DBV Announces Positive Regulatory Updates for the Viaskin® Peanut
Patch in the United States and Europe
Châtillon, France, October 22, 2024
DBV Announces Positive Regulatory
Updates for the Viaskin® Peanut Patch in the United States and
Europe
- DBV to pursue an
Accelerated Approval pathway for toddlers ages 1 – 3
years-old
- BLA submission under
Accelerated Approval is subject to completion of a six-month
supplemental safety study in toddlers to be initiated in Q2
2025
- VITESSE Phase 3 study
evaluating the Viaskin Peanut patch in children ages 4 – 7
years-old exceeded enrollment goals; Topline results on track for
4Q 2025
- European Medicines Agency
(EMA) scientific advice confirms registration path for a Marketing
Authorization Application (MAA) with the modified Viaskin peanut
patch for a 1 – 7 year-old indication in Europe
- Company to host investor
conference call at 5:00pm ET today
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced positive regulatory
updates for the Viaskin Peanut patch in the United States and
Europe. DBV has agreed to guidance provided by the U.S. Food and
Drug Administration (FDA) on a pathway under the Accelerated
Approval Program for the Viaskin Peanut patch in toddlers ages 1 –
3 years-old and has also received scientific advice from the EMA on
a 1 – 7 year-old indication in Europe. DBV intends to formalize the
Accelerated Approval guidance provided by the FDA via submission of
a meeting request.
“Our agreement with FDA guidance on a path
towards Accelerated Approval for the Viaskin Peanut patch in 1 – 3
year-olds represents a significant step forward in getting this
novel treatment to patients,” said Daniel Tasse, Chief
Executive Officer, DBV Technologies. “I am pleased
that the FDA recognizes the urgent unmet medical need that exists
for this young patient population. We are also very pleased with
the scientific advice received from EMA – one patch in peanut
allergic children in 1 – 7 year-olds, subject to a safety study
with our modified patch in toddlers 1 – 3 years-old.”
Viaskin Peanut Patch in Toddlers 1 – 3
Years
Accelerated Approval
Pathway
FDA guidance for Accelerated Approval include three qualifying
criteria: 1) that the product treats a serious condition, 2) that
the product candidate generally provides a meaningful advantage
over available therapies, and 3) that the product candidate
demonstrates an effect on an intermediate clinical endpoint that is
reasonably likely to predict clinical benefit.
FDA confirmed that DBV has met criterion 1 and
2. Regarding criterion 3, FDA has provided guidance and suggestion
regarding the intermediate clinical endpoint, which DBV has agreed
to in informal discussions with the FDA. DBV intends to formalize
the Accelerated Approval guidance provided by FDA via submission of
a meeting request to confirm the general elements of the two study
components: the COMFORT Toddlers safety study, to be completed
before BLA submission, and the confirmatory effectiveness study,
including the third Accelerated Approval criterion regarding the
intermediate clinical endpoint. DBV expects that the confirmatory
study will be initiated by the time of BLA submission and would run
in parallel to commercialization in the United States, if Viaskin
Peanut is approved.
COMFORT Toddlers
DBV is pleased to have aligned with FDA on a wear time collection
methodology in COMFORT Toddlers that provides a practical approach
for subjects and families, is intended to generate sufficient data
to support a BLA submission, and places wear time into an
acceptable clinical hierarchy relative to other study endpoints.
DBV has initiated study start-up activities and plans to screen the
first subject in the second quarter of 2025. The company
anticipates enrolling approximately 300 - 350 subjects on active
treatment into the safety study, which would bring the total
Viaskin Peanut patch safety database in toddlers to approximately
600 subjects, consistent with prior FDA guidance.
With this path forward, the BLA submission for
Viaskin Peanut patch in 1 – 3 year-olds under the Accelerated
Approval program is anticipated to be supported by:
- Positive efficacy and safety data
from DBV’s previously completed EPITOPE Phase 3 Study; and
- Additional safety data generated in
COMFORT Toddlers supplemental safety study to be initiated in 2Q
2025.
“DBV’s Viaskin Peanut patch has the
potential to significantly improve the lives of peanut allergic
toddlers and their caregivers,” stated Dr. David
Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children’s
Hospital Colorado. “With few approved treatment
options for this patient population – the age range in which most
young people are initially diagnosed with peanut allergy – the
Viaskin Peanut patch has the potential to be a game changer in the
food allergy community, and I look forward to having the
opportunity to incorporate it into my own practice, if
approved.”
Post-Marketing Confirmatory
Study
DBV and FDA are in general agreement that the confirmatory study
will need to demonstrate the effectiveness of the Viaskin Peanut
patch and will need to be initiated at the time that the BLA is
submitted. DBV will prioritize initiation of the COMFORT Toddlers
safety study to enable the BLA submission.
“We are encouraged to learn that FDA has
heard the voices of the food allergy community,” said
Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research
and Education). “This hopeful advancement in the
treatment of peanut allergic toddlers has the potential to make a
positive impact on the millions of families that are urgently
awaiting innovative treatment options, and the confirmatory study
will certainly add to the rich data that has been compiled in this
important disease space. We stand by DBV in their efforts to
advance Viaskin and look forward to representing the patient
perspective.”
