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
ARACHILD, a multicenter double blind placebo-controlled clinical trial was designed to assess the efficacy and safety of EPIT in 54 randomized children aged 5 to 17 with a confirmed peanut allergy. Patients with peanut allergy were tested by classical allergy tests (Prick test and IgE), and allergy was finally confirmed during a standardized double blind placebo-controlled food challenge (DBPCFC). Subjects who reacted to a cumulative dose of peanut proteins <300mg were eligible and were randomized to either Viaskin Peanut patch dosed at 100µg of peanut proteins (active group) or to Viaskin Placebo patch (Placebo group) in a 1:1 ratio.
The hospitals included in the study were: Necker Hospital for Sick Children, Paris; Lenval Hospital, Nice; Hospices Civils, Strasbourg; Saint-Vincent de Paul Hospital, Lille; and, Central Hospital, Nancy, France. Viaskin was applied daily until a second DBPCFC after 6 months of treatment (in an 18-month treatment scheduled trial). Specific IgE (Immunoglobulin E) and IgG4 (Immunoglobulin G4), key indicators of the desired immune response, were monitored at specific time points over the treatment period.
The mean ± standard deviation (sd) cumulated reactive dose of peanut at entry was 65.8±88.8mg (active group) and 81.87±104.59mg (placebo group). During the DBPCFC after 6 months of treatment, 18.5% of patients in the active group multiplied by ?10-fold the cumulated reactive dose of peanut proteins versus 0% patients in the placebo group (Fisher's exact test, p=0.05).
Important immunologic changes occurred in the active group within 6 months: the mean net increase ± sd and median net increase of peanut-specific IgE were 92.8±136 and 30.2KU/L (active) vs 30.8±145 and 1.8 KU/L(placebo)respectively; (Wilcoxon test,>± sd and median net increase of peanut-specific IgG4 were 0.92±1.2 and 0.6 mg/L (active) vs 0.1±0.65mg/L and 0 mg/L (placebo) respectively;(Wilcoxon test, p<0.0001).
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