Montrouge, France, September 7, 2022
DBV
Technologies Announces
Initiation of Phase 3 Study
(VITESSE) Using
the Modified Viaskin
Peanut Patch in
Peanut -Allergic Children Ages
4 to 7 Years
- DBV has
finalized the VITESSE protocol after productive
exchanges with the U.S. Food and Drug Administration (FDA)
concerning key study design
elements
- DBV expects to screen the
first patient in Q4 2022 and
anticipates topline results for
the VITESSE study to
read out
in Q1 2025
- The VITESSE protocol has
been submitted to study sites for subsequent Institutional Review
Board (IRB)/Ethics Committee (EC) approval
- The Company will host a
conference call at 5:30
p.m.
ET (11:30
p.m.
CEST) on Wednesday, September 7,
2022
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced the initiation of the
Phase 3 study, VITESSE (Viaskin Peanut
Immunotherapy Trial to
Evaluate Safety,
Simplicity and Efficacy), using
the modified Viaskin™ Peanut Patch, in peanut-allergic children
ages 4 to 7 years. The study was initiated following productive
exchanges with the U.S. Food and Drug Administration (FDA). The
protocol has been submitted to study sites for subsequent
Institutional Review Boards (IRB)/Ethics Committees (EC)
approval.
DBV expects to enroll 600 subjects for
participation in the VITESSE study, randomized 2:1 active to
placebo. The first patient screened is expected in Q4 2022 with the
last patient screened by year-end 2023. The Company anticipates
that the topline results will read out in Q1 2025. Dr. David
Fleischer, Colorado Children’s Hospital, will act as the Principal
Investigator for the VITESSE study, which will involve
approximately 80 study sites across the U.S., Canada, Australia,
Europe and the U.K.
Over the last several months, DBV and the FDA
have engaged in ongoing discussions on the epicutaneous
immunotherapy (EPIT™) platform as a novel drug -device combination
for delivering allergen immunotherapy and on the VITESSE trial
design. These interactions determined that VITESSE will evaluate
the efficacy and safety of the modified Viaskin Peanut patch as a
peanut allergen immunotherapy, which may potentially support a
future BLA submission.
Following productive discussions, the FDA
granted DBV a Type C meeting in May 2022 to align on the VITESSE
study. The study protocol was submitted to the FDA as part of the
Type C briefing materials. Subsequent exchanges between DBV and the
FDA ensued to align on critical design elements and endpoints, and
these were included in the final protocol that was sent to study
sites.
“We are pleased to have initiated the VITESSE
study,” said Daniel Tassé, Chief Executive Officer of DBV
Technologies. “DBV has engaged in a highly collaborative process
with the FDA over the last several months, and we are proud of the
final protocol that has been shared with study sites. As I’ve said
before, VITESSE means ‘speed’ in French, and we continue to believe
that this approach is the fastest way to bring Viaskin Peanut to
peanut-allergic children in this age group. Our future patients are
counting on us, and we will continue to actively work towards
bringing this novel, innovative therapy to the market.”
VITESSE is a Phase 3, double-blind,
placebo-controlled, randomized study to assess the efficacy and
safety of epicutaneous immunotherapy with the modified Viaskin
Peanut 250 µg patch in peanut-allergic children ages 4 to 7 years.
The primary efficacy endpoint is the percentage of treatment
responders in the active versus placebo arms at month 12. The
primary efficacy analysis includes the success criterion of the
lower bound of the confidence interval of the difference in
responder rates between active and placebo groups being greater
than or equal to 15%.
DBV defined the VITESSE inclusion criteria to
address the high unmet need of younger, more sensitive peanut
allergy patients. In food allergy market research and quality
of life studies, caregivers report being highly motivated to
protect their child from a reaction to an accidental allergen
ingestion and prevent food allergy from negatively impacting their
child’s quality of life. Caregivers cite stressors specific to
younger age groups, such as a child’s inability to self-manage
their food allergy, transitions to more independent environments
such as daycare and school, and a perception that food allergy will
increasingly impact their child’s quality of life.
The decision to target the 4 to 7-year-old age
group reflects careful review of post-hoc analyses of PEPITES
(Peanut EPIT
Efficacy and Safety) efficacy
data in peanut-allergic children ages 4 to 11 years, and
consideration of the recently announced EPITOPE
(EPIT in TOddlers with
PEanut Allergy) data in toddlers ages 1 to 3
years. The VITESSE age inclusion criterion aligns the protocol with
an age cohort of peanut allergy patients who have demonstrated a
higher response rate in previous peanut allergy treatment
studies.
“We look forward to maintaining our work with
the FDA, site investigators and other key stakeholders as we
advance VITESSE,” said Dr. Pharis Mohideen, Chief Medical Officer
of DBV Technologies. “We feel confident that the VITESSE protocol
incorporates all key learnings from our previous Viaskin Peanut
studies and advances in the food allergy treatment landscape. We
believe that caregivers are motivated to seek treatment options in
this patient population.”
A treatment responder is defined as either a
subject with a baseline eliciting dose (ED) ≤30 mg who reaches an
ED ≥300 mg of peanut protein at month 12, or a subject with a
baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at
month 12. A double-blind, placebo-controlled food challenge
(DBPCFC) will be administered at baseline and month 12 to determine
a subject’s ED at both timepoints. DBV defined the peanut protein
sensitivity inclusion criteria to align with peanut allergy
patients at the greatest risk of experiencing reactions to
accidental peanut ingestion and with the highest unmet need. DBV
added a 600 mg dose of peanut protein to the month 12 DBPCFC to
increase the sensitivity of the efficacy assessment.
