Montrouge, France, June 8, 2023
DBV Technologies to
Participate in Upcoming EAACI Congress
2023
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced upcoming participation
in the European Academy of Allergy and Clinical Immunology (EAACI)
Congress, June 9 – 11, 2023, in Hamburg, Germany. DBV will present
three posters and will also host a symposium and exhibit booth in
the EAACI exhibit hall.
Data to be presented during the scientific
sessions will describe the current burden of peanut allergy and
treatment management strategies for children in the U.K. DBV will
also present data from its completed EPITOPE Phase 3 study
assessing the efficacy and safety of epicutaneous immunotherapy
(EPIT) using Viaskin Peanut™ in toddlers aged 1-3 years with or
without concomitant asthma. The toddler age-group represents the
age range in which many peanut-allergic children are diagnosed, yet
there are currently no approved therapies for this patient
population.
“We know that there is an urgent unmet need for
treatment options in toddlers living with a peanut allergy, and
that no FDA or EMA approved therapies currently exist for those
under the age of four years old,” said Daniel Tasse, Chief
Executive Officer, DBV Technologies. “That is why we are working
hard to advance our science for this patient population and are
pleased to have a significant presence at EAACI again this year to
share our progress and participate in academic discussions with the
many global allergy and immunology thought leaders who will be in
attendance.”
DBV’s symposium, “Addressing the Burden of
Patients Living with Peanut Allergy”, will be co-chaired by
Stefania Arasi, MD, PhD, MSc, Pediatric Allergist & Researcher
at Paediatric Allergy Unit, Bambino Gesù Children Research Hospital
(IRCCS) in Rome, EAACI Pediatric Section Chair and Susanne Lau, MD,
PhD, Deputy Head of Pediatric Respiratory Medicine, Immunology and
Critical Care Medicine Department, Charité Medical University of
Berlin. It will include lectures by Sabine Schnadt, of the German
Allergy and Asthma Association, Mönchengladbach, Germany, on the
value of thresholds of reaction and Dr. George du Toit, of King’s
College London, on data from the Company’s Phase 3 EPITOPE study,
respectively.
“We look forward to presenting the EPITOPE Phase
3 data at EAACI this year. The development of a well-tolerated and
convenient treatment option continues to be a primary focus for
DBV, and we believe the data to be presented will show our ongoing
commitment and efforts to progress the development of this
potential treatment option for underserved patients,” said Dr.
Pharis Mohideen, Chief Medical Officer, DBV Technologies. “Our
symposium will address a theme that peanut-allergy caregivers know
well: the burdens that patients face in living with their
condition. As a food allergy parent, I believe it is critical that
we continue to engage in this open dialogue on how we can help
improve lives for patients and families in a meaningful way.”
Symposium
“Addressing the
Burden of
Patients
Living with
Peanut
Allergy” will be chaired by Dr.
Stefania Arasi and Dr. Susanne Lau
- Date and location: Saturday, 10
June, 12:00 – 13:00 CEST, Hall E
- Lectures:
-
“Introduction,"
Dr. Stefania Arasi
- “Managing
the risk of patients with peanut allergy: the value of thresholds
of reaction,” Dr. Sabine Schnadt
-
“Epicutaneous Immunotherapy for peanut
allergy: an update,” Dr. George du
Toit
-
“Conclusion,”
Susanne Lau
Scientific Presentations
“Characteristics and
current management strategies of children diagnosed with peanut
allergy (PA) in the United Kingdom
(UK)”
- Session title: Food allergy 1
- Session date and time: Friday, 9
June, 2023, 12:00 – 13:00 CEST
“Health state utilities
in children with peanut allergy and their parents: a UK vignette
study”
- Session title: Food allergy 2
- Session date and time: Saturday, 10
June, 2023, 12:00 – 13:00 CEST
“Efficacy and Safety of Epicutaneous
Immunotherapy (EPIT) for Peanut Allergy in Subjects Aged 1-3
Years With and Without
Concomitant Asthma in the EPITOPE Study”
- Session title: Asthma 3
- Session date and time: Sunday, 11
June, 2023, 12:45 – 13:45 CEST
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
ContactKatie MatthewsDBV Technologies+1
857-529-2563katie.matthews@dbv-technologies.com
Media ContactAngela MarcucciDBV
Technologies+1 646-842-2393angela.marcucci@dbv-technologies.com
Viaskin and EPIT are trademarks of DBV
Technologies.
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