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The primary endpoint is based on a responder
analysis after 12 months of treatment with the selected dose of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo-controlled food challenge (DBPCFC). For patients with a baseline peanut protein eliciting dose (ED) equal to or
less than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder is defined as a patient
with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD), will also be evaluated in EPITOPE to establish the total quantity of peanut
protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers will also be measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.
Following the completion of EPITOPE, all eligible patients will have the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin
Peanut 250 µg. In the EPOPEX study, patients who were randomized to active treatment during EPITOPE will receive Viaskin Peanut 250 µg for two additional years; patients who were previously receiving placebo during EPITOPE will be
treated with Viaskin Peanut 250 µg for three years. Patients enrolling in the EPOPEX study will remain blinded to their respective treatment group in EPITOPE until the EPITOPE study results become publicly available.
About DBV Technologies
DBV Technologies is developing
Viaskin
®
, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT
®
, DBVs method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the Company
is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBVs food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of
Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has
global headquarters in Montrouge, France and New York, NY. The Companys ordinary shares are traded on segment A of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and the Companys ADSs (each representing
one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the potential of Viaskin Peanut in toddlers ages one to
three years and of the Companys clinical development and regulatory plans regarding Viaskin Peanut in this patient population. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and
uncertainties. At this stage, the products of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties
associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that results of historical clinical trials will not be replicated in future clinical trials and the risk that historical
clinical results in one patient population may not be predictive of future clinical trial results in different patient populations. A further list and description of these risks, uncertainties and other risks can be found in the Companys
regulatory filings with the French Autorité des Marchés Financiers, the Companys Securities and Exchange Commission filings and reports, including in the Companys Annual Report on Form 20-F for the year ended
December 31, 2017 and future filings and reports by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than
as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.