Full Press Release Details
Bagneux, France, February 24, 2015
Viaskin Data Presented at AAAAI Meeting Show Safety and Efficacy in the Treatment of Food Allergies
VIPES Phase IIb data supports Viaskin Peanut safety and efficacy in the treatment of peanut
Preclinical data highlighted the unique and long-lasting therapeutic profile of Epicutaneous Immunotherapy (EPIT )
DBV will provide development milestones for the Viaskin Platform during an Analyst & Investor briefing
DBV Technologies (Euronext: DBV
ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, today announced that further clinical and preclinical data supporting the use DBV s proprietary technology, Viaskin for EPIT , in the potential treatment of food allergies were presented at the 2015 Annual Meeting of the American Academy of Allergy,
Asthma & Immunology (AAAAI) in Houston, Texas, February 20-24. During a separate analyst and investor briefing, DBV will also provide a strategic update delineating development milestones for Viaskin in food allergies, allergic diseases, immunology, and vaccines.
Benhamou, Chairman & CEO of DBV Technologies, said: We are excited to be at the verge of revolutionizing the field of allergy, and our strong presence at AAAAI highlights Viaskin s role in changing the way we think
about these diseases. Food allergic patients, especially children, have long awaited for a safe and effective treatment, and we are close to meeting their medical needs. Dr. Benhamou continued: In addition to the data on
Viaskin Peanut s clinical trial, which is the largest peanut allergy immunotherapy study that has ever been conducted, our other presentations and posters continue to characterize the uniqueness of EPIT s mechanism of action, which we
believe could target all food allergies safely and effectively with a long lasting effect.
Pr. Hugh A. Sampson, MD, FAAAAI, Director of
the Jaffe Food Allergy Institute at the Kravis Children s Hospital at Mount Sinai and first author of the late-breaking abstract commented: EPIT appears safe, well tolerated and effective. That s good news for families who suffer
from food allergies Sampson said.
DBV s data presentations at AAAAI included three oral presentations and three poster sessions
highlighting EPIT s role in the treatment of food allergies.
Clinical Presentations Highlights
In an oral presentation titled Epicutaneous Immunotherapy (EPIT ) Is Effective and Safe to
Treat Peanut Allergy: A Multi-National Double-Blind Placebo-Controlled Randomized Phase IIb Trial , Dr. Hugh Sampson from Mount Sinai Hospital (New York) concluded that in VIPES, Viaskin Peanut appeared to be safe and effective in
treating peanut allergy patients. In this clinical trial, 221 subjects (6 55 years) reacting to less or at 300 mg peanut protein during a Double-Blind Placebo Controlled Food Challenge (DBPCF) were randomized to Viaskin Peanut doses of 50
g, 100 g, or 250 g, or to placebo. The primary efficacy endpoint, measured after 12 months of treatment, was the proportion of responders with a peanut eliciting dose 10-fold greater than baseline or achieving a post-treatment
eliciting dose of at least 1,000 mg. Cumulative reacting dose (CRD) of peanut protein consumed by subjects was also measured. Immunological markers were studied at entry, 3, 6 and 12 months.
The primary efficacy endpoint was met with Viaskin 250 g, with 50.0% responders vs 25.0% with placebo, p=0.0108. Children in this arm (6-11 years)
exhibited 53.6% responders vs 19.4% for placebo, p=0.0076. In children, the mean CRD showed a Viaskin Peanut dose-dependent response, with a change from Baseline of +61 mg, +471 mg, +570 mg and +1121 mg for the placebo, 50 g, 100 g,
and 250 g arms, respectively. Children s immunological responses were deemed to be robust. In the Viaskin 250 g arm, peanut-specific IgE exhibited a median increase 50 kUA/L at 3
months and decreased back to baseline at 12 months; median peanut-specific IgG4 at 12 months increased in a dose-dependent fashion: 1.3, 5.5-, 7.2- and 19.1-fold for each dose arm, respectively. Viaskin Peanut was observed to be safe in all patient
populations, with a high adherence to treatment reported. The compliance rate was more than 95% across all cohorts, dropout for related adverse events less than 1%, and there were no serious adverse events related to treatment. The top-line results
for VIPES were previously announced by DBV Technologies.
