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DBV Announces the First reported case of a long term sustained effect of Peanut desensitization after Epicutaneous Immunotherapy (EPIT) with Viaskin(R) at the French Congress of Allergy

  • Dr. Thierry Bourrier and Pr. Christophe Dupont present abstract showing that a peanut-allergic child from the ARACHILD study had a sustained desensitization even after one year off treatment
  • Multiple Oral Presentations on EPIT at the French Congress of Allergy

BAGNEUX, France, April 16, 2014 (GLOBE NEWSWIRE) -- DBV Technologies (Euronext: DBV - ISIN: FR0010417345), creator of Viaskin®, a new paradigm for the treatment of allergies, today announced that 4 communications were presented at the French Congress of Allergy (CFA). This year, highlights included an abstract authored by Dr. Bourrier from Pediatric Hospital in Nice (CHU-LENVAL) and Pr. Dupont from Assistance Publique Hôpitaux de Paris (AP-HP) at the CFA in Paris, April 15-18, 2014 reporting for the first time that a case subject from the ARACHILD Phase II study after an 18-month EPIT treatment maintained its desensitization level after one year off-treatment, with a strict peanut diet. A dedicated plenary session "Specific Epicutaneous Immunotherapy" will also take place at this congress on April 16 from 2:30 to 4:00 pm, and one presentation on DBV's EPIT cellular mechanism will be featured.

Summary of Poster from Dr. Bourrier and Pr. Dupont

The Abstract highlights an 8-year-old patient from the ARACHILD trial, who voluntarily stopped the EPIT treatment after reaching 1,146mg peanut protein (4 to 5 peanuts) during the 18-month food challenge, from 96,33 mg peanut protein at entry (1/3 peanut). After 12 months of no treatment and following a strict non-peanut diet, the child performed another food challenge and was able to reach again a cumulative reactive dose of 1,110 mg peanut protein. Both investigators concluded that this case is the first documented case in humans of a persistent efficacy induced by EPIT despite a continued and prolonged absence of exposure with the allergen after immunotherapy.

Pierre-Henri Benhamou , Chairman & CEO of DBV Technologies, said : "DBV has already demonstrated at the research level the immunomodulation impact of EPIT, generating a strong and long-lasting positive response. Thanks to Dr. Bourrier and Pr. Dupont, we are continuing to accumulate evidence on the strength of EPIT's mechanism of action. This first human case of sustained maintenance is very encouraging for patient suffering from life-threatening allergies."

ARACHILD, a multicenter double blind, placebo-controlled clinical trial conducted and sponsored by AP-HP was designed to assess the efficacy and safety of EPIT using DBV's Viaskin Peanut in 54 randomized peanut-allergic subjects from ages 5 to 17. Patients who reacted to a cumulative dose of peanut proteins of less than 300mg (equivalent of one peanut) were eligible and randomized 1:1 to either Viaskin Peanut at 100µg peanut protein dose (active group) or to Viaskin Placebo (placebo group). At Month 6, the placebo patients were all switched to active treatment. Treatment was continued up to Month 18 for all subjects. Patients who were able to consume at least 10 times more peanut protein than at the beginning of the trial and/or reached the cumulative reactive dose of more than 1000mg of peanut protein were considered a success (equivalent to 4 peanuts).

Summary from CFA 2014 Presentations and Recent Scientific Publications

Epicutaneous immunotherapy (EPIT) allows to safely treat life-threatening allergies, notably in pediatric patients, potentially inducing a powerful, long lasting and protective immune response. During an oral presentation, Dr. Vincent Dioszeghy will explain the mechanisms resulting into specific cellular induction via T-regulatory cells (T-reg). Compared to sublingual immunotherapy (SLIT), EPIT induces a different T-reg phenotype, which in turn could have positive consequences on the induction of long-term protection against sensitization to other allergens.

A recent scientific publication in Clinical and Experimental Allergy, "The regulatory T cells induction by Epicutaneous immunotherapy is sustained and mediates long term protection from eosinophilic disorders in peanut sensitized mice", shows that the protection induced by EPIT is T-reg dependent. EPIT modulates the allergen-specific T cell response via a mechanism that seems to differ from other specific immunotherapy routes, supporting a promising and long-lasting treatment effect in food allergies.

About DBV Technologies

DBV Technologies is opening up a decisive new approach to the treatment of allergy - a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people and thus constitute a major unmet medical need. DBV Technologies has developed a unique, proprietary, worldwide-patented technology for administering an allergen to intact skin and avoiding massive transfer to the blood. The Viaskin® technology combines efficacy and safety as part of a treatment that seeks to improve the patient's tolerability of peanut and thus considerably lower the risk of a systemic, allergic reaction in the event of accidental exposure to the allergen. The company's significant development program has taken this revolutionary method through to the industrial stage in Europe, initially. The product's clinically proven safety of use enables the application of effective desensitization techniques (the efficacy of which is acknowledged worldwide) in the most severe forms of the allergy. DBV Technologies is focusing on food allergies (milk and peanut) for which there are currently no effective treatments. It has developed two products: Viaskin® Peanut and Viaskin® Milk. The clinical development program for Viaskin® Peanut has received Fast Track designation from the US Food and Drug Administration. The company will subsequently develop a Viaskin® patch for young children with house dust mite allergy - a true public health issue because this pathology is one of the main risk factors for childhood asthma. DBV Technologies shares are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345).
For more information on DBV Technologies, please visit our website: www.dbv-technologies.com
CAUTION: Viaskin® is not approved for sale in the USA.

Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Company's management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Company may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Company cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. DBV technologies' business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

DBV Technologies Contacts

David Schilansky
Chief Financial Officer
Tel. : +33(0)1 55 42 78 75
david.schilansky@dbv-technologies.com

Susanna Mesa
VP Finance, US Investor Relations & Strategy
Tel. : +1 917-346-3447
susanna.mesa@dbv-technologies.com

DBVDBV IR and Media Contacts

Nathalie Donne
Director, Business Development & Corporate Communications
Tel. : +33(0)1 55 42 78 72
nathalie.donne@dbv-technologies.com

Todd James
U.S. Investor Relations
The Trout Group
Tel. : +1 646-378-2926
tjames@troutgroup.com
BMC Communications
Media Relations
Brad Miles
Tel. : +1 646-513-3125
brad@bmccommunications.com

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First reported case of a long term sustained effect after EPIT http://hugin.info/156437/R/1777488/606734.pdf

HUG#1777488

Source:DBV Technologies