DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old
DBV Technologies (NASDAQ:DBVT) has announced the screening of its first subject in the COMFORT Toddlers supplemental safety study for their Viaskin® Peanut patch 250 μg, targeting peanut-allergic children ages 1-3 years old.
The Phase 3 double-blind, placebo-controlled study will enroll approximately 480 subjects across 80-90 study centers in the U.S., Canada, Australia, UK, and Europe. The study includes a 6-month initial phase followed by an optional 18-month open-label treatment phase. The first screening took place at the Respiratory Medicine Research Institute of Michigan, with additional sites in Minnesota and Ontario now activated.
The data from this study will support a Biologics License Application (BLA) submission anticipated in 2H 2026 under the Accelerated Approval Pathway, complementing the previously completed Phase 3 EPITOPE study data.
DBV Technologies (NASDAQ:DBVT) ha annunciato la selezione del primo soggetto nello studio supplementare di sicurezza COMFORT Toddlers per il loro cerotto Viaskin® Peanut da 250 μg, rivolto a bambini allergici alle arachidi di età compresa tra 1 e 3 anni.
Lo studio di Fase 3, in doppio cieco e controllato con placebo, arruolerà circa 480 soggetti in 80-90 centri di studio negli Stati Uniti, Canada, Australia, Regno Unito e Europa. Lo studio prevede una fase iniziale di 6 mesi seguita da una fase di trattamento in aperto opzionale di 18 mesi. Il primo screening si è svolto presso il Respiratory Medicine Research Institute del Michigan, con ulteriori siti attivati in Minnesota e Ontario.
I dati di questo studio supporteranno una domanda di autorizzazione biologica (BLA) prevista per la seconda metà del 2026 tramite la procedura di Approvazione Accelerata, integrando i dati già ottenuti dallo studio di Fase 3 EPITOPE completato in precedenza.
DBV Technologies (NASDAQ:DBVT) ha anunciado la evaluación de su primer sujeto en el estudio complementario de seguridad COMFORT Toddlers para su parche Viaskin® Peanut de 250 μg, dirigido a niños alérgicos al maní de 1 a 3 años.
El estudio de Fase 3, doble ciego y controlado con placebo, inscribirá aproximadamente a 480 sujetos en 80-90 centros de estudio en EE. UU., Canadá, Australia, Reino Unido y Europa. El estudio incluye una fase inicial de 6 meses seguida de una fase opcional de tratamiento abierto de 18 meses. La primera evaluación se realizó en el Respiratory Medicine Research Institute de Michigan, con sitios adicionales activados en Minnesota y Ontario.
Los datos de este estudio respaldarán una solicitud de licencia biológica (BLA) prevista para la segunda mitad de 2026 bajo la vía de Aprobación Acelerada, complementando los datos del estudio de Fase 3 EPITOPE previamente completado.
DBV Technologies (NASDAQ:DBVT)는 1~3세 땅콩 알레르기 아동을 대상으로 한 Viaskin® Peanut 패치 250 μg의 COMFORT Toddlers 추가 안전성 연구에서 첫 번째 대상자 선별을 발표했습니다.
이 3상 이중맹검 위약대조 연구는 미국, 캐나다, 호주, 영국, 유럽의 80~90개 연구 센터에서 약 480명의 대상자를 등록할 예정입니다. 연구는 6개월의 초기 단계와 선택적 18개월 공개 라벨 치료 단계로 구성됩니다. 첫 선별은 미시간 호흡기 의학 연구소에서 진행되었으며, 미네소타와 온타리오의 추가 사이트도 활성화되었습니다.
이 연구의 데이터는 가속 승인 경로에 따라 2026년 하반기 예정인 생물의약품 허가신청(BLA)을 지원하며, 이전에 완료된 3상 EPITOPE 연구 데이터를 보완할 것입니다.
DBV Technologies (NASDAQ:DBVT) a annoncé le dépistage de son premier sujet dans l'étude complémentaire de sécurité COMFORT Toddlers pour leur patch Viaskin® Peanut 250 μg, destiné aux enfants allergiques à l'arachide âgés de 1 à 3 ans.
Cette étude de phase 3, en double aveugle et contrôlée par placebo, recrutera environ 480 sujets répartis dans 80 à 90 centres d'étude aux États-Unis, au Canada, en Australie, au Royaume-Uni et en Europe. L'étude comprend une phase initiale de 6 mois suivie d'une phase de traitement en ouvert optionnelle de 18 mois. Le premier dépistage a eu lieu à l'Institut de recherche en médecine respiratoire du Michigan, avec des sites supplémentaires activés dans le Minnesota et l'Ontario.
Les données de cette étude soutiendront une demande d'autorisation de mise sur le marché biologique (BLA) prévue pour le second semestre 2026 dans le cadre de la procédure d'approbation accélérée, complétant les données précédemment obtenues lors de l'étude de phase 3 EPITOPE.
DBV Technologies (NASDAQ:DBVT) hat die Auswahl des ersten Probanden in der COMFORT Toddlers Zusatz-Sicherheitsstudie für ihr Viaskin® Peanut-Pflaster 250 μg bekannt gegeben, das sich an erdnussallergische Kinder im Alter von 1 bis 3 Jahren richtet.
Die Phase-3-Studie, doppelblind und placebokontrolliert, wird etwa 480 Probanden in 80-90 Studienzentren in den USA, Kanada, Australien, Großbritannien und Europa einschließen. Die Studie umfasst eine 6-monatige Anfangsphase, gefolgt von einer optionalen 18-monatigen offenen Behandlungsphase. Das erste Screening fand am Respiratory Medicine Research Institute in Michigan statt, weitere Standorte in Minnesota und Ontario wurden inzwischen aktiviert.
