DBV Technologies announced positive topline results from the phase 3 PEOPLE trial of Viaskin Peanut for the treatment of peanut-allergic children aged 4 to 11 years.
Viaskin Peanut is an epicutaneous immunotherapy (EPIT) that delivers small amounts of peanut protein through a wearable patch to induce desensitization. The PEOPLE trial is an ongoing, open-label extension study of the phase 3 PEPITES trial evaluating the long-term safety, tolerability and efficacy of Viaskin Peanut 250mcg in 141 children aged 4 to 11 years. At Month 36, the eliciting dose was assessed using a double-blind, placebo-controlled food challenge with patients receiving an initial dose of 1mg of peanut protein escalating to the highest dose of 2000mg (maximum total cumulative dose of 5444mg).
Results showed that after 36 months of treatment, 51.8% (n=73) of patients reached an eliciting dose of ≥1000mg peanut protein compared with 40.4% (n=57) at Month 12 (primary end point); the mean cumulative reactive dose was 1768.8mg at Month 36 vs 223.8mg at baseline. Moreover, 19 patients (13.6%) completed the food challenge, reaching a cumulative dose of 5444mg.
After 36 months, patients who reached an eliciting dose of ≥1000mg were eligible to continue the study for an additional 2 months without treatment while maintaining a peanut-free diet. Analysis showed that 77.8% of patients (14 out of 18) maintained desensitization with an eliciting dose ≥1000mg at Month 38.
With regard to safety, the most common treatment-emergent adverse events were mild to moderate skin reactions localized to the administration site (epinephrine use was not necessary).
“These new long-term data support the overall clinical benefit of Viaskin Peanut that we’ve observed to date in phase 2 and 3 clinical trials. We are particularly pleased to see that approximately 3 out of 4 patients showed an increase in their eliciting dose over 3 years, regardless of their individual baseline, with roughly 1 in 7 patients able to consume 5444mg peanut protein without reacting during the Month 36 oral food challenge,” said Dr David Fleischer, Principal Investigator of PEPITES and PEOPLE, Director, Allergy and Immunology Center and Section Head, Children’s Hospital Colorado.
In October 2019, the FDA accepted for review the Biologics License Application (BLA) for Viaskin Peanut. A Prescription Drug User Fee Act date of August 5, 2020 has been set for this application.
For more information visit dbv-technologies.com.