New options on the horizon for children with cow's milk allergy

There are currently no approved treatments for children with milk allergies except avoidance, but that may be going to change. The clinical-stage specialty biopharmaceutical company DBV Technologies has begun enrolling cow’s milk-allergic subjects in a Phase I/II clinical study to evaluate the safety and efficacy of Viaskin Milk, an epicutaneous patch for the treatment of children with IgE-mediated cow’s milk allergy (CMA).

CMA is the first allergy to appear during early childhood and the most common food allergy in infants and young children, affecting 2 to 3% of the general population. CMA is often missed in the primary care setting and can be a significant cause of infant distress when left undiagnosed. Symptoms can include gastrointestinal problems including vomiting and diarrhoea, skin rash, angioedema or rapid swelling of the skin, and anaphylaxis. The only option available for CMA management is the avoidance of cow’s milk, which can lead to issues of dietary imbalance, failure to thrive and poor quality of life.

The Viaskin MILk Efficacy and Safety Phase I/II study, or MILES study, is a multicentre, double-blind, placebo-controlled, randomised study designed to evaluate the safety and efficacy of Viaskin Milk used to treat subjects on a daily basis by Epicutaneous Immunotherapy (EPIT). Eligible subjects are those with elevated cow’s milk-specific Immunoglobulin E levels and who show clear objective signs or symptoms to an eliciting dose of cow’s milk proteins ≤300 mg (approximately 9.4 mL of cow’s milk).

DBV Technologies has developed a worldwide-patented technology for administering an allergen to intact skin while avoiding transfer to the blood, thus considerably lowering the risk of a systemic, allergic reaction in the event of accidental exposure. DBV Technologies is focusing on food allergies, including milk and peanut, for which there are currently no effective treatments.

The MILES study is composed of two parts. Part A, or Phase I, will evaluate the safety of three escalating doses of Viaskin Milk (150, 300 and 500 μg cow’s milk protein) versus placebo over three weeks. Part B, or Phase II, will evaluate the efficacy and safety of up to 12 months of EPIT with two selected doses of Viaskin Milk from Part A. Approximately 150 subjects (18 subjects in Part A and 132 subjects in Part B) from 2 to 17 years of age will be randomised in the study, at selected North American sites, specialised in the management of food allergic subjects.

The primary efficacy endpoint is the percentage of treatment responders after 12 months of EPIT. Responders are subjects who meet one of the following criteria: a ≥10-fold increase in the cumulative reactive dose (CRD) of cow’s milk proteins at the Month 12 food challenge as compared to the baseline value and reaching at least 144 mg of cow’s milk proteins (approximately 4.5 mL of milk); or a CRD of cow’s milk proteins ≥1444 mg (approximately 45 mL of milk) at the Month 12 food challenge