Allergies, Author Interviews / 22.01.2020

MedicalResearch.com Interview with: 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). (more…)
Allergies, Author Interviews, Pediatrics / 04.03.2019

MedicalResearch.com Interview with: Todd Green MD  Vice President, Medical Affairs North America DBV Technologies Associate Professor of Pediatrics University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this announcement? What is Viaskin Peanut? Response: Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening allergic reactions, including anaphylaxis. Unfortunately, there are no FDA-approved treatment options for peanut or other food allergies – leaving patients with avoidance and readiness to manage reactions to accidental exposures as their only option. Viaskin Peanut uses epicutaneous immunotherapy or EPIT, a method of delivering biologically active compounds to the immune system through the skin. Patients receive about 1/1,000th of a peanut with each daily dose of peanut protein – the equivalent of one peanut every three years – which activates the immune system with very minimal exposure. In February 2019, DBV announced that its planned resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019. DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families. Viaskin Peanut previously received Breakthrough and Fast Track designations for the treatment of peanut-allergic children from the FDA in 2015 and 2012, respectively.  (more…)