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DBV Technologies: Topline Results from Two-Year Follow-Up Study of Viaskin Peanut Show Long-Lasting and High Levels of Desensitization to Peanut

| Press Release |
| |
|Montrouge, France, October 24, 2016 |

Topline Results from Two-Year Follow-Up Study of Viaskin Peanut Show Long-Lasting and High Levels of Desensitization to PeanutFavorable safety and high compliance were reported in OLFUS, consistent with
prior results

A vast majority of children continue to respond to treatment and tolerate
larger doses of peanut, including patients treated with Viaskin Peanut 250
micrograms for up to 36 months

Peanut-specific biomarkers reflect strong immunomodulation in patients

After two months of treatment discontinuation, sustained responses were
observed in all children who qualified for and completed a food challenge at

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), today announced topline results from the two-year OLFUS-VIPES study
supporting the durable effect and favorable safety profile of Viaskin Peanut
for the treatment of peanut-allergic children. OLFUS-VIPES, or OLFUS, is an
open-label, follow-up study to VIPES, the Company's Phase IIb clinical trial
of Viaskin Peanut. Previously, the Company reported positive results from
VIPES in September 2014 and provided an interim analysis from the first 12
months of OLFUS in October 2015.

Investigators in OLFUS followed patients who completed the VIPES study for an
additional 24 months in order to assess the long-term safety and efficacy of
Viaskin Peanut beyond the VIPES primary endpoint at 12 months. As in VIPES,
participants' response to treatment[i]was evaluated by a double-blind,
placebo-controlled food challenge (DBPCFC), which was administered at
month-12 and month-24 during the OLFUS study.

Consistent with prior observations in OLFUS, the favorable safety,
tolerability and compliance profile of Viaskin Peanut was maintained from
year-1 to year-2, with no treatment-related epinephrine use or serious
adverse events (SAEs) reported in any of the subgroups. Patient compliance,
which measures adherence to treatment dosing, was maintained at a median rate
of 95.5%.

Highlights from the two-year follow-up results in children:

Children treated with Viaskin Peanut 250 micrograms throughout the duration of
VIPES and OLFUS were observed to maintain long-lasting desensitization to
peanut for a total of 36 months. Observations in these patients include the

* Treatment benefit was observed to be long-lasting, with 83% (15/18) of
children continuing to respond to treatment during the second year of
* By month-24, a significant proportion of children were tolerating larger
doses of peanut compared to the OLFUS baseline.
* Mean and median cumulative reactive dose (CRD) of peanut protein, which
measures threshold reactivity during the DBPCFC, progressed to 2,454 mg and
1,440 mg, respectively, at the completion of OLFUS; from 1,884 mg and 1,440
mg, respectively, during the month-12 interim assessment; and from 1,068 mg
and 444 mg, respectively, at the OLFUS baseline.
* Several children reached a CRD of at least 5,040 mg of peanut protein at
the completion of the study (7/18 patients).
* Peanut-specific immunoglobulin E (IgE) levels were maintained below
baseline from year-1 to year-2, and immunoglobulin G4 (IgG4) levels
remained high.
* After two years, 14% (3/21) of patients in this cohort discontinued
treatment, none reportedly related to Viaskin Peanut.

"Peanut allergy is a debilitating disease affecting millions of patients
worldwide, but despite its rapidly increasing prevalence there are still no
FDA approved treatments. These results help validate the potential of Viaskin
Peanut to generate meaningful and long-lasting desensitization to peanuts in
children ages four to 11. If the product is approved after the ongoing Phase
III trial, we will be one step closer to providing peanut allergic children
with protection against the life-threatening risks associated with accidental
allergen exposure,"
saidDr. Stephen A. Tilles,
Executive Director, ASTHMA Inc. Clinical Research Center, Physician Partner at
Northwest Allergy&Asthma Center (NAAC), and Site Principal Investigator for
the OLFUS study in Seattle."One of Viaskin Peanut's most important attributes
has been its safety and
tolerability profile. This is likely the reason for the high degree of
treatment adherence during this several year study, and may be an important
determinant of its success in clinical practice."

Despite treatment with suboptimal dose regimens, children treated with Viaskin
Peanut 50 micrograms or 100 micrograms in VIPES, who later received the 250
micrograms dose during OLFUS, showed increased levels of desensitization at
month-24. Additional exploratory observations include the following:

* A majority of children receiving suboptimal dose regimens responded to
treatment by the completion of OLFUS.
* Patients generally increased oral peanut intake over time in a
dose-dependent manner.
* Patients initially treated with the lowest dose were more likely to
discontinue therapy and were also less likely to achieve the highest CRD
levels at month-24.

Preliminary analysis on sustained benefit following treatment discontinuation:

All subjects who were unresponsive to a cumulative reactive dose of above
1,440 mg of peanut protein at the month-24 DBPCFC in OLFUS were eligible to
continue the study for two additional months. During this period, patients
did not receive treatment and were required to maintain a peanut-free diet.
In an exploratory analysis, all of the 19 children who completed the DBPCFC
at month-26 reached a CRD of at least 1,440 mg, showing a meaningful
durability of response in the absence of treatment.

Complete results from the OLFUS study will be submitted for presentation at a
future medical meeting.

"We would like to thank the patients, caregivers, and clinicians who devoted
their time to complete this long trial,"
saidDr. Hugh Sampson,
Chief Scientific Officer of DBV Technologies, Director of the Jaffe Food
Allergy Institute at Mount Sinai, and Co-Principal Investigator of the
OLFUS-VIPES study. "These three years of epicutaneous immunotherapy data seem
to support DBV's
innovative and proprietary approach of desensitizing food allergic-patients
through the skin in order to minimize safety concerns associated with
allergen exposure. We are also excited to see durable responses in the
absence of treatment and no peanut consumption, although additional analyses
will need to be performed to better understand these findings.
These results suggest that the immunomodulatory changes observed in patients
treated with Viaskin may be more sustained


fficacy andS
afety), 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 micrograms or Viaskin Peanut 100 micrograms or Viaskin
Peanut 250 micrograms for 12 months. According to a study protocol change
implemented in March 2014, all patients were switched to receive Viaskin
Peanut 250 micrograms 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 1,044 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.


fficacy andS
afety) trial was a double-blind, placebo-controlled, multi-center clinical
trial conducted at 22 sites in North America and Europe. 221 peanut-allergic
subjects were randomized 1:1:1:1 into four treatment arms to evaluate three
doses of Viaskin Peanut, 50 micrograms, 100 micrograms and 250 micrograms,
compared to placebo. Each patient underwent two DBPCFCs: one at screening and
one after 12 months of treatment. The challenge was halted once the subject
exhibited an objective allergic symptom. Patients in VIPES received a daily
application of the Viaskin Peanut patch over 12 months. Each patch was
applied for 24 hours on the upper arm for adults (age 18-55) and adolescents
(age 12-17) or on the back of children (age 6-11). The primary efficacy
endpoint was the percentage of treatment responders for each active treatment
group compared to placebo. With Viaskin Peanut 250 micrograms, 53.6% of
children were observed to respond to treatment compared to a 19.4% response
rate in the placebo group (p=0.008). The compliance rate was more than 97%
across all cohorts, the dropout for related adverse events was less than 1%,
and there were no reported serious adverse events or epinephrine injection
related to treatment.

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
as well as New Jersey, CT. 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 t...

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