Châtillon, France, December 11th, 2024
DBV Confirms Alignment with U.S. FDA on
Accelerated Approval Pathway for the Viaskin® Peanut Patch in
Toddlers 1 – 3 Years-Old
- DBV and FDA aligned on key
study design elements for the COMFORT Toddlers study in 1 – 3
year-olds, including study size and wear time collection
methodology and analysis
- COMFORT Toddlers study
on-track to initiate in 2Q 2025
- Viaskin Peanut patch BLA
submission for the Toddlers indication anticipated for 2H
2026
- FDA confirmed criteria for
post-marketing confirmatory study in toddlers 1 – 3
years-old
- 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 the successful outcome
of recent written and oral communication with the U.S. Food and
Drug Administration (FDA) that provides a clear and well-defined
regulatory pathway for the Viaskin Peanut patch program in toddlers
1 – 3-years-old. The FDA has formalized guidance on an Accelerated
Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old.
DBV and FDA have agreed on the key design elements for a
post-marketing confirmatory study.
“DBV is pleased to have received, what we
believe to be, a clear and reasonable pathway towards an
Accelerated Approval for the Viaskin Peanut patch in toddlers 1 –
3-years-old. This comes on the heels of our October 22nd press
release announcing details in support of our separate Viaskin
Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in
Europe,” said Daniel Tassé, Chief Executive Officer, DBV
Technologies. “We believe we have decreased the regulatory
pathway risk of our programs. DBV can now fully focus on executing
the remaining studies that will support two distinct BLAs across
age groups and an MAA in Europe. We are grateful to the Agency for
its attentive collaboration as we continue to work towards
introducing this novel therapy to caregivers and patients as
expeditiously as possible.”
Accelerated Approval Pathway
The FDA recently issued written communication confirming an
Accelerated Approval pathway for the Viaskin Peanut patch in
toddlers 1 – 3-years-old. As a reminder, current FDA guidance for
Accelerated Approval includes three qualifying criteria:
- That the product candidate treats a
serious condition
- That the product candidate
generally provides a meaningful advantage over available
therapies
- That the product candidate
demonstrates an effect or an intermediate clinical endpoint that is
reasonably likely to predict clinical benefit
As DBV previously announced, FDA confirmed via
written communication that the Viaskin Peanut patch already met
criteria one and two.
FDA and DBV have been engaged in ongoing
dialogue throughout Q4 of this year regarding the intermediate
clinical endpoint necessary to meet the third criterion. In the
recent written communication, the FDA confirmed the efficacy data
from the Company’s Phase 3 EPITOPE study can serve as an
intermediate clinical endpoint. The FDA has agreed that the
endpoint is reasonably likely to predict clinical benefit and will
therefore fulfill the requirement for Accelerated Approval.
In preparation for commercialization, DBV made
slight modifications to the Viaskin Peanut patch used in EPITOPE to
increase the simplicity of application for the caregiver and
provide product identification on each patch. No
changes, including patch shape or size, were made to the device
components that are in contact with the patient’s skin. Further, to
increase the volume of patch production for future
commercialization, changes needed to be made to the manufacturing
process and location.
Although the intended commercial Viaskin Peanut
patch is currently being used (N=304) in the ongoing 3-year Open
Label Extension to EPITOPE, the collective changes to the
commercial Viaskin Peanut patch were viewed by the FDA as
constituting a different product relative to the clinical patch
used in the EPITOPE study. The Company intends to use the
commercial Viaskin Peanut patch in both the COMFORT Toddlers study
and the post-marketing confirmatory study.
Post-Marketing Confirmatory
Study In the recent written communication, FDA confirmed
criteria for a post-marketing confirmatory study in toddlers 1 –
3-years-old. DBV and FDA agreed that the confirmatory study will
assess the effectiveness of the intended commercial Viaskin Peanut
patch and will need to be initiated at the time that the BLA is
submitted.
To date, the commercial patch has been used in
304 subjects with over 234,695 patient-days of therapy in the
placebo crossover and the EPITOPE Open Label Extension, with no
clinically relevant differences in efficacy or safety vs. the
clinical patch used in the EPITOPE Phase 3 trial.
