Promising safety and efficacy interim clinical results after 6 months of treatment in peanut-allergic children using Viaskin® Peanut presented at the European Academy of Allergy and Clinical Immunology EAACI
BAGNEUX, France, June 18, 2012- DBV Technologies (Euronext: DBV - ISIN: FR0010417345), creator of Viaskin®, a new standard in the treatment of allergy, announced today that AP-HP (Assistance Public - Hôpitaux de Paris) sponsor of the ARACHILD study presented at the EAACI Congress a late breaking oral presentation on safety and efficacy data after six months of epicutaneous immunotherapy in peanut allergy using Viaskin® Peanut. Peanut allergy is a potential life threatening disease for millions of people without any available effective medical treatments. DBV Technologies is developing Viaskin® Peanut for the global market with several ongoing clinical studies in both Europe and in the US.
The ongoing ARACHILD study which is a multicenter double blind placebo-controlled 18 month clinical trial is designed to assess the efficacy and safety of Viaskin® Peanut in 54 randomized children aged 5 to 17 years with a confirmed peanut allergy. Importantly, the 6 months interim data show no drop-out of patients from the study due to adverse events or any serious adverse events related to the treatment.
The interim data also show statistically significant efficacy of Viaskin® Peanut versus placebo on the primary efficacy endpoint of the study. Results show that 18.5% of patients in the treated group were able to consume at least 10-fold more peanut at the 6-month oral food challenge vs 0% in the placebo group (p=0.05). Viaskin® Peanut also showed highly significant immunological changes (secondary efficacy endpoints), with an increase of peanut-specific IgE (immunoglobulin E) (p= 0.036) and peanut-specific IgG4 (immunoglobulin G4) (p<0.0001). IgG4 increase may be considered as an indicator during immunotherapy of successful desensitization and induction of tolerance to the peanut allergen. Detailed results are highlighted below.
