Châtillon, France, November 12, 2026
DBV Technologies Highlights New Data from the VITESSE Phase 3 Study of the VIASKIN® Peanut Patch in Children Ages 4-7 Years
- Additional VITESSE data being presented at 2026 ACAAI Annual Scientific Meeting support safety and efficacy findings from the phase 3 study, and assess potential practical aspects of daily use if approved
- VIASKIN® Peanut Patch treatment was associated with statistically significant reductions in reaction severity during the double-blind, placebo-controlled food challenges after 12 months, including reductions when reactions were assessed at or below participants’ baseline eliciting dose
- Mean treatment compliance was 96.1%; most study participants reported patches were easy and not painful to remove, and no restrictions on daily activities or concomitant medications were required in the study protocol
- VITESSE participants receiving the VIASKIN® Peanut Patch had immunologic changes consistent with allergen immunotherapy, including increased peanut-specific IgG4 and decreased peanut-specific IgE, Ara h 2 IgE and skin-prick-test wheal diameter
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that new data from the successful Phase 3 VITESSE clinical trial of the VIASKIN® Peanut Patch in peanut-allergic children aged 4 to 7 years were highlighted in three presentations at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting in Phoenix, Arizona. The three presentations evaluate changes in allergic reaction severity during double-blind, placebo-controlled food challenges, the potential practicality of the VIASKIN® Peanut Patch using epicutaneous immunotherapy (EPIT), and changes to immunologic biomarkers during the 12-month VITESSE study.
VITESSE, the largest food allergy immunotherapy trial to date, randomized 654 children 2:1 to receive the VIASKIN Peanut Patch containing 250 µg of peanut protein (VP250) or placebo for 12 months. The study met its primary endpoint, with 46.6% of children in the VIASKIN Peanut Patch arm meeting treatment responder criteria at month 12 compared with 14.8% in the placebo arm (difference in response rates = 31.8%; 95% confidence interval [CI]: 24.5%, 39.0%; p<0.001).
“The VITESSE data presented at ACAAI add important context to the study’s overall positive results,” said Pharis Mohideen, M.D., Chief Medical Officer of DBV Technologies. “After one year of treatment, children receiving the VIASKIN® Peanut Patch in the study had statistically significantly lower maximum symptom severity during food challenge, along with immunologic changes consistent with other forms of allergen immunotherapy. I am also pleased that the practicality data show high treatment compliance in young children with common atopic comorbidities, and that all participants were able to continue their typical daily activities, including bathing, sports and swimming, while on treatment.”
Highlights from the VITESSE data presented at ACAAI 2026:
“Changes in Reaction Severity Following Epicutaneous Immunotherapy in Children with Peanut Allergy”
- At the month 12 double-blind, placebo-controlled food challenge (DBPCFC), maximum symptom severity was significantly lower with the VIASKIN® Peanut Patch versus placebo (p=0.004). Severe reactions occurred in 8.4% of VIASKIN treated participants versus 12.5% of placebo participants; 12.5% of VIASKIN treated participants had no or mild symptoms versus 1.5% with placebo.
- When reactions at month 12 were evaluated at or below each participant’s baseline eliciting dose, 52.7% of VIASKIN treated participants had no symptoms versus 19.2% with placebo, while moderate or severe reactions occurred in 14.0% of VIASKIN treated participants versus 50.0% with placebo.
“Immunologic Changes in VITESSE: A 12-Month Study of Epicutaneous Immunotherapy in Children with Peanut Allergy”
- Peanut-specific IgG4 increased by month 3 with the VIASKIN® Peanut Patch and remained elevated through month 12
- At month 12, median peanut-specific IgE and Ara 2-specific IgE were significantly lower with the VIASKIN® Peanut Patch versus placebo (p=0.001).
- Mean skin-prick-test wheal diameter decreased significantly with the VIASKIN® Peanut Patch versus placebo at month 12 (least-squares mean ratio: 0.74; 95% CI: 0.69, 0.79; p<0.0001).
- VIASKIN® Peanut Patch treatment for one year resulted in statistically significant greater responder rates versus placebo and immunomodulatory changes consistent with other forms of allergen immunotherapy.
“Practicality of Daily Epicutaneous Immunotherapy in Young Children with Peanut Allergy”
- Mean treatment compliance was high in both groups (96.1% with the VIASKIN® Peanut Patch and 96.5% with placebo).
- Most patches were rated by participants as “very easy” or “easy” to remove (83.4% with the VIASKIN® Peanut Patch; 84.8% with placebo) and “not painful” to remove (71.9% with the VIASKIN® Peanut Patch; 70.2% with placebo).
- Participants continued typical daily activities, including bathing/showering, play, sports and swimming, with no restrictions on daily activities or concomitant medication use required during the study.
- Atopic comorbidities were common among VITESSE participants, including atopic dermatitis, other food allergies and asthma.
“When I work with families in the clinic, the treatment conversations are not just about safety and efficacy, but practical considerations such as time commitment, how a treatment might fit into family life and family routines, and impact on the child,” said Edwin H. Kim, M.D., Associate Professor of Pediatrics at the University of North Carolina School of Medicine. “These additional data from VITESSE are clinically meaningful and I believe support the potential of the VIASKIN® Peanut Patch to be integrated into the daily routines of children living with peanut allergy, if approved.”
The presentations will be made available on the Scientific Publications & Presentations page on the Company’s website following presentation at the meeting.
About DBV Technologies
DBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.
VIASKIN is a registered trademark of DBV Technologies.
Forward Looking Statements
This press release may contain forward-looking statements, including statements regarding the therapeutic potential of VIASKIN® Peanut patch and EPIT, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, clinical trial data release and publications, , and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. 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, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, DBV’s Quarterly Report on Form 10-Q filed with the SEC on October 28, 2026, and future filings and reports made with the SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.
Investor Contact
Virginie Boucinha
DBV Technologies
Virginie.Boucinha@dbv-technologies.com
Media Contact
Brett Whelan
DBV Technologies
brett.whelan@dbv-technologies.com
Attachment
