Jueves 20 de Septiembre 2018

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

Favorable 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 µg 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 month-26

MONTROUGE, France–(BUSINESS WIRE)–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 treatment1 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 μg 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 following:

  • Treatment benefit was observed to be long-lasting, with 83% (15/18) of
    children continuing to respond to treatment during the second year of
    OLFUS.
  • 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,”
said
Dr. 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 μg or 100 μg in VIPES, who later received the 250 μg
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,”
said Dr.
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.”

About OLFUS-VIPES

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 μg 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.

About VIPES

The VIPES (Viaskin Peanut’s Efficacy and Safety)
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 µg, 100 µg and 250
µg, 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 µg, 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 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 reflecting management’s expectations regarding the clinical
development of Viaskin Peanut, the safety, efficacy and durability of
Viaskin Peanut for the treatment of peanut allergy, and the commercial
potential of Viaskin Peanut. 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
clinical trial results may not be predictive of future trial results and
the risk that Viaskin Peanut may not receive regulatory approval
notwithstanding the results of clinical trials. 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.

1 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 OLFUS eliciting
dose compared to the baseline eliciting dose observed in the VIPES study.

Contacts

DBV Technologies
Susanna Mesa, +1 212-271-0861
Senior
Vice President, Strategy
susanna.mesa@dbv-technologies.com
or
Media
Centron
PR

Erinn White, +1-646-722-8822
ewhite@centronpr.com
or
Media
Europe

Alize RP
Caroline Carmagnol, +33 (0)6 64 18
99 59
Relations Presse
caroline@alizerp.com