DBV Technologies has posted results from a midphase trial of its milk allergy candidate Viaskin Milk. The study detected a statistically significant desensitization to milk among a subgroup of participants, although the overall data set leaves questions unanswered as DBV prepares to discuss the next steps with regulators.
Investigators enrolled 198 children aged 2 to 17 in the trial and randomized them to receive one of three doses of Viaskin Milk or placebo. The study aimed to show wearing a Viaskin Milk patch every day for a year desensitizes patients to milk by exposing the patients to dry milk proteins.
DBV thinks the data support this idea. The French biotech’s upbeat reading of the results is based on the performance of the 38 children aged 2 to 11 years old who received the middle, 300 µg dose of Viaskin Milk. Almost 58% of those participants were classed as responders, compared to 32.5% of the kids of the same age in the placebo cohort. That resulted in a p value of 0.042.
Analysts at Jefferies called that finding “highly encouraging” and investors drove DBV’s stock up 8% in after-hours trading. Given the propensity for kids to spontaneously get over milk allergies, thereby driving up the response rate in the placebo arm, DBV faced an uphill struggle going into the trial.
Other parts of the data are less compelling, though. No dose-dependent effect was seen—the 500 µg dose struggled to beat the 150 µg regimen, let alone the 300 µg arm—and none of the doses achieved statistical significance once adolescents were factored in. Earlier communications from DBV referred to a trial of children and adolescents aged 2 to 17 but the firm split the population in two for the final analysis.
Those issues will be irrelevant if the 300 µg dose in kids aged 2 to 11 years old truly is the sweet spot for Viaskin Milk. But the noise in the data set leaves scope for doubts about how the drug will perform in a phase 3 trial. DBV plans to meet with regulators to discuss the design of that trial later this year. As it stands, the plan is to test the 300 µg dose in kids aged 2 to 11 years old.