While adhesion of the modified Viaskin Peanut
patch will be assessed in VITESSE, there is no patch detachment
endpoint included in the study parameters. In VITESSE, adhesion
will be assessed to affirm the modified Viaskin Peanut patch
provides adequate delivery of the allergen to the immune system
over the course of 12 months. These data will be used to support
the Sponsor-defined essential device requirement as per FDA device
regulations for optimal product performance. Accordingly, the
Instructions for Use (IFU) for the modified patch will direct
caregivers to apply one patch at approximately the same time each
day, following removal of the previous day’s patch. The IFU
outlines that Viaskin Peanut 250 µg is to be worn for as close to a
full day as possible with a minimum daily wear time of at least 12
hours each day.
Participants will apply the modified patch
(either Viaskin Peanut 250 µg or a placebo) daily for a period of
12 months. The maximum study duration per subject is 58 weeks: a
four-week screening period, a 12-month treatment period and a
two-week follow-up period. During the screening period, subjects
will undergo an initial screening visit with assessment for
eligibility according to peanut skin prick test (SPT) and serum
peanut IgE. Those meeting these criteria will proceed to a peanut
DBPCFC to confirm their peanut allergy and establish an entry
peanut ED. The entry DBPCFC will be 1 mg peanut protein, and will
escalate up to a highest single dose of 100 mg peanut protein.
Subjects who react with an ED at or below the dose of 100 mg peanut
protein are considered eligible. At month 12, a post-treatment
DBPCFC will be performed, with a starting dose of 3 mg peanut
protein, escalating to a highest dose of 1,000 mg peanut protein
according to the following schedule: 3, 10, 30, 100, 300, 600,
1,000 mg. Secondary efficacy endpoints include changes in
Cumulative Reactive Dose, ED and severity of allergic reaction at
baseline and month 12 food challenge. VITESSE will also evaluate
the safety of the modified Viaskin Peanut patch based on overall
adverse events, local site reactions and systemic allergic
reactions.
DBV will host a conference call and live audio
webcast to discuss the VITESSE study on Wednesday, September 7,
2022, at 5:30 p.m. ET. This call is accessible via the below
teleconferencing numbers, followed by the reference ID:
24076524#
- United States :
866 374 5140
- Canada :
866 455 3403
- United Kingdom :
808 238 9813
- France : 805 102 712
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 the Viaskin Peanut Patch
DesignIn August 2020, DBV Technologies
received a Complete Response Letter (CRL) in connection with its
Biologics License Application (BLA) for Viaskin™ Peanut (DBV712 250
µg), an investigational, non-invasive, once-daily epicutaneous
patch to treat peanut allergy in children ages 4 to 11 years.
Subsequently, DBV proposed a potential resolution to a main concern
identified by the FDA in the CRL: the need for patch modifications.
The FDA agreed with DBV's position that a modified Viaskin Peanut
patch would be an appropriate approach and should not be considered
as a new product entity provided the occlusion chamber of the
current Viaskin Peanut patch and the peanut protein dose of 250 µg
(approximately 1/1000 of one peanut) remained unchanged and
performed in the same way they had previously. In Q4 2021, DBV
informed the FDA of its intent to initiate a pivotal Phase 3
clinical study for a modified Viaskin Peanut patch in the intended
age population. This pivotal Phase 3 clinical study, called
VITESSE, features the modified Viaskin Peanut (mVP) patch. As DBV
has previously disclosed, the mVP patch is circular in shape and
approximately 50% larger than the current Viaskin Peanut (cVP)
patch. Importantly, the EPITOPE study featured the cVP patch, which
is square in shape. DBV may maintain use of the cVP patch for
future regulatory or BLA advancements using the EPITOPE data. DBV
will use the mVP patch for the VITESSE study.
About DBV TechnologiesDBV
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
StatementsThis press release may contain forward-looking
statements and estimates, including statements regarding the
therapeutic potential of Viaskin™ Peanut as a treatment for
peanut-allergic children, the potential benefits of EPIT™, DBV
Technologies’ clinical development and regulatory plans, timing and
projections of VITESSE study milestones, and timing and anticipated
results of interactions with regulatory agencies. All statements
about VITESSE study milestones, enrollment and anticipated results
contained herein are DBV’s best estimates and projections are based
on performance of previous studies, and are subject to known and
unknown risks, uncertainties and other factors that may cause
actual results, performance and achievements with respect to the
VITESSE study to differ materially from the estimates and
projections contained herein. These forward-looking statements and
estimates are not promises or guarantees and involve substantial
risks and uncertainties and may be impacted by market conditions as
well as other risks and uncertainties set forth in DBV
Technologies’ regulatory filings with the Autorité des Marchés
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.
Investor Contact Anne PollakDBV
Technologies+1 857-529-2363anne.pollak@dbv-technologies.com
Media Contact Angela
MarcucciDBV
Technologies+1 646-842-2393angela.marcucci@dbv-technologies.com
Viaskin and EPIT are trademarks of DBV Technologies.
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