Viaskin Peanut (DBV 712) / DBV Technologies - LARVOL DELTA

Safety Study of Viaskin Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) (clinicaltrials.gov) - P3 | N=480 | Active, not recruiting | Sponsor: DBV Technologies | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergy • Food Hypersensitivity • Immunology

VIASKIN Peanut: New Clinical Data and Regulatory Pathway (EAACI 2026) - "Sponsored by DBV Technologies - DBV Technologies."

Clinical data • Allergy • Food Hypersensitivity • Immunology

Phase 2, Open-Label Study to Assess Consumption of Peanut in Infants Aged 6-12 Months With Peanut Allergy Treated With Epicutaneous Peanut Immunotherapy (EAACI 2026) - "Epicutaneous immunotherapy (EPIT) with the VIASKIN ® peanut patch containing 250 µg of peanut protein (VP250) is being investigated as a potential treatment option to desensitize peanut-allergic children and reduce the risk of reaction to accidental ingestion...Safety assessments will focus on adverse events (local and systemic), including serious adverse events and those leading to epinephrine use, as well as atopic dermatitis severity. Efficacy outcomes will be reported descriptively with 95% confidence intervals. Conclusion Results are expected to inform future immunotherapy protocols and may guide clinical practice while supporting VP250 (if approved) as a potential treatment option for infants with peanut allergy."

Clinical • P2 data • Allergy • Atopic Dermatitis • Dermatitis • Food Hypersensitivity • Immunology

VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children Aged 4-7 Years With Atopic Comorbidities (EAACI 2026) - "Background Epicutaneous immunotherapy (EPIT) with the VIASKIN peanut patch containing 250 µg peanut protein (VP250) has recently been shown to be superior to placebo in desensitizing children aged 4-7 years with peanut allergy in the VITESSE study...The response rates across treatment groups (VP250 vs placebo) were as follows; for participants with asthma: 48.3% vs 19.6% (risk difference: 28.8, 95% confidence interval [CI]:15.79, 41.76); food allergies: 46.8% vs 13.6% (risk difference: 33.2, 95% CI: 23.50, 42.83), and atopic dermatitis: 47.2% vs 13.2% (risk difference: 34.0, 95% CI: 25.09, 42.94). Conclusion VP250 demonstrated statistically significant efficacy across subgroups of children with peanut allergy and other common atopic comorbidities."

Clinical • P3 data • Atopic Dermatitis • Dermatitis • Food Hypersensitivity • Immunology

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: DBV Technologies

Trial initiation date • Allergy • Food Hypersensitivity • Immunology

Deriving Health Utilities from the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF) Using Mapping and Discrete Choice Experiments. (PubMed, Patient Relat Outcome Meas) - "The utilities derived from the mapping and DCE methods were applied to clinical trial data (PEPITES and PEOPLE) for an epicutaneous peanut patch (DBV712)...The DCE-derived health utilities showed greater sensitivity to changes in HRQoL. These utilities can be used in health technology assessments to better capture the impact of peanut allergy treatments on children's quality of life."

HEOR • Journal • Allergy • Food Hypersensitivity • Immunology • Mood Disorders • Psychiatry • NDRG1

Long-Term Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: EPOPEX End of Study Results (ACAAI 2025) - "Abstract Introduction In the phase 3 EPITOPE study of epicutaneous immunotherapy with the VIASKIN peanut patch (VP250), 67% of peanut-allergic toddlers were treatment responders (vs 33.5% placebo) after 1 year...Conclusions Three years of VP250 in 1- 3-year-old peanut-allergic toddlers resulted in continued accumulated treatment benefit without any new safety signals among those initially randomized to placebo in EPITOPE. These results are consistent with outcomes observed after 36 months in VP250-treated EPITOPE participants."

Clinical • Late-breaking abstract • Food Hypersensitivity

Safety Study of Viaskin® Peanut Patch in Peanut-allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: DBV Technologies | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Food Hypersensitivity • Immunology

PEPITES: Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy (clinicaltrials.gov) - P3 | N=500 | Completed | Sponsor: DBV Technologies | N=356 ➔ 500

Enrollment change • Allergy • Food Hypersensitivity • Immunology

Real-World Protective Effects of Epicutaneous Immunotherapy in Peanut-allergic Toddlers (EAACI 2025) - "Conclusion EPIT with VP has demonstrated reduced rates of APC-related reactions with further reductions observed as time on treatment and ED increase. These results suggest the potential of the VIASKIN peanut patch, if approved, to provide real-world effectiveness, including mitigating accidental peanut consumption reactions."

Clinical • Real-world • Real-world evidence • Food Hypersensitivity • Immunology

EPOPEX: Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children (clinicaltrials.gov) - P3 | N=304 | Completed | Sponsor: DBV Technologies | Active, not recruiting ➔ Completed

Trial completion • Allergy • Food Hypersensitivity • Immunology

Safety Study of Viaskin® Peanut Patch in Peanut-allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) (clinicaltrials.gov) - P3 | N=480 | Not yet recruiting | Sponsor: DBV Technologies

New P3 trial • Allergy • Food Hypersensitivity • Immunology

Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic Children with Atopic Comorbidities. (PubMed, Ann Allergy Asthma Immunol) - "The results suggest that 12 months of treatment with VP250 was effective in desensitizing peanut-allergic children aged 1 through 3 years, with no difference in efficacy and a favorable safety profile, regardless of the presence of atopic comorbidities."

