DBV Technologies Announces New England Journal of Medicine
Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin™
Peanut in Toddlers
Montrouge, France, May 10, 2023
DBV Technologies
Announces New England Journal
of Medicine Publication of
Phase 3 EPITOPE Trial
Data
Evaluating Viaskin™ Peanut in
Toddlers
-
The New England Journal
of Medicine (NEJM) published results that
demonstrated epicutaneous immunotherapy
(EPITTM) with Viaskin
Peanut was statistically
superior to placebo in desensitizing children to
peanut by increasing the peanut
dose that triggers allergic
symptoms.
- As stated in an
accompanying editorial piece, these data
are seen as
“very good
news” for toddlers with peanut
allergy, as there are currently no
approved treatment options for
peanut-allergic children under the age of 4 years.
- DBV is advancing
regulatory efforts for Viaskin Peanut in
toddlers ages 1 – 3 years old with a confirmed peanut
allergy.
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced that its Phase 3 EPITOPE
trial of epicutaneous immunotherapy (EPIT) with Viaskin™ Peanut in
children 1 – 3 years was published in the New England Journal of
Medicine, reinforcing the potential of a new food allergy treatment
option for this community.
“We are thrilled to see the EPITOPE Phase 3 data
published in the New England Journal of Medicine, highlighting
exciting results for toddlers with peanut allergy and their loved
ones,” said Daniel Tassé, Chief Executive Officer
of DBV Technologies. “This publication comes
shortly after receiving pre-BLA feedback from the FDA, which
outlined the regulatory path for our Viaskin Peanut program in 1 –
3-year-olds. Parents and caregivers are eagerly awaiting
FDA-approved treatment options for this age group. We are pleased
that the NEJM has confirmed what we know to be true: the EPITOPE
data represent a ‘next step towards a future with more [approved]
treatments for food allergies.’.”1
Peanut allergy is the most common food allergy
in children in the United States, with growing prevalence and
increasing impact on patients, families, and health systems.
Despite this substantial burden, there are limited treatment
options for peanut allergy and no FDA approved options for children
younger than 4 years of age.
Viaskin Peanut, a novel form of EPIT, has the
potential to offer a new and breakthrough science that modifies an
individual’s underlying food allergy by re-educating the immune
system to increase tolerance to allergens. As stated in the article
“the developing immune system may be particularly amenable to
desensitization, which provides an important rationale for
prioritizing treatments that target younger children.”
The NEJM highlights that EPIT with Viaskin
Peanut, as a patch-based nonoral immunotherapy option, has shown in
clinical studies consistent evidence of efficacy, safety, and high
treatment adherence. The EPITOPE trial was designed to allow
participants to go about their normal daily activities such as
playing, showering, or swimming, without restrictions.
“I see peanut-allergic patients in my clinical
practice daily. I speak with parents who are experiencing increased
anxiety and a decreased quality of life due to fear of
life-threatening reactions,” said Matthew Greenhawt, M.D.,
MBA, MSc of Children’s Hospital Colorado
and lead author of the publication. “This publication shows that,
if approved, the Viaskin Peanut patch has the potential to give new
hope to toddlers and their families who currently have no approved
treatment options and must instead rely on avoidance, which can
severely impact quality of life. The EPITOPE data are a meaningful
advancement in potentially offering the first-ever FDA approved
treatment option for peanut-allergic toddlers.”
EPITOPE was a Phase 3, randomized, double-blind,
placebo-controlled trial to assess the efficacy and safety of
Viaskin Peanut in children 1 through 3 years of age with a
diagnosed peanut allergy.
After one year of treatment, Viaskin Peanut
resulted in statistically superior desensitization compared with
placebo, with treatment responder rates of 67.0% and 33.5%,
respectively. Additionally, a shift towards less severe food
challenge reactions was seen following 12 months of treatment with
Viaskin Peanut. Similar to previous studies of Viaskin Peanut in
children, the most common adverse events were local application
site reactions, which decreased in frequency and severity over
time. Low rates of treatment-related anaphylaxis and epinephrine
use were observed. This study demonstrated that 12 months of daily
EPIT with a patch containing 250 µg peanut protein (1/1000th of one
peanut) resulted in greater desensitization compared with placebo,
sufficient to decrease the likelihood of experiencing an allergic
reaction following accidental peanut exposure.
