Châtillon, France, February 25, 2025
DBV Technologies to Participate in
Upcoming AAAAI/WAO Joint Congress
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced that the company will
participate in the American Academy of Allergy, Asthma, and
Immunology and World Allergy Organization (AAAAI/WAO) Joint
Congress, February 28-March 3, 2025, in San Diego, CA.
An oral abstract presentation by Dr. David
Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children’s
Hospital Colorado, will describe Month 60 (M60), end-of-study
efficacy and safety results from PEOPLE (the open-label extension
of the 12-month, double-blind placebo-controlled, Phase 3 PEPITES
study in peanut allergic children aged 4-11 years). All eligible
participants who enrolled in PEOPLE were treated with VIASKIN®
peanut patch for up to 60 months. Highlights from the presentation
include:
- Among PEOPLE participants, the
percentage of treatment responders (per PEPITES criteria) increased
from 39.1% at PEPITES completion to 52.9% at M36 to 73.3% at M60
(versus 88% at M60 among PEOPLE participants who completed the
double-blind, placebo-controlled food challenge [DBPCFC] at
M60).
- Participants achieving an eliciting
dose (ED) ≥1000 mg of peanut protein (the equivalent of 3-4 peanut
kernels) increased from 33.3% at PEPITES completion to 48.3% at M36
to 66.7% at M60 (versus 80% at M60 among participants who completed
the DBPCFC at M60).
- Similarly, participants achieving
an ED ≥2000 mg of peanut protein (the equivalent of 6-8 peanut
kernels) increased from 2.3% at PEPITES completion to 16.1% at M36
to 33.3% at M60 (versus 40.0% at M60 among participants who
completed the DBPCFC at M60).
- Most TEAEs were mild to moderate
local skin reactions and decreased in frequency and severity over
time.
- Overall mean treatment compliance
at five years remained high at 93.1%.
Dr. Fleischer will also deliver a presentation
on epicutaneous immunotherapy with the VIASKIN peanut patch and its
clinical profile at the American Association of Allergists and
Immunologists of Indian Origin (AAAII) Semi-Annual
Meeting and Symposium, February 28, 2025, in San Diego, CA. The
presentation will describe the immunological properties of the skin
as a potent route for food allergen desensitization.
Professors Hugh Sampson, MD, of the Icahn School
of Medicine at Mount Sinai (New York, NY), Helen Brough, MBBS, PhD,
of Guy's and St Thomas' NHS Foundation Trust (London, UK), and
moderator Douglas Mack, MSc, MD, of McMaster University (Ontario,
Canada), will discuss key attributes of epicutaneous immunotherapy
resulting from the skin’s unique capabilities, including controlled
allergen delivery, reduced systemic exposure risk, and
non-invasive, simple administration, at DBV’s non-CME Product
Theater titled, “From Trigger to Tolerance: Harnessing the Skin’s
Dual role with Epicutaneous Immunotherapy”. The Product Theater is
scheduled for Saturday, March 1, from 10:00 a.m. to 10:30 a.m. PST
in the San Diego Convention Center, Exhibit Hall A.
DBV will host a booth (#1740) in the AAAAI/WAO
Joint Congress exhibit hall where attendees can learn more about
epicutaneous immunotherapy with the VIASKIN® peanut patch,
including the company’s ongoing and planned clinical trials in
peanut-allergic children.
“The compelling five-year results from the
PEPITES open label extension that are being presented at this
year’s AAAAI/WAO Joint Congress help to further characterize the
long-term efficacy and safety of the VIASKIN® peanut patch and add
to the growing body of evidence, which demonstrates its potential
as a breakthrough treatment for children suffering from peanut
allergy if approved,” stated Pharis Mohideen, Chief Medical
Officer of DBV. “Perhaps most notably from the PEOPLE
data, treatment benefit continued to accumulate over time, with
approximately 2/3 of study subjects reaching an ED of 1,000 mg or
more of peanut protein, approximately equivalent to 3-4 peanut
kernels, at Month 60, while the incidence of adverse events – most
of which were mild-to-moderate local skin reactions – decreased in
frequency and severity over that same time period.”
“The fact that treatment compliance exceeded 93%
at five years gives us confidence in VIASKIN® peanut patch’s
ability to become a practical new treatment option in peanut
allergy upon approval. To that end, we are committed to efficiently
completing the remaining studies in support of two distinct
regulatory submissions – one in toddlers aged 1-3 years, and one in
children aged 4-7 years,” concluded Dr.
Mohideen.
DBV Presentation Details:
Oral Abstract Presentation at the AAAAI/WAO 2025
Joint Congress
“Long-Term Efficacy Results of
Epicutaneous Immunotherapy With VIASKIN®
Peanut Patch in Peanut-Allergic Children Aged 4-11 Years in
the Phase 3 PEOPLE Study” will be presented by Dr. David
Fleischer.
- Session: 4605 - Latest on Treatment
Outcomes in Food Allergy and Eosinophilic Esophagitis
- Presentation date: March 3
- Presentation time: 1:30-1:40pm
PST
- Presentation location: San Diego
Convention Center, Upper Level, Room 11B
Presentation at the American Association of
Allergists and Immunologists of Indian Origin (AAAII) Semi-Annual
Meeting and Symposium
"Understanding the Skin as a Potent
Route for Food Allergen Desensitization" will be
presented by Dr. David Fleischer.
- Presentation date: February 28
- Presentation time: 7:00-7:30pm
PST
- Presentation location: San Diego
Marriott Marquis Marina, Room Marina E
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 the
submission of BLAs to FDA, anticipated support for the BLA
submission, , 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
DBV Technologies (EU:DBV)
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