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
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
ARACHILD, a remarkable public-private collaboration