DBV Technologies has completed the enrollment for Part B, or Phase II, of the Phase I/II study of Viaskin Milk for the treatment of patients with IgE-mediated cow`s milk protein allergy (CMPA).
The MILES trial is evaluating the efficacy and safety of Viaskin Milk in desensitizing children two to 17 years of age suffering from CMPA. The Viaskin Milk patch is based on DBV`s epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin. The blinded part of the MILES study is expected to complete in the second half of 2017.
No safety concerns were observed during Part A of the MILES Study (Phase I), for which study results were presented at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles, CA, on March 6, by Karine Rutault, Director, Clinical Projects, DBV Technologies. In Phase II, or Part B of the MILES study, a total of 283 patients were screened. The Company expects approximately 176 children with IgE-mediated CMPA will be randomized 1:1:1:1 to receive one of the three doses of Viaskin Milk (150 µg, 300 µg, 500 µg) or placebo for 12 months.
“This is an important milestone for the treatment of pediatric CMPA, a disease affecting millions of patients worldwide, who are often times at risk of experiencing life-threatening reactions to undetectable traces of cow`s milk protein in their everyday lives,” said Dr. Anna Nowak-Wegrzyn, Associate Professor, Pediatrics, Allergy and Immunology at Jaffe Food Allergy Institute, Mount Sinai School of Medicine in New York and the Principal Investigator of the MILES trial at Mount Sinai Medical Center.
“CMPA is one of the most common food allergies in children today and we look forward to seeing the results from this groundbreaking trial. Viaskin Milk, if proven safe and effective in clinical trials, could be the first product candidate to offer a potential treatment option for these patients, if approved.”