22 Jan Long-Term Data from PEOPLE Phase III Study of Viaskin Peanut in Children with Peanut Allergy
MedicalResearch.com Interview with:
Dr. Campbell
Dr. Dianne Campbell, MBBS, FRACP, PhD
VP, Global Medical Affairs
DBV Technologies
MedicalResearch.com: What is the background for this study?
Response: The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg (NCT03013517) in peanut-allergic children ages 4 to 11 years . Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously receiving placebo are eligible to receive up to five years of treatment.
The current study reports on the 3 year outcomes of children who were initially randomized to receive active treatment in the PEPITES study and completed an additional 2 years of treatment during the PEOPLE study. The study evaluated the eliciting dose (ED) after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge was 1 mg of peanut protein and escalated to the highest dose of 2,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 5,444 mg peanut protein. All participants who reached an ED ≥ 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind placebo-controlled food challenge to determine ED was administered at the end of this period (Month 38).
Additional analyses include exploratory assessments of safety parameters, immune biomarkers such as immunoglobulin G4 (IgG4) and immunoglobulin E (IgE).
MedicalResearch.com: What are the main findings?
Response: The PEOPLE trial represents the largest long-term trial evaluating peanut allergy immunotherapy to date, with high compliance enabling extended study participation.
Of the 213 patients who were randomized in the active treatment arm of PEPITES and completed the 12-month trial, 198 patients opted to enter the PEOPLE study (safety population). Of these patients, 148 were considered completers after 36 months and 141 patients completed all treatment according to the study protocol without major deviations. Efficacy data were analyzed from these 141 patients (per-protocol).
In the study, approximately 3 out of 4 patients experienced an increase in their ED from baseline (month 0), showing a majority of patients benefited from the investigational therapy
- 78.0% maintained or improved the treatment effect observed at Month 12 following 2 additional years of therapy
- 51.8% reached an ED of at least 1,000 mg peanut protein (about three peanuts)
- Robust treatment response after 36 months, with 13.5% of patients tolerating a cumulative dose of 5,444 mg
- At Month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.
77.8% (14/18) demonstrated sustained unresponsiveness, defined by maintaining an ED ≥ 1,000 mg following a 2-month period without Viaskin Peanut treatment, suggesting that desensitization may be maintained after discontinuing treatment
Safety profile was consistent with previously-published controlled Phase 3 studies
- Viaskin Peanut was observed to be well-tolerated over the three-year treatment period
- No treatment-related epinephrine use reported in PEOPLE
- Consistent results observed throughout Phase II and Phase III clinical studies
MedicalResearch.com: What should readers take away from your report?
Response: DBV has completed the largest long-term trial in peanut allergy immunotherapy. We believe this study is critical to supporting the long-term treatment effect of Viaskin Peanut and has potential implications for real world use, if approved. Our mission has always been to deliver a safe, effective and enduring solution for children and families bearing the substantial burden of food allergy. Additionally, these results support the potential of Viaskin Peanut in offering long-term protection against the risk of reaction from accidental exposure and sustained desensitization.
MedicalResearch.com: When might the FDA consider the Biologic License Application for Viaskin Peanut?
Response: Our Biologics License Application (BLA) was accepted for review by the FDA on Oct. 4, 2019, with a target action date of Aug. 5, 2020. Acceptance of the BLA does not mean that the FDA has approved any product for marketing.
We have made FDA aware that the PEOPLE top-line data will be available mid-review. Discussions are ongoing with the Agency and it is too early to comment on what additional data will be shared with FDA. We don’t anticipate these results will impact the timeline for Viaskin Peanut’s BLA since the current BLA has been accepted with the 12 month pivotal trial data set and is already under review.
MedicalResearch.com: Is there anything else you would like to add?
Response: Viaskin® Peanut is the Company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts. A non-invasive, once-daily, investigational epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to activate the immune system. Viaskin Peanut is based on investigational epicutaneous immunotherapy (EPITTM), DBV’s proprietary method of delivering biologically active compounds to the immune system through intact skin.
On October 4, 2019, the U.S. Food and Drug Administration (FDA) accepted DBV’s Biologics License Application (BLA) for Viaskin Peanut in children ages 4-11. With a review goal date of August 5, 2020, we remain on track to potentially offer this treatment for peanut-allergic children by the second half of 2020, if approved.
Citation:
DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Children with Peanut Allergy
[subscribe]
Last Modified: [last-modified]
The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.
Last Updated on January 22, 2020 by Marie Benz MD FAAD