The confirmatory study will include a
double-blind, placebo-controlled food challenge (DBPCFC) and will
use the same statistical criteria for success (i.e., lower bound of
the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study.
Adhesion data for the post-marketing confirmatory study will be
collected in a similar manner relative to the COMFORT Toddlers
study. The Company expects these data will further support the
importance of average daily wear time in the use of the Viaskin
Peanut patch as it relates to efficacy and labeling.
“When it comes to food allergy management, what
works for one family, might not work for another. That is why
having varied treatment options available is so incredibly
important to our community,” said Sung Poblete, PhD, RN,
CEO of FARE (Food Allergy Research & Education). “I’m
pleased to learn that DBV’s constructive dialogue with the FDA has
resulted in this Accelerated Approval guidance outlining remaining
developmental steps for the Viaskin Peanut patch in toddlers with a
peanut allergy. At FARE, we look forward to the possibility that
one day, if approved, caregivers and families will have this
exciting new treatment as an option to consider.”
COMFORT Toddlers Supplemental Safety
StudyCOMFORT Toddlers is a Phase 3 double-blind,
placebo-controlled (DBPC) study designed to generate additional
safety (primary endpoint) and adhesion data of the Viaskin Peanut
patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased
to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe
Food Allergy Institute, the Icahn school of Medicine at Mount
Sinai, will act as the Global Principal Investigator for the
COMFORT Toddlers study.
“I am thrilled to assume the role of Global
Principal Investigator of the COMFORT Toddlers study,” stated
Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy
Institute, Icahn school of Medicine at Mount Sinai in New
York. “Viaskin Peanut, if approved, would offer a
much-needed alternative treatment option for patients and
caregivers. I look forward to working with the DBV team to advance
this important clinical trial.”
The Company anticipates that COMFORT Toddlers
will enroll approximately 480 subjects randomized 3:1 (active:
placebo) at approximately 80 – 90 study centers across the U.S.,
Canada, Australia, and Europe. COMFORT Toddlers will be a six-month
study followed by an optional 18-month open-label treatment phase,
to provide 24 or 18 months of treatment with the Viaskin Peanut
patch for participants randomized to the active or placebo groups,
respectively. Thus, the COMFORT Toddlers study will increase the
total subjects exposed to the Viaskin Peanut patch for at least
six-months in a controlled study to 600, as required by FDA. In
total, there will be approximately 240 subjects with the clinical
patch in EPITOPE and 360 with the commercial patch in COMFORT
Toddlers.
As previously disclosed, DBV and FDA have
aligned on a patch wear time collection methodology, analysis and
study objective hierarchy in the COMFORT Toddlers study. The
agreed-upon adhesion data collection methodology provides a
practical approach for subjects, families, and investigators. The
methodology is intended to generate sufficient data to support a
BLA submission under the Accelerated Approval pathway (i.e.,
collecting patch adhesion data with a focus on daily wear time at
relevant time points). We believe there are three positive outcomes
coming out of the productive discussions with FDA:
- FDA agreed that adhesion would not
be a co-objective of a safety study and would be an exploratory
endpoint.
- Next, adhesion should be assessed
in the overall totality of benefit to risk (i.e., in the context of
efficacy and safety).
- The third success is that we have
aligned on what DBV believes is a very feasible approach to
collecting adhesion data.
DBV has initiated study start-up activities and
plans to screen the first subject in the second quarter of
2025.
Biologic License Application Submission
in 1 – 3 Year-OldsThere will be two Phase 3 studies in 1 –
3-year-olds using the Viaskin Peanut patch. The data generated from
the studies will be used to inform a BLA submission:
- Twelve months of DBPC efficacy and
safety data from the previously completed Phase 3 EPITOPE study
(published in the New England Journal of Medicine in May 2023), and
36 months of open-label extension data.
- Six months of DBPC data generated
in COMFORT Toddlers supplemental safety study.
DBV anticipates that the BLA for the Viaskin
Peanut patch in toddlers 1 – 3 years-old under the Accelerated
Approval program will be submitted in 2H 2026.
Investor Conference Call and
WebcastDBV management will host an investor conference
call and webcast today, Wednesday, December 11th, at 5:00pm EST, to
discuss these regulatory 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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