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Montrouge, France

Key Takeaway: DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin Peanut in Toddlers DBV Technologies (Euronext: DBV ISIN: FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today anno

Full Press Release Details

DBV Technologies Announces 2-Year Results from Ongoing
Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin Peanut in Toddlers
DBV Technologies (Euronext: DBV ISIN:
FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive interim results from its ongoing Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of Viaskin Peanut 250 g [VP250] in toddlers ages 1 to 3 years), which is named EPOPEX. After completing participation in the EPITOPE study, eligible subjects could enroll in EPOPEX to receive a
total of three years of Viaskin Peanut treatment. Double-blind placebo-controlled food challenges (DBPCFC) are conducted at the end of each year of treatment with safety assessed throughout the entire OLE. Importantly, all subjects remained blinded
to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment.
Twelve-Month EPITOPE OLE Interim Results:
We are thrilled with
the results generated from the two-year open-label extension to the Phase 3 EPITOPE trial. This OLE aimed to evaluate the continued efficacy, safety, and tolerability of Viaskin Peanut in toddlers in a
real-world setting, stated Daniel Tass , Chief Executive Officer of DBV Technologies. The data show that nearly 56% of subjects were able to consume a cumulative dose of 12 14 peanut kernels without meeting
the pre-defined stopping criteria and more than 81% of subjects reached an equivalent eliciting dose of 3 4 peanut kernels. Recall that these are toddlers that began the study with an equivalent eliciting dose ranging from fractions of a
peanut kernel to roughly one peanut kernel. This is a promising outcome for a community of peanut allergic toddlers where accidental exposure poses significant risk, and the current best practice avoidance places a daily burden on
patients and families. These data further our belief that Viaskin Peanut has the potential to be the first FDA approved treatment for peanut allergic toddlers.
The interim data from the EPOPEX OLE will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific
Meeting, which is being held November 9-13, 2023, in Anaheim, CA. The data were submitted in as a late-breaking abstract and accepted for an oral abstract presentation.
The presentation and abstract details interim 12-month results from subjects previously enrolled in EPITOPE, a
study of one year of epicutaneous immunotherapy with a patch containing 250 g of peanut protein vs a placebo patch. The EPITOPE study resulted in a statistically significant treatment response vs placebo in 1-3-year-old peanut-allergic toddlers, as featured in a New England Journal of Medicine publication and editorial
These interim data from the first 12 months of follow-up from the OLE
demonstrate that Viaskin Peanut continued to generate a treatment effect beyond what was observed in EPITOPE, stated Dr. Matthew Greenhawt, Children s Hospital Colorado, lead author and study
investigator. As a clinician, I am pleased that Viaskin Peanut showed improvement
between months 12 and 24 of treatment across all evaluated efficacy parameters. It is even more encouraging that this was achieved with no new safety signals and with fewer local application site
reactions in year two versus year one. I look forward to progressing the EPITOPE OLE to its conclusion with the goal of assessing the long-term efficacy, safety, and tolerability of Viaskin Peanut.
Late-Breaking Abstract (poster presentation):
EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: 1-year
Open-Label Extension to EPITOPE
On behalf of the food allergy community, we are so pleased to see the results from the open-label extension to the EPITOPE study said
Eleanor Garrow-Holding, CEO, Food Allergy and Anaphylaxis Connection Team. Patients and families are eagerly awaiting FDA-approved options that may be appropriate for their unique medical
needs and lifestyle. Viaskin Peanut, if approved, has the potential to be an efficacious and well-tolerated treatment with a promising safety profile. We look forward to DBV s continued regulatory progress and the initiation of the COMFORT
Toddlers safety study to support a future BLA submission and FDA s potential review of this innovative product.
Conference Call and Webcast
DBV management will host an investor conference call and webcast today, November 9th, at 5:00pm EST, to discuss the EPOPEX data. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
A live webcast of the call will be available on the Investors & Media section of the
Company s website: https://www.dbv-technologies.com/investor-relations/. A replay of the
presentation will also be available on DBV s website after the event.
About DBV Technologies
DBV Technologies is developing Viaskin , an investigational proprietary technology platform
with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT , and is DBV Technologies method of delivering biologically active compounds
to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies food
allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company s ordinary shares are traded on segment B of
Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
press release may contain forward-looking statements and estimates, including, but not limited to, statements regarding the therapeutic potential of Viaskin Peanut and EPIT and DBV s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, and the ability of any of DBV s product candidates, if
approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV s product candidates have not been
authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or project herein include uncertainties associated generally with research and development, clinical trials and related
regulatory reviews and approvals. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth herein can be found in DBV Technologies regulatory filings with the
Autorit des March s Financiers ( AMF ), DBV Technologies filings and reports with the U.S. Securities and Exchange Commission ( SEC ), and future filings and reports made with the AMF and SEC. 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.
Viaskin and EPIT are trademarks of DBV Technologies.
Last updated: Nov 9, 2023