Phenotypic Analysis of Peanut-Responsive T Cells at Baseline in Subjects Enrolled in
CoFAR6, a Randomized Placebo-Controlled Epicutaneous Immunotherapy (EPIT) Trial for the Treatment of Peanut Allergy , which was presented independently by investigators from the Consortium of Food Allergy Research (CoFAR), a NIH/NIAID/DAIT
sponsored research organization, provided baseline peanut-responsive T cells levels for subjects enrolled in the CoFAR6 peanut allergy trial (n=75), which is currently ongoing.
Scientific Presentations Highlights
Preclinical data presented
at the meeting focused on characterizing EPIT s mechanism of action. In a poster titled, Epicutaneous Immunotherapy Prevents from Induction of Anaphylaxis to Further Allergen, Dr. Lucie Mondoulet, Director of Research at
DBV, demonstrated in a mice model that T cells (Tregs) induced via EPIT play an important role in protecting against multiple allergen sensitization. Dr. Mondoulet suggests that early treatment with Viaskin may prevent the development of subsequent allergic diseases.
Other presentations highlighted EPIT s ability to induce a larger repertoire of homing receptors on
Tregs versus other specific immunotherapies. In Larger and Stronger Expression of Tregs Gut Homing Receptors with EPIT than with Sublingual or Oral Immunotherapy and Epicutaneous but Not Oral Immunotherapy Induces
Antigen-Specific Gastrointestinal Tregs and Protects Against Food-Induced Anaphylaxis EPIT - and not oral immunotherapy - induced antigen-specific gastrointestinal Tregs and provided protection against food-induced anaphylaxis, independent
of the initial route of sensitization.
Epigenetic mechanisms modulated during EPIT were also described in Epigenetic changes following
epicutaneous immunotherapy in peanut sensitized mice . The poster concluded that epigenetic modifications of the DNA methylation of Th2 and Treg transcription factor appear to be a major trait of EPIT-induced immunomodulation, which may
explain the long-lasting therapeutic and preventive effect that was observed in mice that were treated with EPIT versus Sham.
Analyst & Investor Briefing
In addition to data presented at AAAAI, DBV will host an analyst and investor briefing, where it will provide
development objectives for the Viaskin Platform, including:
About DBV Technologies
DBV Technologies is developing Viaskin , an innovative new approach to the treatment of allergies
a major public health issue that has been increasing in prevalence. DBV Technologies, incorporated in France in 2002, has developed a proprietary, worldwide-patented technology for administering an allergen to intact skin while avoiding
transfer to the blood, and thus considerably lowering the risk of a systemic, allergic reaction in the event of accidental exposure. DBV Technologies is focusing on food allergies, including milk and peanut, for which there are currently no
effective treatments. DBV Technologies has designed two products candidates: Viaskin Peanut and Viaskin Milk. The clinical
development program for Viaskin Peanut has received Fast Track designation from the US Food and Drug Administration.
DBV Technologies shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and on the Nasdaq Stock 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 about the safety and efficacy of Epicutaneous Immunotherapy (EPIT) via Viaskin, including the potential to prevent sensitizations in other allergens, the potential to induce a sustained protection
effect and the potential to influence the natural history of allergy. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular it should be noted that these data are preclinical
in nature and have not been demonstrated in human subjects. The company s product candidates have not been approved for sale in any jurisdiction. 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 Autorit des March s Financiers, the Company s Securities and Exchange Commission filings and reports, including in the Company s prospectus filed with the SEC on October 22, 2014 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 Contacts | ||
| Susanna Mesa VP Finance, US Investor Relations & Strategy T l. : +1 917-346-3447 susanna.mesa@dbv-technologies.com | Nathalie Donne Director, Corporate Communication & Business Development T l. : +33(0)1 55 42 78 72 nathalie.donne@dbv-technologies.com | |
| DBV Technologies IR and Media Contacts | ||
| Marion Janic US Media Relations Rooney & Associates T l. : +1-212-223-4017 mjanic@rooneyco.com |