DBV initiates a Phase III study of Viaskin Peanut for the treatment of peanut allergic children

Published: 10-Dec-2015

During the Peanut EPIT Efficacy and Safety Study (PEPITES), patients will be assessed using a double-blind, and placebo controlled food challenge


DBV Technologies, a clinical-stage specialty biopharmaceutical company, has announced the initiation of a pivotal Phase III study designed to evaluate the safety and efficacy of Viaskin Peanut (250µg) in children aged 4-11 with peanut allergy.

The Viaskin Peanut patch is the company's lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can safely deliver biologically active compounds to the immune system through the immune cells of the intact skin.

PEPITES (Peanut EPIT Efficacy and Safety Study), is an international, randomised 2:1, double-blind, placebo-controlled Phase III study in which paediatric peanut allergic patients will be treated with Viaskin Peanut or a placebo for 12 months.

During the trial, patients' peanut allergy will be assessed using a double-blind, placebo controlled food challenge (DBPCFC) at baseline. Both the US Food and Drug Administration (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 10mg, a responder will be defined as a patient with a peanut protein ED equal to or greater than 300mg of peanut protein after 12 months of treatment. For subjects with a baseline ED greater than 10mg, a responder will be defined as a patient with a peanut protein eliciting dose equal to or greater than 1000mg of peanut protein after 12 months of treatment.

PEPITES is expected to enrol approximately 330 patients in about 30 centres across North America (Canada and the United States), Europe and Australia. Following conversations with clinical centres and regulatory agencies, the company has decided to increase the size of its Phase III study 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.

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 paediatric and adult patients that will define the efficacy and safety profile of Viaskin Peanut in a broad patient population.

Dr Pierre-Henri Benhamou, Chairman and Chief Executive Officer of DBV Technologies, said: 'During the last two decades, peanut allergic patients have been waiting for a treatment that could safely protect them against life-threatening anaphylaxis without causing dangerous side-effects. If PEPITES' results are in-line with data from our previous studies, we believe that Viaskin Peanut may be poised to be the first new therapy for safely treating peanut allergy.'

He continued: 'We are thankful for our patients, investigators and investors' support throughout this development journey. In light of the demand for the patch at our clinical centres, we anticipate that we will complete PEPITES' recruitment as originally planned, by the end of the third quarter of 2016.'

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