Regulatory History of the Viaskin Peanut
Patch in Toddlers 1 – 3
DBV and the FDA have been engaged in ongoing dialogue regarding the
COMFORT Toddlers supplemental safety study in 1 – 3 year-olds with
a peanut allergy. The focus of continued exchanges has been
on patch adhesion, specifically:
- The hierarchy of an adhesion
assessment within the COMFORT Toddlers study (FDA requesting that
it be a study objective vs. exploratory assessment);
- The sufficiency of adhesion data
collected during the EPITOPE study to fully characterize daily
patch adhesion duration (wear time) given the EPITOPE adhesion data
collection methodology, and, conversely, the collection methodology
required to generate sufficient adhesion data to inform the Viaskin
label in future studies; and
- The clinical relevance and
regulatory use of adhesion data collected in a study that does not
include an efficacy assessment.
DBV’s proposed labeling solution, submitted to
the FDA on June 28, 2024, became critical in exploring with the
FDA, practical solutions to linking adhesion, efficacy and safety
to best inform the label. These fruitful discussions have led to
what DBV believes to be an actionable regulatory pathway.
Viaskin Peanut Patch in Children 4 –
7
In September 2024, DBV announced that patient screening had been
completed for the Phase 3 efficacy trial of the Viaskin Peanut
patch in peanut allergic children ages 4 – 7 years-old (VITESSE). A
total of 654 subjects were enrolled, and DBV anticipates topline
data in the fourth quarter of 2025.
The COMFORT Children safety study is expected to
be initiated in the second quarter of 2025. This study plans to
enroll approximately 250 subjects to raise the total number of 4 –
7 year-olds on active treatment across the development program to
approximately 600, consistent with prior FDA guidance. These two
studies will constitute the core studies for a BLA submission in 4
– 7 year-olds.
EMA Regulatory Update
DBV sought scientific advice from the EMA regarding the components
of a MAA for the Viaskin Peanut patch. Previous advice obtained
from two local country regulatory health authorities indicated a
potential path for a 1 – 7 year-old registration with one patch,
the modified patch. The EMA recently confirmed through scientific
advice that the completed EPITOPE study in 1 – 3 year-olds, and a
positive VITESSE study in 4 – 7 year-olds, could constitute an MAA
submission for a 1 – 7 year-old indication for peanut allergy
patients using the modified patch, along with a new safety study in
1 – 3 year-olds with the modified patch. Timing for the initiation
of this new safety study to satisfy the important EU market is
currently being planned.
The most recent European Academy of Allergy
& Clinical Immunology (EAACI) draft Guidelines on the
Management of IgE-mediated Food Allergy has the following
recommendation: “In children and adolescents with IgE-mediated
peanut allergy, peanut epicutaneous immunotherapy is suggested to
achieve desensitization, if available.” This recommendation further
supports the potential clinical benefit of the Viaskin Peanut
Patch, if approved, in Europe and the unmet medical need.
Financial Update
Based upon preliminary estimates and information available to the
Company as of the date of this announcement, DBV’s cash and cash
equivalents amount to $46.4 million as of September 30, 2024,
compared to $66.2 million as of June 30, 2024, a net decrease
by $19.8 million comprising :
- $22.5 million of net cash flow used
in operating activities, mainly external clinical-related expenses
notably progress on patient enrollment in VITESSE Phase 3 clinical
trial, Regulatory and Medical activities as well as
Manufacturing Operations.
- Partially offset by Research Tax
Credit complementary refund for years 2020 to 2022 of $3.0
million.
These preliminary financial results reflect the
Company’s estimates and are based on currently available
information. The Company’s actual financial results for the quarter
ended September 30, 2024 have not yet been finalized by management
or reviewed by the Company’s independent auditors. This preliminary
financial information is not a comprehensive statement of all
financial results for the quarter ended September 30, 2024.
Accordingly, undue reliance should not be placed on these
preliminary financial results.
The Company has incurred operating losses and
negative cash flows from operations since inception. As of the date
of this announcement, the Company’s available cash and cash
equivalents is not projected to be sufficient to support its
operating plan for at least the next 12 months. As such, there is
substantial doubt regarding the Company’s ability to continue as a
going concern. Based on current operations, plans and assumptions,
the Company expects that its balance of cash and cash equivalents
will be sufficient to fund its operations into 1Q 2025 and intends
to seek additional capital as it continues research and development
efforts and prepares for the launch of Viaskin Peanut, if
approved.
Investor Conference Call and
Webcast
DBV management will host an investor conference call and webcast
today, October 22nd, 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 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 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 one ordinary share) are traded on the Nasdaq Capital
Select Market (Ticker: DBVT).
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 DBV’s financial condition
(including certain preliminary financial results), forecast of its
cash runway, 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 to formalize the
Accelerated Approval guidance provided by the FDA via submission of
a meeting request, expectations regarding initiation of the
confirmatory study, plans and expectations with respect to COMFORT
Toddlers (including DBV’s plan to prioritize initiation of this
study), anticipated support for the BLA submission, DBV’s
expectations with respect to an 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 Matthews
DBV Technologies
katie.matthews@dbv-technologies.com
Media Contact
Angela Marcucci
DBV Technologies
angela.marcucci@dbv-technologies.com
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