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 Epicutaneous Immunotherapy in Cow’s Milk Allergy with Assistance Publique Hopitaux de Paris (AP-HP)
In 2006 a double-blind, placebo-controlled pilot clinical trial was initiated with AP-HP. This pilot trial recruited infants (starting at three months) to children (up to ages 15) with cow’s milk allergy, using an epicutaneous delivery system containing cow’s milk powder. The results of this pilot showed a good safety profile and a clear trend toward clinical efficacy.