VP250 Is Safe and Effective Treatment for Young Children With Peanut Allergy

Author(s):

Gillian McGovern, Associate Editor

Key Takeaways

VP250 treatment in young children with peanut allergies showed increased efficacy over 24 months, with 81.3% reaching an eliciting dose of at least 1000 mg.
No new safety signals were observed, and fewer application site reactions occurred in the second year of treatment.
Placebo-treated patients who switched to VP250 showed consistent results, with 62.7% reaching an eliciting dose of at least 1000 mg.
Serious treatment-related adverse events and anaphylaxis were rare, occurring in 0.4% and 1.6% of the VP250 group, respectively.

In children aged 1 to 3 years, the VP250 peanut patch was superior to placebo in the desensitization to peanuts and increasing the peanut dose that triggers allergic symptoms.

Results from the phase 3 EPITOPE clinical trial (NCT03211247)¹ show that 2 years of treatment with VP250 (Viaskin Peanut Patch 250 μg; DBV Technologies) led to continued treatment effect increases without new safety signals in young children allergic to peanuts. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children, the authors noted.²

This analysis was the open-label extension of a double-blind, placebo-controlled, randomized phase 3 trial. A total of 266 participants with peanut allergies aged 1 to 3 years were included in this portion of the trial. Patients were randomly assigned to receive either once-daily VP250 or a placebo patch.^1,2

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The primary end point was the percentage of treatment responders at month 12, which was defined as the initial eliciting dose (ED) greater than 10 mg peanut protein and the ED was at least 1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at month 12, or the initial ED at baseline was 10 mg peanut protein or less and the ED was at least 300 mg peanut protein at the post-treatment DBPCFC at month 12. Secondary end points included the following: cumulative reactive dose (CRD) of peanut protein and change from baseline in CRD; ED of peanut protein and change from baseline in ED; and percentage of patients with severity of objective symptoms at baseline and month 12.¹

The findings show that 244 patients underwent month 24 DBPCFC (VP250: n = 166; placebo: n = 78). After 24 months, approximately 81.3% of patients on VP250 reached an ED of at least 1000 mg, 63.8% reached at least 2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. Additionally, no treatment-related anaphylaxis or serious treatment-related adverse events (AEs) had occurred during year 2 in this cohort. The authors also observed fewer application site reactions during year 2 compared with year 1.²

Additionally, placebo-treated patients who received 1 year of open-label VP250 were consistent with earlier treatment results. Approximately 62.7% reached an ED of at least 1000 mg, 36.5% at least 2000 mg, and 28.4% completed the DBPCFC. There was 1 recorded treatment-related anaphylaxis event.²

Results from an earlier analysis³ featuring 362 patients showed that approximately 67.0% of patients receiving VP250 had reached the primary efficacy end point compared with 33.5% of those in the placebo group (risk difference: 33.4% [95% CI, 22.4 to 44.5]; P < .001). AEs were observed in all patients receiving VP250 compared with 99.2% of those receiving placebo; however, not all of these were believed to be directly related to treatment.³

About the Trial

Trial Name: Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE)

ClinicalTrials.gov ID: NCT03211247

Sponsor: DBV Technologies

Completion Date: April 27, 2022

Serious AEs occurred in about 8.6% and 2.5% of those in the VP250 and placebo groups, respectively. Anaphylaxis occurred in 7.8% and 3.4% of the patients in their respective groups. Serious treatment-related AEs and treatment-related anaphylaxis occurred in 0.4% and 1.6% of patients in the intervention group. Neither serious treatment-related AEs nor treatment-related anaphylaxis occurred in the placebo group.³

The analyses demonstrated that 12 and 24 months of VP250 in children aged 1 to 3 years with peanut allergy was superior to placebo in the desensitization of peanuts and increasing the peanut dose that initially triggered allergic symptoms. These analyses also did not present any new safety signals.^1,3

REFERENCES

1. Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE). ClinicalTrials.gov identifier: NCT03211247. Updated December 16, 2024. Accessed February 14, 2025. https://clinicaltrials.gov/study/NCT03211247

2. Greenhawt M, Albright D, Anvari S, et al. Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE. JACI: In Practice. 2025. doi:10.1016/j.jaip.2025.02.004

3. Greenhawt M, Sindher SB, Wang J, et al. Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy. NEJM. 2023;388(19):1755-1766 doi:10.1056/NEJMoa2212895