Die Daten dieser Studie werden eine Biologics License Application (BLA) Einreichung, die für das zweite Halbjahr 2026 erwartet wird, im Rahmen des beschleunigten Zulassungsverfahrens unterstützen und ergänzen die zuvor abgeschlossenen Phase-3-EPITOPE-Studienergebnisse.
- Study will enroll a large cohort of 480 subjects across multiple international centers
- Additional study sites are already activated and scheduling screenings
- Study supports BLA submission under Accelerated Approval Pathway
- Builds upon completed Phase 3 EPITOPE study data
- BLA submission not expected until second half of 2026
- Extended study duration of up to 24 months required
- Product still in clinical trial phase without guaranteed approval
Insights
DBV's COMFORT Toddlers study launch shows clinical progress for Viaskin Peanut patch, advancing toward potential 2026 FDA submission.
DBV Technologies has initiated patient screening in its COMFORT Toddlers supplemental safety study, a critical step in their clinical development pathway for the Viaskin® Peanut patch 250 μg in children ages 1-3 years old. This Phase 3 double-blind, placebo-controlled study will enroll approximately 480 subjects across 80-90 centers internationally, designed to complement the previously completed EPITOPE Phase 3 study in the same age group.
The six-month study includes an optional 18-month open-label extension, potentially generating up to 24 months of treatment data. This design is strategically important as it allows for comprehensive safety assessment while providing extended treatment benefit to participants - a thoughtful approach for a pediatric allergic population with significant unmet needs.
From a regulatory perspective, this study represents the final clinical piece needed for DBV's planned Biologics License Application (BLA) submission to the FDA in the second half of 2026 under the Accelerated Approval Pathway. The company has clearly aligned its development strategy with FDA requirements, which reduces regulatory uncertainty.
The multinational nature of the trial (spanning the U.S., Canada, Australia, UK, and Europe) suggests DBV is positioning for global commercialization rather than a limited regional approach. The company's ability to activate multiple research centers simultaneously demonstrates operational execution capabilities essential for completing enrollment efficiently.
This milestone indicates DBV is advancing its clinical pipeline as planned, keeping the Viaskin Peanut patch on track toward potential marketing authorization for this young patient population with limited treatment options.
Châtillon, France, June 25, 2025
DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old
- First subject screened at the Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein acting as Principal Investigator
- Additional sites, including Allergy and Asthma Center of Minnesota and Hamilton Allergy and Immunology Clinic of Ontario, Canada have been activated and are scheduling screenings
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), a clinical-stage biopharmaceutical company, today provided an update on the progress on the Company’s COMFORT Toddlers supplemental safety study using the Viaskin® Peanut patch 250 μg in peanut-allergic children ages 1 – 3 years old.
COMFORT Toddlers will enroll approximately 480 subjects at approximately 80 – 90 study centers across the U.S., Canada, Australia, UK and Europe. Principal Investigator, Jeffrey Leflein, MD, FAAAAI, FACAAI from the Respiratory Medicine Research Institute of Michigan, in Ann Arbor, Michigan screened the first subject in the study. Additionally, Dr. Doug McMahon, MD, Allergy and Asthma Center in Maplewood, Minnesota and Dr. Jason Ohayon, MD, Hamilton Allergy and Immunology Clinic in Ontario, Canada have been activated and are currently open to recruitment.
"I am thrilled that our talented team of clinicians was the first to screen a subject for the COMFORT Toddlers supplemental safety study and we have several other potential subjects scheduled for screening,” said Dr. Leflein. “The initiation of subject enrollment in COMFORT Toddlers reinforces our commitment to peanut-allergic children and their families and is an important step in generating the data needed to potentially advance the Viaskin Peanut patch to market.”
COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) safety study designed to supplement the safety and efficacy data from the completed Phase 3 EPITOPE study in the same population. The study duration will be six months followed by an optional 18-month open-label treatment phase, to generate up to 24 or 18 months of active treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively.
“I am very pleased subject screening has commenced in COMFORT Toddlers and look forward to working with my fellow investigators on the efficient enrollment and execution of this important study,” stated Julie Wang, MD, FAAAAI, FACAAI, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn School of Medicine at Mount Sinai and Global Principal Investigator for the COMFORT Toddlers study. “The interest we’ve seen to date further reinforces the significant unmet need that exists for this specific subject cohort.”
“Screening our first subject marks a crucial step forward in our mission to develop this potential groundbreaking therapy for food allergic patients, as we are now well underway with both of our core clinical programs,” said Daniel Tassé CEO, DBV Technologies. “We believe the data generated through the COMFORT Toddlers study will complete the data set necessary for a Biologics License Application submission to the FDA. DBV is committed to advancing the development of Viaskin Peanut. Our patients and their families are counting on us.”
The data generated from COMFORT Toddlers will support the submission of a BLA anticipated in 2H 2026 under the Accelerated Approval Pathway, as previously agreed to with FDA.
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, Wednesday, June 25th, at 5:00pm EDT, to discuss these updates. This call is accessible via the teleconferencing numbers below and requesting the DBV Technologies call.
- United States: +1-877-346-6112
- International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-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.
Forward Looking Statements
This press release may contain forward-looking statements and estimates, 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, 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 French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-Q for the year ended March 31, 2025, filed with the SEC on April 30, 2025, and future filings and reports made with the AMF and 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.
Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies.
Investor Contact
Katie Matthews
DBV Technologies
katie.matthews@dbv-technologies.com
Media Contact
Brett Whelan
DBV Technologies
brett.whelan@dbv-technologies.com
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