DBV Technologies’ Viaskin safe and effective in treating children with peanut allergy

Published on June 18, 2012 at 3:09 AM · No Comments

DBV Technologies (Paris:DBV) (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>. Viaskin® Peanut also showed highly significant immunological changes (secondary efficacy endpoints), with an increase of peanut-specific IgE (immunoglobulin E)> Professor Christophe Dupont, main Investigator of ARACHILD study and co-founder of DBV Technologies said: "This is the first time a treatment seems to act on food allergy without risk for the patient since there is no oral intake of the offending food at all."

Pierre-Henri Benhamou, M.D., Chairman and CEO of DBV Technologies said: "The results of the ARACHILD study, coordinated by Professor. Christophe Dupont, and sponsored by our partner AP-HP are very encouraging and promising. Beyond the statistical significance for desensitization between the treated group and the placebo group, biological data show that Viaskin® triggers a strong immune response starting early. This is even more true as the ARACHILD results are statistically significant on a very severely allergic patient population, treated at a low dose (100 μg) for only 6 months. We believe this important set of data is another step in the right direction in demonstrating that the Viaskin® platform will be a new treatment paradigm in desensitization, notably in children and adolescents with severe food allergy, thereby opening up a decisive new approach for the treatment of a high unmet medical need."

ARACHILD, a remarkable public-private collaboration

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