DBV to Present Data at the 2017 AAAAI Meeting Highlighting the Therapeutic Potential of EPIT®
(Thomson Reuters ONE) -
Press Release
Montrouge, France, February 10, 2017
DBV to Present Data at the 2017 AAAAI Meeting Highlighting the Therapeutic
Potential of EPIT(®)
Eight abstracts, including detailed two-year follow-up data to the VIPES Phase
IIb trial supporting the long-term efficacy and safety of Viaskin Peanut for the
treatment of peanut allergy, will be presented during the meeting
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), today announced that eight abstracts, seven of which will highlight data
from the company's Viaskin technology platform, were accepted for oral and
poster presentation at the 2017 American Academy of Allergy, Asthma & Immunology
(AAAAI) Annual Meeting in Atlanta, Georgia, March 3-6, 2017. These abstracts
became available on the AAAAI meeting website at 9:30 AM CT on February 10
http://annualmeeting.aaaai.org/.
Detailed results from the OLFUS-VIPES trial, which followed patients for a total
of 36 months, will be presented during the Late Breaking Oral Abstract Session
on Sunday, March 5. Topline results from OLFUS-VIPES, which evaluated the long-
term efficacy and safety of Viaskin Peanut for the treatment of peanut-allergic
children, were previously announced in October 2016. Viaskin Peanut is the
company's lead product candidate based on its proprietary EPIT platform, which
aims to deliver biologically active compounds to the immune system through the
skin, and is currently being evaluated in a global, pivotal Phase III program in
peanut-allergic children 4 to 11 years of age.
"The long-term clinical data we are presenting at AAAAI provide further insight
into the promise of Viaskin Peanut as a potential treatment option for peanut-
allergic children," said Dr. Lucia Septién, Chief Medical Officer of DBV
Technologies. "These detailed results, combined with pre-clinical data that will
be presented at the meeting, also underscore the tremendous potential of EPIT to
help address a wide range of unmet medical needs."
Additional abstracts to be presented at the meeting include two pre-clinical
studies, which tested the therapeutic potential of EPIT in type 1 diabetes and
in the vaccination against respiratory syncytial virus (RSV).
Selected abstracts of interest:
Peanut Allergy Data
* "Efficacy and Safety of Long-Term Epicutaneous Immunotherapy (EPIT)
Treatment of Peanut Allergy with Viaskin® Peanut: Results of the Two-Year
Extension of the VIPES Phase IIb Clinical Trial" will be presented by Dr.
Wayne G. Shreffler, Division of Allergy and Immunology, Department of
Pediatrics, Massachusetts General Hospital, Harvard Medical School.
* Oral Presentation
* Session Number: 3611
* Poster Number: L7
* Session Title: Late Breaking Oral Abstract Session:
Clinical/Translational Science
* Date/Time: Sunday, March 5 / 2:15 PM to 2:30 PM
FARRP (Food Allergy Research & Resource Program) Data
* "Increasing Clinical Peanut Thresholds Through Immunotherapy: Quantitative
Assessment of the Safety Benefits Associated with Achieving a 300 or 1000 mg
Peanut Protein Threshold" will be presented by Dr. Joseph L. Baumert, Food
Allergy Research and Resource Program, University of Nebraska-Lincoln.
* Oral Presentation
* Session Number: 3604
* Poster Number: 561
* Session Title: Immunotherapy for Food Allergy
* Date/Time: Sunday, March 5 / 2:45 PM to 3:00 PM
RSV Data
* "Preclinical evaluation of a novel non-invasive epicutaneous vaccine against
respiratory syncytial virus" will be presented by Dr. Pierre-Louis Hervé,
DBV Technologies.
* Session Number: 3802
* Poster Number: 589
* Session Title: Immunotherapy: How to Reprogram the Immune System
* Date/Time: Sunday, March 5 / 4:45 PM to 6:15 PM
Type 1 Diabetes Data
* "EPIT decreases T1D incidence in sensitized non obese diabetic mice: a
likely bystander effect of EPIT-induced Tregs" will be presented by Dr.
Benjamin Pelletier, DBV Technologies.
* Poster Session
* Session Number: 2203
* Poster Number: 52
* Session Title: Immune Modulation
* Date/Time: Saturday, March 4 / 9:45 AM to 10:45 AM
EPIT Mechanism of Action Research
* "Treatment of eosinophilic gastritis by Epicutaneous Immunotherapy (EPIT) in
peanut allergic piglets" will be presented by Dr. Lucie Mondoulet, DBV
Technologies.
