Date: 2015-07-12
Type of information: Initiation of the trial
phase: 3 - pediatric
Announcement: initiation of the trial
Company: DBV Technologies (France)
Product: Viaskin® Peanut
Action
mechanism: immunotherapy product. Viaskin® is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream. Viaskin® Peanut is currently being investigated in clinical trials for treatment of peanut allergy.
Disease: peanut allergy
Therapeutic area: Allergic diseases
Country: Australia, Canada, Germany, Ireland, USA
Trial
details: PEPITES (Peanut EPIT® Efficacy and Safety Study) is planned as a randomized, double-blind, placebo-controlled pivotal Phase III trial designed to assess the efficacy and safety of Viaskin Peanut 250 ?g in approximately 330 patients in about 30 centers across North America (Canada and the United States), Europe, and Australia.. Patients will be randomized 2:1 to receive either Viaskin Peanut 250 ?g or placebo for 12 months. This planned Phase III trial is designed to confirm with appropriate statistical considerations in children aged 4 to 11, Viaskin Peanut's treatment effect that was shown during the Phase IIb VIPES trial, while providing sufficient safety data to support initial registration fillings in this patient population.
During the study, patients will be assessed using a double-blind, and placebo controlled food challenge (DBPCFC). Patients will be randomized 2:1 to receive either Viaskin Peanut 250 ?g or placebo for 12 months. The combined primary endpoint is based on a responder analysis after 12 months of treatment with Viaskin Peanut 250 µg. For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For subjects with a baseline ED greater than 10 mg, a responder will be defined as a patient with a peanut protein eliciting dose equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD) will also be used in PEPITES to establish the total quantity of peanut protein that triggers patient reactions at month 12 versus placebo. Serological markers will also be measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.
Latest
news: * On July 12, 2015, DBV Technologies announced the initiation of a pivotal Phase III study designed to evaluate the safety and efficacy of Viaskin® Peanut 250 ?g in children ages 4 to 11 with peanut allergy. During the trial, patients’ peanut allergy will be assessed using a double-blind, placebo controlled food challenge (DBPCFC) at baseline. Both the FDA and the European Medicines Agency (EMA) have agreed to a combined primary endpoint based on a responder analysis after 12 months of treatment. For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder will be defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For subjects with a baseline ED greater than 10 mg, a responder will be defined as a patient with a peanut protein eliciting dose equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. Following conversations with clinical centers and regulatory agencies, the company has decided to increase the size of its Phase III study in order to meet patient and investigator demand for Viaskin Peanut, as well as further strengthening the study’s ability to detect a clinically meaningful and statistically significant effect of Viaskin Peanut 250 ?g. PEPITES is designed to confirm Viaskin Peanut’s treatment efficacy as shown in VIPES and OLFUS-VIPES, the company’s Phase IIb and open label follow-up studies. DBV also intends, following additional consultation with regulatory agencies, to conduct additional clinical trials, notably in both pediatric and adult patients that will define the efficacy and safety profile of Viaskin Peanut in a broad patient population. The company expects to complete PEPITES’ recruitment by the end of the third quarter of 2016. * On June 23, 2015, DBV Technologies announced the completion of its End-of-Phase II meeting with the FDA. The outcome of this meeting on the clinical development plan for Viaskin® Peanut is consistent with the previously announced positive opinion of the Paediatric Committee of the European Medicines Agency (EMA) on Viaskin Peanut's Paediatric Investigation Plan (PIP). Based on these regulatory consultations, DBV Technologies plans to initiate a global Phase III trial with Viaskin Peanut for the treatment of peanut allergic children 4 to 11 years of age in the fourth quarter of 2015. Based on these consultations, additional development plans for Viaskin Peanut in younger and older patients will be discussed with the FDA in the second half of 2015. * On June 4, 2015, DBV Technologies has announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) adopted a positive opinion agreeing the company’s PIP for Viaskin® Peanut. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in pediatric population. An accepted PIP is a prerequisite for the filing for marketing authorization for any new medicinal product in Europe. DBV Technologies’ PIP provides a comprehensive clinical development plan for Viaskin® Peanut in pediatric population from 1 to 17 years of age, in particular the features of the phase III program in children. The positive opinion on the Company’s PIP already takes into account the statistically significant Phase IIb trial results with Viaskin Peanut. The Viaskin® Peanut Efficacy and Safety trial, or VIPES, is a Phase IIb study demonstrating that Viaskin Peanut 250?g improved the peanut allergy disease in children. Available safety data from past and ongoing studies with Viaskin Peanut demonstrate a robust safety profile in children, adolescents and adults.
In children 4-11 years of age, the anticipated Phase III trial, Peanut EPIT® Efficacy and Safety Study (PEPITES) is expected to begin in the fourth quarter of 2015 following the submission of the final clinical trial protocol and updated chemistry, manufacturing and controls information, and review by the FDA, as well as review and approval of Clinical Trial Applications in the other countries where the trial is expected to be conducted. In addition to the planned pivotal study in peanut allergic children aged 4 to 11, which is essential to support initial European Marketing Authorization Application (MAA) and initial US Biologics License Application (BLA) filings, DBV also intends to conduct additional separate clinical trials in younger and older patients. DBV expects that further regulatory consultation will help to optimize the clinical development plan for assessing safety and efficacy of Viaskin Peanut in these patient populations. In the fourth quarter of 2015, DBV expects to report the first year of follow-up data from the OLFUS-VIPES clinical trial, which is an extension trial for subjects having completed the VIPES trial, during which all patients are under active Viaskin Peanut treatment. The OLFUS-VIPES clinical trial includes 171 patients at 21 sites in North America and Europe, representing 83% of the patients who completed 12 months of therapy in the VIPES trial. Clinical data from a National Institutes of Health sponsored study, CoFAR6, using Viaskin Peanut, is also expected to be reported in late 2015 or early 2016. This study may be important in describing the mechanism of action of epicutaneous immunotherapy (EPIT®) in humans.
