DBV reports Phase I/II data for milk protein allergy therapy

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) reported preliminary data from the Phase II portion of the Phase I/II MILES trial to treat IgE-mediated cow’s milk protein allergy showing that the once-daily 300 µg dose of Viaskin Milk patch was identified as "most effective" tested dose for children.

The trial enrolled 198 patients ages 2-17 to receive placebo or once-daily 150, 300 or 500 µg Viaskin Milk. In children ages 2-11, a significantly greater proportion of patients who received once-daily 300 µg Viaskin Milk achieved a response at 12 months vs. placebo (57.9% vs. 32.5%, p=0.042). A response was defined as achieving a ≥10-fold increase in cumulative reactive dose (CRD) of cow’s milk protein and ≥144 mg of cow’s milk protein, or a CRD of cow’s milk protein of ≥1,444 mg. DBV said it will prioritize children ages 2-11 for future studies of the product. Viaskin Milk was well tolerated with no treatment-related serious adverse events reported...