Cow’s milk protein allergy (CMPA) is the first allergy that presents during early childhood and is often missed in the primary care setting. Symptoms can include gastrointestinal problems including vomiting and diarrhea, skin rash, angioedema and anaphylaxis. The only option available for CMPA management is the avoidance of cow’s milk, which can lead to issues of dietary imbalance, failure to thrive and poor quality of life.
CMPA is the most common food allergy in infants and young children, affecting 2% to 3% of the general population. In approximately 80% of CMPA cases, the allergy to cow’s milk disappears after age 16, but approximately 35% of children with severe CMPA subsequently develop other food allergies or allergic respiratory diseases.
DBV Technologies (Euronext: DBV; Nasdaq: DBVT) announced positive preliminary Phase 2 results yesterday for its Viaskin Milk product in patients suffering from immunoglobulin E (IgE) mediated CMPA. The company said that a statistically significant desensitization to milk was observed in children ages two to 11 treated with the midrange dose of Viaskin Milk 300 µg for 12 months.
Source: DBV Technologies
Three dose regimens of Viaskin Milk – 150 µg, 300 µg and 500 µg – were tested in 198 patients in two age groups: children ages two to 11 and adolescents ages 12 to 17. 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. Viaskin Milk was granted FDA Fast Track Designation in September 2016.
This is an important milestone for the millions of patients suffering from CMPA worldwide. 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.
– Dr. Stephen A. Tilles, Executive Director, ASTHMA Inc. Clinical Research Center, Physician Partner at Northwest Allergy & Asthma Center and Principal Investigator of DBV Technologies’ Phase 2 trial of Viaskin Milk.
DBV stock hasn’t recovered from the poor clinical data in October 2017 from the company’s Phase 3 Viaskin Peanut trial. While The latest data from the Viaskin Milk product, however, gives investors a reason to continue watching. The potential to help millions of patients is certainly enticing, and we’ll continue to keep a watchful eye on DBV.
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