Development Program:
Viaskin™ Milk
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 completed a Phase 1/2 trial to study the safety and efficacy of Viaskin Milk in pediatric and adolescent patients.
Clinical Trials (IgE-mediated Cow’s Milk Allergy)
MILES (Viaskin Milk Efficacy and Safety)
MILES is a multi-center, double-blind, placebo-controlled, randomized Phase 1/2 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 2 to 11 and adolescents ages 12 to 17 with IgE-mediated cow’s milk protein allergy, or CMPA.
External Collaborations
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 to evaluate the safety of Viaskin Milk in children. This pilot trial enrolled 21 infants (starting at three months) and children (up to age 15) with cow’s milk allergy.
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Clinical Trials (Non-IgE-mediated Cow’s Milk Allergy Diagnosis)
APTITUDE
APTITUDE is a non-randomized, triple-blinded, placebo-controlled Phase 2 trial in 27 sites in North America and Europe. This two-arm study is designed to assess the sensitivity, specificity and positive and negative predictive value of DBV1605 as a ready-to-use atopy patch test for the diagnosis of non-IgE mediated cow’s milk allergy in children ages 1 month to 5 years. This is an ongoing trial, with estimated enrollment of 230 subjects.
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* Viaskin Milk is an investigational product and has not been approved for any use in any country.