Châtillon, France, January 8th, 2025
DBV Technologies Announces Positive
3-Year Results from EPITOPE Phase 3 Open-Label Extension
Study
- EPITOPE OLE data
demonstrates continued improvement in treatment benefit of VIASKIN®
Peanut patch in toddlers 1 – 3 years through 36
months
- 68.2% of subjects completed
the oral food challenge (~12-14 peanut kernels) without meeting
stopping criteria, compared to 30.7% at month 12
- No treatment-related
anaphylaxis or serious treatment-related Treatment-Emergent Adverse
Events (TEAEs) occurred in year three of EPITOPE OLE
- DBV also announced daily
patch wear time data from EPITOPE that is supportive of the
Company’s proposed labeling approach shared with FDA
- DBV to highlight these data
in multiple abstract presentations at the Eastern Food Allergy
& Comorbidity Conference, January 9-12, in Palm Beach,
Florida
- Company to host investor
webcast today at 5:00pm ET
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 µg [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.
DBV also 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
ResultsAfter completing 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:
- 266 EPITOPE participants enrolled
in the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62
placebo).
- After three years of VP250, 83.5%
of participants reached an eliciting dose (ED) of ≥1000 mg, an
increase from 64.2% at month 12 (the EPITOPE study).
- A similar increase was observed for
participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0%
at month 12;).
- Those completing the DBPCFC without
meeting stopping criteria increased to 68.2% at month 36 from 30.7%
at month 12.
- Continued reductions in DBPCFC
reaction severity occurred, with 66.5% having no/mild symptoms at
month 36 vs 40.2% at month 12.
- No treatment-related anaphylaxis or
serious treatment-related TEAEs occurred in Year 3.
- Local application-site reactions
occurred less frequently in Year 3 vs Years 1 and 2.
- In placebo-treated EPITOPE
participants, outcomes after 24 months of VP250 in the OLE were
consistent with 24-month results in EPITOPE VP250
participants.
“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:
- 167/244 (68.4%) VP250 participants
had an ADWT ≥20 hours, with median ADWT (22.9 hours) similar to
placebo (23.7 hours).
- 77/244 (31.6%) participants had an
ADWT <20 hours (median: 16.7 hours).
- ADWT during the first 90 days on
treatment was highly predictive of ADWT over the 12-month treatment
period (r=0.81).
- Participants with ADWT ≥20 vs
<20 hours during the first 90 days showed greater month 12
efficacy, according to EPITOPE responder criteria (75.7% vs
47.3%).
- Rates of key safety outcomes of
interest were numerically lower in participants with ADWT ≥20 vs
<20 hours, based on treatment-related: epinephrine use (0.6% vs
2.6%), anaphylaxis (0.6% vs 3.9%), and permanent discontinuations
(9.6% vs 19.5%).
- As a point of reference, overall
clinical response in EPITOPE was 67.0% for patients on active, and
33.5% for patients on placebo.
“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 PresentationsJanuary 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, January
11th.
“EPOPEX, Efficacy and Safety of
Epicutaneous Immunotherapy in Peanut-allergic Toddlers: Results
After 3 Years of Treatment”
- Presenter: Matthew Greenhawt,
MD
“VP250 Average Daily Wear Time: Impact
on Efficacy and Safety in the Phase 3 EPITOPE Study”
- Presenter: Edwin H. Kim, MD
“Changes in Biomarkers During
Epicutaneous Immunotherapy for Peanut Allergy in
Toddlers”
- Presenter: Edwin H. Kim, MD
“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
WebcastDBV management will 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.
- United States: +1-877-346-6112
- International: +1-848-280-6350
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 TechnologiesDBV
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 Châtillon,
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 StatementsThis
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 Autorité des Marchés 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.
Investor Contact Katie
MatthewsDBV Technologieskatie.matthews@dbv-technologies.com
Media ContactAngela MarcucciDBV
Technologiesangela.marcucci@dbv-technologies.com
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