New data: Viaskin Peanut patch improves treatment benefit through 36 months | Image Credit: © andersphoto - © andersphoto - stock.adobe.com.

Positive data from an open-label extension (OLE) study of Viaskin Peanut patch (VP250; DBV Technologies) has demonstrated continued improvement in treatment benefit among peanut-allergic toddlers aged 1 to 3 years through 36 months, according to an announcement from DBV.^1,2

The OLE study followed the phase 3 EPITOPE trial (NCT03211247), which evaluated safety and efficacy of Viaskin Peanut patch 250 µg. In the EPITOPE trial, 67% of individuals in the treatment arm met the treatment responder criteria at 12 months, compared to 33.5% of those in the placebo are (difference in response rates = 33.4%; 95% CI = 22.4% - 44.5%), respectively.²

A treatment responder was defined as either an individual with an eliciting dose (ED) ≤10 mg who reached an ED ≥300 mg of peanut protein at month 12, or an individual with a baseline ED >10 mg who reached an ED ≥1,000 mg of peanut protein at month 12.²

According to previously-announced data from DBV, the EPITOPE trial enrolled 362 children aged 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively.²

After completion of the 12 month EPITOPE trial, eligible participants could enroll in the OLE to receive a total of 36 months of treatment. Double-blind placebo-controlled food challenges (DBPCFC) were conducted at the end of each year of treatment with safety assessed throughout the entire OLE, stated DBV.¹

Participants "remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment," noted DBV in the announcement.¹

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Overall, 266 participants who completed EPITOPE enrolled in the OLE. Of these, 211 underwent the month 36 DBPCFC (n = 149 VP250; n = 62 placebo). After 36 months' treatment with Viaskin, 83.5% of participants reached an ED of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study).¹

Similarly, an increase was observed for those reaching an ED of ≥2000 mg, with 72.7% at month 36 and 37.0% at month 12, respectively.¹

Those who completed the DBPCFC without meeting stopping criteria increased from 30.7% at month 12 to 68.2% at month 36. A continued reduction in DBPCFC reaction severity occurred, with 66.5% having mild or no symptoms at month 36 vs 40.2% at month 12.¹

The data follows a December, 2024 announcement from DBV regarding alignment with the FDA on a regulatory pathway for Viaskin in those aged 1 to 3 years. The FDA formalized guidance on an Accelerated Approval for the patch, with each party having agreed on key design elements for a post-marketing confirmatory study.³

According to DBV, Accelerated Approval criteria includes³:

1. That the product candidate treats a serious condition
2. That the product candidate generally provides a meaningful advantage over available therapies
3. That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit

References:

1. DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study. DBV Technologies. January 8, 2025. Accessed January 9, 2025. https://dbv-technologies.com/press_releases/dbv-technologies-announces-positive-3-year-results-from-epitope-phase-3-open-label-extension-study/

2. DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in PeanutAllergic Toddlers. DBV Technologies. June 7, 2022. Accessed January 9, 2025. https://dbv-technologies.com/wp-content/uploads/ir/epitope-press-release-pdf.pdf

3. DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin^® Peanut Patch in Toddlers 1 – 3 Years-Old. DBV Technologies. December 11, 2024. Accessed January 9, 2025. https://dbv-technologies.com/press_releases/dbv-confirms-alignment-with-u-s-fda-on-accelerated-approval-pathway-for-the-viaskin-peanut-patch-in-toddlers-1-3-years-old/