Journal • Allergy • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Pulmonary Disease • Respiratory Diseases

DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved (GlobeNewswire) - "DBV Technologies...today announced a financing of up to $306.9 million (€284.5 million), including gross proceeds of $125.5 million (€116.3 million) to be received upon closing and an aggregate of up to ($181.4 million) (€168.2 million) in gross proceeds if all the warrants are exercised, subject to satisfaction of specified conditions....DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application ('BLA') and, to finance the readiness of a launch of Viaskin peanut in the US, if approved."

Financing • Food Hypersensitivity

DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results… (GlobeNewswire) - "VITESSE topline results on-track for the fourth quarter of 2025....DBV Technologies...today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group....Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval."

FDA event • FDA filing • Launch US • P3 data: top line • Food Hypersensitivity

Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study). (PubMed, J Allergy Clin Immunol Pract) - P3 | "Consistent with previous phase 3 studies, long-term EPIT with VP250 was well tolerated with high adherence in peanut-allergic children aged 4 through 11 years (clinicaltrials.gov; NCT: NCT02916446)."

Clinical • Journal • Allergy • Food Hypersensitivity • Immunology

Long-Term Efficacy Results of Epicutaneous Immunotherapy With VIASKIN® Peanut Patch in Peanut-Allergic Children Aged 4-11 Years in the Phase 3 PEOPLE Study (AAAAI-WAO 2025) - "Overall mean treatment compliance remained high (93%) out to 5 years. Conclusions Data suggest long-term VP250 treatment in peanut-allergic children who initiate treatment from age 4-11 years may lead to a continued accumulation of clinical benefit with high treatment compliance."

Clinical • P3 data • Food Hypersensitivity

DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study (GlobeNewswire) - P3 | N=330 | EPOPEX (NCT03859700) | Sponsor: DBV Technologies | "DBV Technologies...today announced positive twenty-four month results from its Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of VIASKIN peanut 250 µg [VP250] in toddlers ages 1 to 3 years). The data provide support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters....In the EPITOPE OLE, VIASKIN Peanut data suggests further improvement through 36 months of treatment across all efficacy parameters. Key data highlights include: 266 EPITOPE participants enrolled in the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62 placebo). After three years of VP250, 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study)."

P3 data • Food Hypersensitivity

EPITOPE: Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (clinicaltrials.gov) - P3 | N=414 | Completed | Sponsor: DBV Technologies | Active, not recruiting ➔ Completed

Trial completion • Allergy • Food Hypersensitivity • Immunology

EPOPEX: Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children (clinicaltrials.gov) - P3 | N=330 | Active, not recruiting | Sponsor: DBV Technologies | Enrolling by invitation ➔ Active, not recruiting | Trial primary completion date: Jun 2023 ➔ May 2025

Enrollment closed • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Epicutaneous immunotherapy for the treatment of peanut allergy. (PubMed, Allergy) - "Numerous clinical studies of Viaskin Peanut have demonstrated desensitization and reductions in reaction severity, particularly in children aged 1 through 11 years, as well as a favorable safety profile with mostly mild-to-moderate skin reactions that were observed to decrease over time. EPIT with Viaskin Peanut may be a potential therapeutic option for peanut allergy that is clinically practical with long-term efficacy and tolerability."

Journal • Review • Allergy • Food Hypersensitivity • Immunology

VITESSE: Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: DBV Technologies | Recruiting ➔ Active, not recruiting | Trial completion date: May 2029 ➔ Oct 2029 | Trial primary completion date: Sep 2026 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

VITESSE: Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: DBV Technologies | Trial completion date: Mar 2025 ➔ May 2029 | Trial primary completion date: Mar 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Reactions Due to Accidental Peanut Consumption During Epicutaneous Immunotherapy for Peanut Allergy in Toddlers (EAACI 2024) - "No increase in APC events was observed during the OLE period, suggesting participants were not more likely to engage in risk-taking behavior on active treatment. These results show that Viaskin Peanut may offer real-world protection from reactions due to APC, with increased clinical benefit over time."

Allergy • Food Hypersensitivity • Immunology

A Streamlined Approach to Basophil Activation Testing for Longitudinal Characterization of Toddlers with Peanut Allergy During a Multi-Site Phase 3 Double-Blind Placebo-Controlled Trial of Epicutaneous Immunotherapy (EPIT) (AAAAI 2024) - "Methods Whole blood samples were collected from subjects aged 1-3 years (n=129) recruited across 15 different clinical sites conducting a trial of EPIT with Viaskin Peanut...Conclusions sBAT can be easily implemented with shipped samples up to 5 days old in multicenter studies. It contributes to the prediction of DBPCFC outcomes and demonstrates immunomodulatory effects from EPIT, which may help our understanding of the treatment and risk stratification of peanut allergy."

Clinical • IO biomarker • Late-breaking abstract • P3 data • Allergy • Food Hypersensitivity • Immunology • CD63