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

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

Long-term Safety Results of Epicutaneous Immunotherapy (EPIT) with Viaskin Peanut in Peanut-Allergic Children Aged 4-11 Years in the Phase 3 PEOPLE Study (AAAAI 2024) - "Treatment-related TEAEs leading to epinephrine use occurred in 1/87 (1.1%) participants (Year 1 only). VP250 treatment over 5 years in PEOPLE showed decreasing frequency and severity of TEAEs, no new safety signals, and high treatment compliance. These data suggest long-term VP250 treatment in peanut-allergic children may have a favorable safety and tolerability profile, which may facilitate its use over multiple years of treatment."

Clinical • P3 data • Food Hypersensitivity

Safety and efficacy of epicutaneous immunotherapy with DBV712 (peanut patch) in peanut allergy. (PubMed, Expert Rev Clin Immunol) - "These findings, as well as supportive evidence from phase 2 studies, confirm the potential for an effective treatment of peanut allergy in children. The purpose of this review is to summarize the safety and efficacy of the peanut patch in the treatment of peanut allergy."

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 | Recruiting | Sponsor: DBV Technologies

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

Epicutaneous immunotherapy with Viaskin Peanut in toddlers: a plain language summary. (PubMed, Immunotherapy) - "These side effects happened less often and were less serious over the 12-month treatment period. Overall, these results show the peanut patch may be a possible treatment option to help desensitize young children with peanut allergy to peanut."

Journal • Review • Allergy • Food Hypersensitivity • Immunology

Efficacy and safety of peanut epicutaneous immunotherapy in patients with atopic comorbidities. (PubMed, J Allergy Clin Immunol Glob) - "As such, it is important to examine the safety and efficacy of epicutaneous immunotherapy with Viaskin Peanut 250 μg patch (VP250) in peanut-allergic children with these conditions...In subjects with concomitant food allergy at baseline, higher rates of treatment-emergent adverse events, but not study discontinuations or overall rates of anaphylaxis, were observed. The results support the safety and efficacy of VP250 for treating peanut-allergic children with or without concomitant atopic conditions."

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

DBV Technologies Outlines Regulatory Path for Viaskin Peanut in Children 1 – 3 Years After Receiving Pre-BLA Responses from FDA (GlobeNewswire) - "DBV Technologies...announced that DBV has received written responses from the U.S. Food and Drug Administration (FDA) on the regulatory path for investigational Viaskin™ Peanut 250 μg patch (DBV712) in toddlers ages 1 – 3 years-old with a confirmed peanut allergy. In February 2023, DBV submitted a pre-BLA Meeting request to FDA....The FDA did not request an additional efficacy study to support a future BLA but requires that DBV conduct an additional safety study in 1 – 3-year-olds using the original Viaskin Peanut patch to augment the safety data collected from the Phase 3 EPITOPE study.... DBV is engaging with the FDA on critical design elements of the new safety study and plans to submit a proposed safety study protocol to the FDA by the end of Q2 2023."

Clinical protocol • FDA event • Food Hypersensitivity

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Food Hypersensitivity • Immunology

Immune Response Evolution in Peanut Epicutaneous Immunotherapy for Peanut-Allergic Children. (PubMed, Allergy) - "Peanut sIgG4 rise most clearly differentiated Viaskin Peanut versus placebo subjects. sIgG4/sIgE ratios >20.1 and the combination of Ara h 1 and peanut sIgG4/sIgE had moderate ability to predict treatment response and could potentially be useful for clinical monitoring. Additional data are needed to confirm these relationships."

IO biomarker • Journal • 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 | Not yet recruiting | Sponsor: DBV Technologies

New P3 trial • Allergy • Food Hypersensitivity • Immunology

Efficacy and Safety of Epicutaneous Immunotherapy (EPIT) for Peanut Allergy in Subjects Aged 1-3 Years With and Without Atopic Dermatitis in the EPITOPE Study (AAAAI 2023) - "Rationale:In a Phase 3 double-blind, placebo-controlled clinical trial of 1-3-year-old peanut-allergic children (EPITOPE), EPIT with Viaskin Peanut 250 µg patch (VP250) reduced reactivity to peanut ingestion...Efficacy assessments were consistently in favor of VP250 vs placebo, irrespective of ongoing AD status at study entry. Safety assessments were similar between subjects with and without AD at study entry."

Clinical • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • 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 | Enrolling by invitation | Sponsor: DBV Technologies | Trial completion date: Jun 2023 ➔ May 2025

Trial completion date • Allergy • Food Hypersensitivity • Immunology

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers (GlobeNewswire) - "'Most peanut-allergic children are diagnosed between 1 to 3 years of age; however, there are currently no FDA-approved therapies for this age group. Furthermore, there is growing evidence on the benefits of treatment from a younger age,' said Dr. Hugh Sampson...'We believe these positive findings support the potential clinical benefit of Viaskin Peanut in this important, and underserved, population.'"

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