DBV Technologies Announces Completion of Enrollment of the REALISE Study in Peanut Allergic Children
(Thomson Reuters ONE) -
Press Release
Montrouge, France, March 10, 2017
DBV Technologies Announces Completion of Enrollment of the REALISE Study in
Peanut Allergic Children
Higher-than-expected patient demand leads to increased randomization target
Study includes patients with or without a history of severe anaphylaxis
Global Phase III program results expected in 2H 2017
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT) today announced that patient enrollment in the REALISE (REAL Life Use and
Safety of EPIT) trial was completed. REALISE is the company's Phase III study
designed to assess the safety and routine clinical use of Viaskin Peanut 250 µg
for the treatment of peanut allergic children four to 11 years of age, including
patients with a history of severe anaphylaxis. Viaskin Peanut is the company's
lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a
proprietary technology platform that can deliver biologically active compounds
to the immune system through the skin.
Enrollment in the REALISE study exceeded initial expectations. A total of 483
patients were screened, and the company increased its initial randomization
target of 335 patients to approximately 394 patients. Topline results from the
REALISE trial as well as the PEPITES trial, the company's pivotal Phase III
safety and efficacy trial, are expected in the second half of 2017.
Dr. Jacqueline Pongracic, Head, Allergy and Immunology, Ann & Robert H. Lurie
Children's Hospital of Chicago, Professor of Pediatrics and Medicine,
Northwestern University Feinberg School of Medicine, and Principal Investigator
of REALISE, said: "We eagerly anticipate the results from this novel study,
which is leading the way towards the advancement of treatment for peanut-
allergic children. Importantly, we are pleased to see a study that includes
patients with a history of severe anaphylaxis, a population that has
historically been excluded from previous clinical trials, and represent a
significant unmet clinical need."
"The high level of interest from patients and the rapid completion of enrollment
in REALISE further highlight the need for a treatment of this potentially life-
threatening condition," said Dr. Lucia Septién, Chief Medical Officer of DBV
Technologies. "Following the successful enrollment in PEPITES, we are pleased to
see continued excitement from patients, caregivers, and clinicians, and would
like to thank them for their participation and support in our trials."
About the REALISE Study
REALISE is a multicenter, randomized, double-blind, placebo-controlled Phase III
study designed to assess the use of Viaskin Peanut 250 mcg in routine medical
practice and generate safety data after six months of blinded treatment in
patients four to 11 years of age. At the six-month time point, patients in both
the placebo and active arms will be able to opt into an open-label portion of
the study, which will continue monitoring patients for a total of 36 months of
active treatment. Exploratory criteria will also include scores from patients'
Food Allergy Quality of Life Questionnaire (FAQLQ) and the Food Allergy
Independent Measure (FAIM), as well as the evolution of peanut-specific
serological markers over time. The study is being conducted in 32 centers in
North America. No oral food challenges are required in REALISE. Patients in the
study will be selected based on a well-documented medical history of IgE-
mediated reactions to peanut, including children with a history of severe
anaphylaxis, as well as analyses of baseline peanut-specific immunological
markers. During the first six months of trial, patients will be randomized 3:1
active versus placebo. Key assessments of safety parameters will include
treatment-emergent adverse events observed in both the placebo and active
treatment groups during the initial six months, which will continue to be
monitored during the open-label portion of the study. DBV intends to randomize
approximately 394 patients in REALISE.
About the PEPITES Study
The Peanut EPIT Efficacy and Safety Study (PEPITES) is a global, pivotal,
double-blinded, placebo-controlled Phase III trial designed to evaluate the
safety and efficacy of Viaskin Peanut 250 mcg in children ages four to 11 years.
During PEPITES, patients' response will be assessed using a double-blind,
placebo controlled food challenge (DBPCFC). Patients are randomized 2:1 to
receive either Viaskin Peanut 250 mcg or placebo for 12 months. The primary
endpoint is based on a responder analysis after 12 months of treatment with
Viaskin Peanut 250 µg. 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 used in PEPITES
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.
Following the completion of PEPITES, all patients are eligible to rollover into
PEOPLE, a long-term, open-label extension study of Viaskin Peanut 250 µg. In the
PEOPLE study, patients who were randomized to active treatment during PEPITES
will receive Viaskin Peanut 250 mcg for two additional years; patients who were
previously receiving placebo during PEPITES will be treated with Viaskin Peanut
250 mcg for three years. Patients enrolling in the PEOPLE study will remain
blinded to their respective treatment group in PEPITES until the PEPITES study
results become publicly available.
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 safety and efficacy of Viaskin
Peanut, statements regarding the anticipated timing of data from clinical trials
and statements reflecting management's expectations for clinical development of
our product candidates and the commercial potential of our product candidates.
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, the
risk that historical preclinical results may not be predictive of future
clinical trial results, and the risk that historical clinical trial results may
not be predictive of future trial results. 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, 2015
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
Susanna Mesa
Senior Vice President, Strategy
+1 212-271-0861
susanna.mesa(at)dbv-technologies.com
Media Contact
Andrea Fassacesia, Weber Shandwick
+1 212-445-8144
afassacesia(at)webershandwick.com
Media Contact Europe
Caroline Carmagnol, Alize RP, Relations Presse
+33 (0)6 64 18 99 59
caroline(at)alizerp.com
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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: DBV Technologies via GlobeNewswire
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