Dive Brief:
- DBV Technologies SA on Monday announced the latest chapter in data from its Viaskin platform to treat allergies, revealing muddied results from a Phase 2 study of Viaskin Milk.
- The latter stage of a Phase 1/2 study of 198 patients with IgE-mediated cow's milk protein allergy (CMPA) tested the allergy patch in three doses as well as a placebo group. There was a high rate of response in the placebo arm of the study.
- The milk allergy patch only showed a statistically significant response in a subgroup of patients — those children aged two to 11 who were given the 300 μg dose.
Dive Insight:
Performing some analytical wrangling, DBV is proclaiming the MILES trial a success and plans to talk with regulators to move the Viaskin Milk allergy patch into Phase 3 testing.
The Viaskin technology is meant to be worn by allergy sufferers and deliver a small dose of the protein to desensitize children to the allergen over time.
The original study design tested the allergy patch in patients two to 17 years of age. But DBV decided to split those groups into children aged two to 11 and adolescents aged 12 to 17 for the final analysis of the study.
The French biotech has also decided to move ahead with only the 300 μg dose, which had a 57.9% response rate in the children group, compared to a 32.5% response rate in the placebo arm. Those children treated with the 150 μg dose had a response rate of only 34.2% and the 500 μg dose group of only 38.9%, suggesting the response is not correlated with dose levels.
Industry observers were not happy with the company's take on the data: Twitter pundits called for DBV to throw the data in the "garbage bin," while another criticized the findings as "medicore" and suggested the data was similar to trends seen with DBV's other Viaskin product.
The unimpressive results come just weeks after DBV revealed it plans to file for approval of Viaskin Peanut, its peanut allergy patch treatment, despite failing to meet the primary endpoint in a Phase 3 study.
Shares of the company were down 2.9% in morning trading to linger near $21.80.