DBV Technologies ($DBVT) has posted a look at data from a two-year follow-up to a Phase IIb trial of its peanut allergy patch. Response rates remain above 80% among children who have received three years of treatment with the 250-μg formulation, and median compliance across the study continues to hover around 96%.
When the Phase IIb trial ended, DBV enrolled 21 of the 28 children who received the 250-μg Viaskin Peanut formulation during the study into a follow-up program. After losing one patient to follow-up during the first stage of the extension, DBV closed out the first year of the study with a response rate of 80% among this group.
In the second year, DBV lost track of another three patients--something it says was unrelated to the drug--and emerged with a response rate of 83%. The mean and median cumulative reactive dose (CRD) of peanut protein, respectively, rose and stayed constant over the course of the second year. DBV also reported the maintenance of peanut-specific immunoglobulin E levels and continued high levels of immunoglobulin G4, although it has yet to provide numbers on either.
Paris-based DBV also looked at what happens when patients who have become unresponsive to a CRD of 1,440 mg or more of peanut protein stop taking Viaskin Peanut. The top-line finding is that all 19 of the children were still unresponsive to a CRD of 1,440 mg two months after stopping treatment, suggesting the response to the drug may be durable.
DBV plans to share full details of the analysis and other aspects of the follow-up data at a medical meeting down the line. But, even with the gaps, the findings add to evidence that the patch can deliver long-lasting benefits to children who are allergic to peanuts. Shares in DBV rose 7% in Paris on the back of the data drop.
The big test of the candidate is still to come. DBV is penciled in to post data from a pair of Phase III trials in the second half of next year. Those studies are looking at the 250 μg formulation of Viaskin Peanut in children aged four to 11 years old, a similar demographic to that assessed in the follow-up trial. If those trials are successes, the follow-up data could help DBV as it tries to differentiate Viaskin Peanut from Aimmune Therapeutics’ ($AIMT) rival program.