DBV Technologies Initiates Phase III Study of Viaskin Peanut in Peanut-Allergic Patients One to Three Years of Age
August 02 2017 - 1:30AM
Press Release
Montrouge, France,August 2, 2017 |
DBV Technologies Initiates Phase III
Study of Viaskin Peanut in Peanut-Allergic Patients One to Three
Years of Age
Expansion of clinical program into younger children reinforces
commitment to developing potential treatments for patients
suffering from peanut allergy
DBV Technologies (Euronext: DBV -
ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced
that the first patient has been enrolled in EPITOPE (EPIT in TOddlers with PEanut Allergy), a global, Phase III clinical trial
assessing the safety and efficacy of Viaskin Peanut for the
treatment of peanut-allergic patients one to three years of age.
Viaskin Peanut is the company's lead product candidate, which is
based on epicutaneous immunotherapy (EPIT), a proprietary
technology platform that delivers biologically active compounds to
the immune system through the skin.
"With results from our ongoing Phase III trial of
Viaskin Peanut in peanut-allergic children four to 11 years of age
expected later this year, the launch of EPITOPE, our second Viaskin
Peanut Phase III program, highlights our commitment to accelerating
innovation in the field of food allergies," said Dr. Hugh Sampson, Chief Scientific Officer of DBV
Technologies, Director of the Jaffe Food Allergy Institute at Mount
Sinai, and the Kurt Hirschhorn Professor of Pediatrics at the Icahn
School of Medicine at Mount Sinai. "Recent studies
in the field suggest that treating patients from a younger age may
lead to significant therapeutic benefit, and Viaskin may be able to
offer a safe, effective and convenient treatment for these younger
children."
EPITOPE is a two-part, pivotal, double-blind, placebo-controlled
Phase III trial designed to evaluate the safety and efficacy of
Viaskin Peanut in children one to three years of age. Part A of the
trial will assess the safety of two doses of Viaskin Peanut, 100 µg
and 250 µg in approximately 50 patients for three months. Based on
the results from Part A, the highest safe dose will be studied in
Part B, which will enroll approximately 281 additional patients to
evaluate the safety and efficacy of the identified dose versus
placebo for 12 months. The primary efficacy endpoint of the study
is based on a responder analysis after 12 months of treatment of
Viaskin Peanut. Efficacy will be assessed using a double-blind,
placebo controlled food challenge (DBPCFC).
Dr. Wesley
Burks, Curnen Professor of Pediatrics, University of North
Carolina School of Medicine, and Principal Investigator of the
EPITOPE study, said: "Seeing the first patient
enrolled in this trial represents another important step forward
towards exploring treatments for patients suffering from peanut
allergy. We have seen an increase in the diagnosis of this disease
within the first few years of life, representing a high unmet
medical need for these young children."
About
EPITOPE
EPITOPE is expected to enroll approximately 331 patients (50 in
Part A and 281 in Part B) in approximately 20 - 40 centers across
North America (Canada and the United States), Ireland, and
Australia.
The EPITOPE trial is a two-part
trial: Part A is designed to assess the safety of Viaskin Peanut
100 µg and 250 µg to determine the highest safe dose, and Part B is
designed to assess the safety and efficacy of the highest safe dose
selected in Part A. In Part A, patients are randomized 1:2:2 to
receive either placebo or Viaskin Peanut 100 mcg or 250 mcg for
three months. A safety analysis will be performed after three
months to determine the highest safe dose to be studied in Part B.
If there are no safety concerns with either of the two doses,
patients will continue on their respective treatment and remain on
the same active dose or placebo they received in Part A. In Part B,
patients will be randomized 2:1 to receive the selected dose of
Viaskin Peanut or placebo.
The primary endpoint is based on a
responder analysis after 12 months of treatment with the selected
dose of Viaskin Peanut. Efficacy will be assessed using a
double-blind, placebo controlled food challenge (DBPCFC). For
patients with a baseline peanut protein eliciting dose (ED) equal
to or less than 10 mg, a responder is defined as a patient with a
peanut protein ED equal to or greater than 300 mg of peanut protein
after 12 months of treatment. For patients with a baseline ED
greater than 10 mg, a responder is defined as a patient with a
peanut protein ED equal to or greater than 1,000 mg of peanut
protein after 12 months of treatment. As a secondary efficacy
endpoint, Cumulative Reactive Dose (CRD), will also be evaluated in
EPITOPE to establish the total quantity of peanut protein that
triggers patient reactions at month 12 of active treatment versus
placebo. Serological markers will also be measured at baseline, 3,
6, and 12 months in order to characterize the immunological changes
in patients.
About DBV
Technologies
DBV Technologies is developing Viaskin®, a proprietary technology
platform with broad potential applications in immunotherapy.
Viaskin is based on epicutaneous immunotherapy, or EPIT®, DBV's
method of delivering biologically active compounds to the immune
system through intact skin. With this new class of
self-administered and non-invasive product candidates, the company
is dedicated to safely transforming the care of food allergic
patients, for whom there are no approved treatments. DBV's food
allergies programs include ongoing clinical trials of Viaskin
Peanut and Viaskin Milk, and preclinical development of Viaskin
Egg. DBV is also pursuing a human proof-of-concept clinical study
of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and
exploring potential applications of its platform in vaccines and
other immune diseases.
DBV Technologies has global headquarters in Montrouge, France and
New York, NY. Company shares are traded on segment A of Euronext
Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120
index, and traded on the Nasdaq Global Select Market in the form of
American Depositary Shares (each representing one-half of one
ordinary share) (Ticker: DBVT). For more information on DBV
Technologies, please visit our website:
www.dbv-technologies.com
Forward Looking
Statements
This press release may contain forward-looking statements and
estimates, including statements regarding the potential of Viaskin
Peanut. These forward-looking statements and estimates are not
promises or guarantees and involve substantial risks and
uncertainties. At this stage, the products of the Company 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 the risk that
historical clinical results in one patient population may not be
predictive of future clinical trial results in different patient
populations. A further list and description of these risks,
uncertainties and other risks can be found in the Company's
regulatory filings with the French Autorité des Marchés Financiers,
the Company's Securities and Exchange Commission filings and
reports, including in the Company's Annual Report on Form 20-F for
the year ended December 31, 2016 and future filings and reports by
the Company. 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.
DBV Technologies
Contact
Sara Blum Sherman
Director, Investor Relations
+1 212-271-0740
sara.sherman@dbv-technologies.com
Media
Contact
Andrea Fassacesia, Weber Shandwick
+1 212-445-8144
afassacesia@webershandwick.com
Media Contact
Europe
Caroline Carmagnol, Alize RP, Relations
Presse
+33 (0)6 64 18 99 59
caroline@alizerp.com
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Source: DBV Technologies via Globenewswire
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