Preliminary results from Part B, or Phase II, of this I/II study were announced in February, 2018. The results evaluated the efficacy and safety of three dose regimens of Viaskin Milk (150 µg, 300 µg, 500 µg) in 198 patients for the treatment of IgE-mediated cow’s milk protein allergy (CMPA). Following analyses of the data, the 300 µg dose was identified as the most effective tested dose for children (intent-to-treat (ITT), p=0.042). The Company believes these preliminary results support further advancement of the Viaskin Milk program, and intends to discuss findings with health authorities in key markets worldwide to determine the design of future studies.
Pilot Clinical Trial of Viaskin Milk with Assistance Publique Hopitaux de Paris (AP-HP)
In 2005, DBV Technologies conducted a double-blind, placebo-controlled pilot clinical trial with AP-HP in patients with cow’s milk protein allergy, or CMPA. The trial enrolled children ages three months to 15.