Viaskin Peanut was well-tolerated by a majority
of participants and had low discontinuations due to AEs and high
compliance rates. Subjects were able to wear the patch daily
without restrictions around activities for a sufficient duration
over the course of the treatment period to induce
desensitization.
“As a parent who has raised children with food
allergies and as a voice for the food allergy community, I am
encouraged to see the EPITOPE trial results published by the New
England Journal of Medicine,” said
Kenneth Mendez, CEO of
the Asthma and Allergy Foundation of America and its food
allergy division, Kids with Food Allergies. “Many
caregivers worry about their food-allergic toddler’s accidental
exposure to a food allergen. This sometimes means that they will
limit their toddler from everyday activities. Caregivers need a
treatment option that provides peace of mind for them and for their
children. I am excited by this innovative potential treatment
option and hopeful that one day, toddlers with peanut allergy will
have multiple treatment options to choose from.”
To view the full publication, accompanying
QuickTake video, and editorial from the NEJM please visit the
following:
Phase 3 Trial of Epicutaneous Immunotherapy in
Toddlers with Peanut Allergy
NEJM QuickTake
Good News for Toddlers with Peanut Allergy
About EPITOPEEPITOPE
(NCT03211247) enrolled 413 subjects (51 in Part A and 362 in Part
B) in approximately 50 centers across North America (Canada and the
United States), Europe and Australia. The EPITOPE trial was a
two-part trial: Part A was designed to assess the safety of Viaskin
Peanut 100 µg and 250 µg and to determine the highest safe dose,
and Part B was designed to assess the efficacy and safety of the
selected dose. Based on the results of Part A, the 250 µg dose was
selected for Part B. In Part B, subjects were randomized 2:1 to
receive Viaskin Peanut 250 µg or placebo.
The primary endpoint was based on a responder
analysis after 12 months of treatment with the selected dose of
Viaskin Peanut. As a secondary efficacy endpoint, cumulative
reactive dose (CRD) was also evaluated in EPITOPE to establish the
total quantity of peanut protein that triggers subject reactions at
month 12 of active treatment versus placebo. Serological markers
were also measured at baseline, 3, 6 and 12 months in order to
characterize the immunological changes in subjects. There were no
limitations on activities of daily living in this trial.
Participants were able to go about their normal lives without
restrictions, including playing, showering, or swimming.
Following the completion of EPITOPE, all
eligible subjects had the option to rollover into EPOPEX, a
long-term, open-label extension study of Viaskin Peanut 250 µg. Now
that the EPITOPE study results are publicly available, subjects
enrolled in the EPOPEX study will be unblinded to their respective
treatment group in EPITOPE.
In June 2022, DBV Technologies announced
positive topline results from EPITOPE. Viaskin Peanut demonstrated
a statistically significant treatment effect (p<0.001), with
67.0% of subjects in the Viaskin Peanut arm meeting the treatment
responder criteria after 12 months, as compared to 33.5% of
subjects in the placebo arm (difference in response rates = 33.4%;
95% CI = 22.4% - 44.5%). The EPITOPE safety results were generally
consistent with the safety profile of Viaskin Peanut 250 μg
observed in children with peanut allergy ages 4 years and older in
prior clinical trials. No imbalance in the overall adverse event
(AE) rate was observed in the trial between the active and placebo
arms. For more information on the EPITOPE results see the DBV press
release.
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 contains forward-looking statements and estimates,
including statements regarding DBV Technologies’ clinical
development and regulatory plans with respect to Viaskin™ Peanut
for the treatment of toddlers ages 1-3 years old, the therapeutic
potential of Viaskin™ Peanut as a treatment for peanut-allergic
children more broadly, the ability of any of the Company’s product
candidates, if approved, to improve the lives of patients with food
allergies, designs of the Company’s anticipated clinical trials,
safety studies and HF studies, and the timing and anticipated
results of interactions with regulatory agencies. These
forward-looking statements and estimates are not promises or
guarantees and involve substantial risks and uncertainties,
including risks inherent to the clinical development and regulatory
process, as well as market conditions and 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 Katie
MatthewsDBV
Technologies+1 857-529-2563katie.matthews@dbv-technologies.com
Media Contact Angela
MarcucciDBV Technologies+1
646-842-2393angela.marcucci@dbv-technologies.com
Viaskin and EPIT are trademarks of DBV
Technologies.
1 Togias, Alkis, M.D., “Good News for Toddlers
with Peanut Allergy.” New England Journal of Medicine. 388;19. May
11, 2023.
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