Full Press Release Details
DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3
Open-Label Extension Study
DBV Technologies (Euronext: DBV ISIN: FR0010417345 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced
positive twenty-four month results from its Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of VIASKIN peanut 250 g [VP250] in toddlers ages 1 to 3 years). The data provide
support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters.
announced today new Viaskin Peanut Patch efficacy and safety data based on average daily wear time from the EPITOPE study that is supportive of the Company s VIASKIN peanut labeling strategy, proposed to FDA in June 2024. This post-hoc analysis identified subjects on Viaskin Peanut with low or high day-to-day variability in daily wear time during the first 90
days on treatment a highly predictive marker of the average daily wear time (ADWT) during the course of the 12-month study. Subjects with low day-to-day variability in daily wear time had higher ADWT which correlated with a more robust efficacy response at 12 months.
These data are being presented in multiple poster presentations at the Eastern Food Allergy &
Comorbidity Conference, which is being held January 9th through 12th, 2025, in Palm Beach, Florida.
Twenty-Four Month EPITOPE OLE Results
participation (12 months) in the EPITOPE study, eligible subjects could enroll in the OLE to receive a total of 36 months of VIASKIN peanut treatment. Double-blind placebo-controlled food challenges (DBPCFC) were 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.
In the EPITOPE OLE, VIASKIN Peanut data suggests further improvement through 36
months of treatment across all efficacy parameters. Key data highlights include:
The compelling results from 36 months of
Viaskin Peanut treatment demonstrate a continuation of the very positive efficacy and safety trends that have been previously observed in this study, said Pharis Mohideen, Chief Medical Officer, DBV Technologies. Notably,
the data indicates that continued treatment with VIASKIN Peanut resulted in further improvement across all efficacy parameters in the second year of the OLE with no new safety signals. The data show that more than
two-thirds of subjects completed the food challenge without meeting pre-defined stopping criteria, consuming the equivalent of
12-14 peanut kernels, and more than 83% reached an ED of 1,000mg, or the equivalent of 3-4 peanut kernels. Recall that this is a patient population
that can experience devastating consequences from accidental exposure to just fractions of a peanut kernel. As we prepare to initiate the COMFORT Toddlers supplemental safety study, one of the final steps to support a BLA submission, these results
remind us of the tremendous potential of VIASKIN Peanut as a game changer for the peanut allergy community.
Shared decision making for best
response based on patch wear experience.
DBV also announced today new data from the Phase 3 EPITOPE study that supports the labeling approach that was
proposed to FDA in June 2024. Patch wear time assessed daily by caregivers was averaged (i.e., average daily wear time or ADWT) for each subject for the first 90 days of treatment (excluding treatment initiation Days 1-28) and over the 12-month EPITOPE study.
Baseline markers of atopic disease
severity such as peanut-specific IgE, skin prick test wheal size, SCORAD scores (measure of atopic dermatitis) and eliciting dose were similar between subjects with ADWT 20 hours/day and < 20 hours/day. The incidence rates and severity of
local application site reactions and use of corticosteroids were also similar between groups, but the participants with ADWT < 20 hours reported markedly more scratching as a reason for patch detachments. This strongly suggests that these
participants experienced lower tolerability (i.e., higher degree of itchiness ) to peanut-induced local skin immune responses.
Data suggests that subjects with low
day-to-day wear time variability ( 20 hours/day ADWT) had a more robust efficacy response relative to the high day-to-day variability (<20 hour/day ADWT) subjects.
Efficacy and safety data were compared for VP250
participants according to ADWT.
Key data highlights include:
Average daily wear time is something that can easily be reported by my caregivers and patients and can be
a very useful tool for me to guide shared decision making. Knowing that the ADWT during the first 90 days on treatment is highly predictive of ADWT over a full year and that these data further suggest that ADWT greater than 20 hours show a strong
correlation with clinical efficacy response at 12 months will help to guide optimal use of VIASKIN peanut, if approved. , stated Dr. Edwin Kim, Division Chief, Pediatric Allergy & Immunology, University of North Carolina
School of Medicine, and presenting author.
Eastern Food Allergy and Comorbidity Conference - Poster Presentations
January 9-12, 2025, Palm Beach, FL
All posters will be displayed from 3:00pm ET on Thursday, January 9th through 11:45am ET on Saturday,
EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic
Toddlers: Results After 3 Years of Treatment
VP250 Average Daily Wear Time: Impact on Efficacy and Safety in the Phase 3 EPITOPE Study
Changes in Biomarkers During Epicutaneous Immunotherapy for Peanut Allergy in Toddlers
We are very pleased with the progress that DBV continues to make advancing this novel therapy through its remaining regulatory steps, and believe
that, if approved, it has the potential to revolutionize the treatment of peanut allergy, stated Eleanor Garrow-Holding, CEO, Food Allergy and Anaphylaxis Connection Team. It is encouraging to see new data that further
inform the real-world use of VIASKIN Peanut, and we are hopeful that it will soon be an available treatment option for peanut allergic patients and their caregivers.
Investor Conference Call and Webcast
host an investor conference call and webcast today, January 8th, at 5:00pm EST, to discuss these clinical updates. 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 a
clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening
anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT ), the
VIASKIN patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of
non-invasive treatment that seeks to modify an individual s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging
the skin s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3
years of age) and children (4 through 7 years of age).
DBV Technologies is headquartered in Ch tillon, France, with North American operations in
Warren, 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 five ordinary shares) are traded on the Nasdaq Capital Market (Ticker:
DBVT; CUSIP: 23306J309).
For more information, please visit www.dbv-technologies.com and engage with us on
X (formerly Twitter) and LinkedIn.
Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of VIASKIN Peanut patch and EPIT , designs of DBV s anticipated clinical trials, DBV s planned regulatory and clinical efforts including
timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the
confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the
BLA submission, DBV s expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, 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 projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and
DBV s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in
this press release can be found in DBV s regulatory filings with the French Autorit des March s Financiers ( AMF ), DBV s filings and reports with the U.S. Securities and Exchange Commission ( SEC ),
including in DBV s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. 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 is a registered trademark and EPIT is a trademark of DBV Technologies.