* Poster Session
* Session Number: 2208
* Poster Number: 153
* Session Title: Eosinophilic Gastrointestinal Disorders and Non-IgE
Mediated Food Allergy
* Date/Time: Saturday, March 4 / 9:45 AM to 10:45 AM
* "Allergen Capture by DCs during Epicutaneous Immunotherapy is Enhanced by
Modulating the Dose and the Surface Area of the Patch" will be presented by
Dr. Sophie Wavrin, DBV Technologies.
* Poster Session
* Session Number: 4210
* Poster Number: 806
* Session Title: Allergen Extracts and Other Forms of Immunotherapy
* Date/Time: Monday, March 6 / 9:45 AM to 10:45 AM
* "Crucial Role of Langerhans Cells in Allergen Uptake and Regulatory T Cell
Induction in Epicutaneous Immunotherapy" will be presented by Dr. Vincent
Dioszeghy, DBV Technologies.
* Poster Session
* Session Number: 4210
* Poster Number: 805
* Session Title: Allergen Extracts and Other Forms of Immunotherapy
* Date/Time: Monday, March 6 / 9:45 AM to 10:45 AM
* "Foxp3+ CD62L+ Tregs induced by EPIT have the potency to suppress effector T
cells proliferation in specific and bystander conditions" will be presented
by Dr. Benjamin Pelletier, DBV Technologies.
* Session Number: 4210
* Poster Number: 801
* Session Title: Allergen Extracts and Other Forms of Immunotherapy
* Date/Time: Monday, March 6 / 9:45 AM to 10:45 AM
Full data will be shared following embargo lift; at the time the studies are
presented. All abstracts are available online at
http://annualmeeting.aaaai.org/, and will also be published in a supplement to
the February Journal of Allergy and Clinical Immunology (JACI) at
http://www.jacionline.org/.
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 subjects 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 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 subjects'
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 expected to be conducted in
approximately 30 to 40 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 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 after the initial 6 months, which will
continue to be monitored during the open-label portion of the study. DBV intends
to enroll approximately 335 subjects in REALISE.
About the OLFUS-VIPES Study
OLFUS-VIPES (Open-Label Follow-Up Study-Viaskin Peanut's Efficacy and Safety),
or OLFUS, enrolled 171 subjects who had previously received either placebo or
one of three 12-month dose regimens administered during VIPES. During the first
year of OLFUS, patients were to receive a daily application of Viaskin Peanut
50 µg or Viaskin Peanut 100 µg or Viaskin Peanut 250 µg for 12 months. According
to a study protocol change implemented in March 2014, all patients were switched
to receive Viaskin Peanut 250 mcg during OLFUS. All patients in OLFUS maintained
a peanut-free diet during the study. Baseline response levels in OLFUS were
based on the results of the last double-blind, placebo controlled food challenge
(DBPCFC) in VIPES, and adjusted by the number of patients enrolling in OLFUS.
Responders in the OLFUS trial were defined as subjects with a peanut protein
eliciting dose equal to or greater than 1,000 mg peanut protein or with a
greater than 10-fold increase of the eliciting dose compared to their baseline
eliciting dose observed in the VIPES study. Patients enrolled in OLFUS who
received placebo in VIPES were analyzed separately from subjects who initially
received Viaskin Peanut. At month 24 in OLFUS, patients who were unresponsive to
a cumulative dose above 1,440 mg were eligible to discontinue study drug for two
months while maintaining a peanut-free diet. Patients who opted to enter into
this additional period performed a DBPCFC at month-26 to assess durability of
response.
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 contains forward-looking statements, including statements
regarding the potential safety and efficacy of Viaskin Peanut 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 are not promises or guarantees and involve
substantial risks and uncertainties. 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, which speak only as of the date
hereof. DBV Technologies undertakes no obligation to update or revise the
information contained in this Press Release, whether as a result of new
information, future events or circumstances or otherwise.
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
PDF Version:
http://hugin.info/156437/R/2077894/781771.pdf
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
Unternehmensinformation / Kurzprofil:
Datum: 10.02.2017 - 22:30 Uhr
Sprache: Deutsch
News-ID 523495
Anzahl Zeichen: 16757
contact information:
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Kategorie:
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