Clinical Trials

Date: 2016-10-26

Type of information: Publication of results in a medical journal

phase: 2

Announcement: publication of results in the Journal of Allergy and Clinical Immunology

Company: Consortium for Food Allergy Research - CoFAR (USA) 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 - Immunological diseases

Country: USA

Trial details:

• The CoFAR6 study is coordinated by Dr. Hugh Sampson of The Icahn School of Medicine at Mount Sinai (NY) and Dr. Stacie Jones of Arkansas Children's Hospital. The trial will enroll 75 patients from 4 to 25 years of age in the US. Patients will be randomized to two doses of Viaskin® Peanut (100ug or 250ug) versus placebo (1:1:1). Viaskin® Peanut will be applied once a day. Clinical efficacy will be evaluated after 12 months and 30 months of treatment. Immunological status will be assessed at baseline, 1 year and 2.5 years. Safety will be monitored centrally. Dr. Sampson is also international coordinator for VIPES (Viaskin Peanut Efficacy and Safety study), DBV's global Phase IIb clinical trial to evaluate Viaskin® Peanut efficacy and safety. (NCT01904604)

Latest news:

• • On October 26, 2016, DBV Technologies announced the publication of 12-month results from CoFAR6, a Consortium of Food Allergy Research (CoFAR) study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), investigating the use of Viaskin Peanut for the treatment of peanut-allergic patients 4 to 25 years of age. The primary endpoint of the study, which measured a statistically significant desensitization to peanut, was met, with a greater clinical benefit reported in younger participants. The CoFAR6 study publication, titled Epicutaneous Immunotherapy for the Treatment of Peanut Allergy in Children and Young Adults, was published in the Journal of Allergy and Clinical Immunology (JACI).  The authors of the publication concluded that Viaskin Peanut was safe and could potentially be a convenient mode of treatment for peanut allergy. Results from the CoFAR6 study were previously announced and presented at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in March 2016 (see below).
• • On March 4, 2016, DBV Technologies announced the presentation of results from CoFAR6, showing that treatment with Viaskin® Peanut was observed to be safe and well-tolerated, and led to statistically significant desensitization in trial subjects. The 52-week CoFAR6 results were highlighted during two oral presentations at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles, CA.
• Findings from this study are consistent with clinical data trends previously observed in DBV’s Phase IIb trial, VIPES, and Assistance Publique - Hôpitaux de Paris’ Phase II study, ARACHILD. During the “Epicutaneous Peanut to Treat Peanut Allergy” presentation, Stacie M. Jones, MD, Professor of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children’s’ Hospital, Little Rock, AR, reviewed CoFAR6 trial data in which Viaskin Peanut was observed to be safe and well-tolerated across treatment groups, with no serious adverse events or epinephrine use related to treatment observed. Treatment adherence was high (97.1%), dropouts were low (8%), and no withdrawals occurred in the 250 µg treatment group.
• Cohorts treated with both Viaskin Peanut 100 µg (P=0.005), and Viaskin Peanut 250 µg (P=0.003) met the primary efficacy endpoint in all populations. The treatment response was enhanced in children four to 11 years of age, and also, with Viaskin Peanut 250 µg compared to Viaskin Peanut 100 µg. Dr. Cecilia Berin, Associate Professor Pediatrics, Mount Sinai Hospital in New York, NY, who also participated in the CoFAR6 study, presented “Insights from New Mechanistic Studies on Food Allergy”, which explored T cell profiling of peanut allergic patients. In Dr. Berin’s presentation, early findings from CoFAR6 support Viaskin Peanut’s mechanistic features that have been observed at the preclinical level. Viaskin Peanut at the 250 µg dose showed a trend of decreased Th2 cell frequency, without any increased trends in the Th1 response. In animal models, DBV has observed that Viaskin’s unique mechanism of action could rebalance the immune reaction by down-regulating the Th2 response to allergens while keeping Th1 responses balanced.
• • On October 24, 2013, DBV Technologies and the Consortium for Food Allergy Research (CoFAR) have announced that the CoFAR started enrolling patients into the CoFAR6 trial.

Is general: Yes