DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin Peanut in Toddlers - Seite 2

“We are thrilled with the results generated from the two-year open-label extension to the Phase 3 EPITOPE trial. This OLE aimed to evaluate the continued efficacy, safety, and tolerability of Viaskin Peanut in toddlers in a real-world setting,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “The data show that nearly 56% of subjects were able to consume a cumulative dose of 12 – 14 peanut kernels without meeting the pre-defined stopping criteria and more than 81% of subjects reached an eliciting dose of 3 – 4 peanut kernels. Recall that these are toddlers that began the study with an equivalent eliciting dose ranging from fractions of a peanut kernel to roughly one peanut kernel. This is a promising outcome for a community of peanut allergic toddlers where accidental exposure poses significant risk, and the current best practice – avoidance – places a daily burden on patients and families. These data further our belief that Viaskin Peanut has the potential to be the first FDA approved treatment for peanut allergic toddlers.”

The interim data from the EPOPEX OLE will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, which is being held November 9-13, 2023, in Anaheim, CA. The data were submitted in as a late-breaking abstract and accepted for an oral abstract presentation.

The presentation and abstract details interim 12-month results from subjects previously enrolled in EPITOPE, a study of one year of epicutaneous immunotherapy with a patch containing 250 µg of peanut protein vs a placebo patch. The EPITOPE study resulted in a statistically significant treatment response vs placebo in 1-3-year-old peanut-allergic toddlers, as featured in a New England Journal of Medicine publication and editorial in May 2023.
  
“These interim data from the first 12 months of follow-up from the OLE demonstrate that Viaskin Peanut continued to generate a treatment effect beyond what was observed in EPITOPE,” stated Dr. Matthew Greenhawt, Children’s Hospital Colorado, lead author and study investigator. “As a clinician, I am pleased that Viaskin Peanut showed improvement between months 12 and 24 of treatment across all evaluated efficacy parameters. It is even more encouraging that this was achieved with no new safety signals and with fewer local application site reactions in year two versus year one. I look forward to progressing the EPITOPE OLE to its conclusion with the goal of assessing the long-term efficacy, safety, and tolerability of Viaskin Peanut.”