DBV Technologies Completes Enrollment of Phase II Study of Viaskin Milk for the Treatment of Milk Allergic Patients

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), today announced that enrollment for Part B, or Phase II, of the Phase I/II study of Viaskin Milk for the treatment of patients with IgE-mediated cow’s milk protein allergy (CMPA) has been completed. The MILES trial is evaluating the efficacy and safety of Viaskin Milk in desensitizing children two to 17 years of age suffering from CMPA. The Viaskin Milk patch is based on DBV’s epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin. The blinded part of the MILES study is expected to complete in the second half of 2017.

No safety concerns were observed during Part A of the MILES Study (Phase
I), for which study results were presented at the 2016 American Academy
of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles,
CA, on March 6, by Karine Rutault, Director, Clinical Projects, DBV
Technologies. In Phase II, or Part B of the MILES study, a total of 283
patients were screened. The Company expects approximately 176 children
with IgE-mediated CMPA will be randomized 1:1:1:1 to receive one of the
three doses of Viaskin Milk (150 µg, 300 µg, 500 µg) or placebo for 12
months.
“This is an important milestone for the treatment of pediatric CMPA,
a disease affecting millions of patients worldwide, who are often times
at risk of experiencing life-threatening reactions to undetectable
traces of cow’s milk protein in their everyday lives,” said Dr.
Anna Nowak-Wegrzyn, Associate Professor, Pediatrics, Allergy and
Immunology at Jaffe Food Allergy Institute, Mount Sinai School of
Medicine in New York and the Principal Investigator of the MILES trial
at Mount Sinai Medical Center. “CMPA is one of the most common food
allergies in children today and we look forward to seeing the results
from this groundbreaking trial. Viaskin Milk, if proven safe and
effective in clinical trials, could be the first product candidate to
offer a potential treatment option for these patients, if approved.”
About the MILES Study
The Viaskin Milk Efficacy and Safety (MILES) trial
is a multi-center, double-blind, placebo-controlled, randomized Phase
I/II trial to study the safety and efficacy of Viaskin Milk in pediatric
patient populations (age two to 17) suffering from IgE-mediated cow’s
milk protein allergy, or CMPA, with elevated IgE levels related to cow’s
milk protein. The trial is being conducted in select U.S. and Canadian
clinical centers. Part A of the MILES trial has been completed with no
safety concerns. Approximately 194 subjects are expected to be
randomized for treatment at 17 sites, including 18 subjects from Part A
and 176 subjects from Part B, under the proposed amended MILES Part B
protocol. Eligible subjects with confirmed IgE-mediated CMPA will
perform an initial food challenge at screening with escalating doses of
cow’s milk proteins. Subjects who display objective symptoms of an
allergic response to an eliciting dose of 300 mg cow’s milk proteins
(approximately 9.4 mL of cow’s milk) or below will be randomized in the
trial. The primary efficacy endpoint will be the percentage of subjects
who are treatment responders after 12 months, defined as subjects who
meet at least one of the following criteria: (1) a 10-fold or greater
increase in the cumulative reactive dose, or CRD, of cow’s milk proteins
at month 12 of the food challenge as compared to baseline value in
addition to reaching tolerance to at least 144 mg of cow’s milk protein
(approximately 4.5 mL of milk) or (2) a CRD of cow’s milk protein
greater than or equal to 1,444 mg (approximately 45 mL of milk) at month
12 of the food challenge. Secondary efficacy endpoints include, among
others, the percentage of subjects who are treatment responders at month
24, the mean and median CRD of cow’s milk proteins at months 12 and 24
as well as the change in CRD from baseline, the change from baseline in
the severity of symptoms elicited during the food challenge from
baseline to months 12 and 24, and the change from baseline in quality of
life assessments at months 12 and 24.
About Viaskin Milk
Viaskin Milk is an investigational therapy in development for the
treatment of pediatric cow’s milk protein allergy (CMPA) and
Eosinophilic Esophagitis (EoE). The Viaskin Milk patch is based on
epicutaneous immunotherapy (EPIT), a proprietary technology platform
that can deliver biologically active compounds to the immune system
through intact skin without allowing compound passage into the blood.
About Cow’s Milk Protein Allergy
Cow’s milk protein allergy (CMPA) is the most common food allergy in
infants and young children, affecting 2% to 3% of the general
population. Symptoms can include gastrointestinal problems such as
vomiting and diarrhea, skin rash, angioedema or rapid swelling of the
skin, and anaphylaxis. The only option available for CMPA management is
the avoidance of cow’s milk, which can lead to issues of dietary
imbalance, failure to thrive and poor quality of life.
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 B 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 Milk
and statements reflecting management’s expectations for clinical
development of Viaskin Milk and the commercial potential of Viaskin
Milk. 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.