Breakthrough Clinical Results
DBV Technologies announced the first subject has been screened in its COMFORT Toddlers study, a Phase 3 supplemental safety study evaluating the Viaskin Peanut patch in peanut-allergic children aged 1-3 years. The study will enroll approximately 480 subjects across numerous sites in the U.S., Canada, Australia, the UK, and Europe. The data from this study, along with data from the completed EPITOPE study, will support a Biologics License Application (BLA) submission to the FDA in the second half of 2026 under the Accelerated Approval Pathway. The Viaskin Peanut patch uses epicutaneous immunotherapy (EPIT) to desensitize the immune system to peanut allergens.
Key Highlights
- First subject screened in the COMFORT Toddlers Phase 3 safety study of Viaskin Peanut patch for peanut allergy in toddlers (1-3 years old).
- Study will enroll approximately 480 subjects across multiple countries.
- Data will support a BLA submission to the FDA in 2H 2026 under the Accelerated Approval Pathway.
- Viaskin Peanut patch utilizes epicutaneous immunotherapy (EPIT) to desensitize the immune system.
Incidence and Prevalence
Epidemiology of Peanut Allergy: Incidence, Prevalence, and Demographics
Incidence and Prevalence in the United States
Peanut allergy is the most common food allergy among children. According to US health care claims data analyzed between January 2011 and December 2017, the annual incidence of peanut allergy increased from 1.7% to 5.2% between 2001 and 2017. The estimated prevalence in 4- to 17-year-olds in the United States was 1.25 million (2.2%) in 2017. In the broader population, peanut allergy affects approximately 0.6% of the population in the United States.
Severity and Healthcare Utilization
Peanut allergy is considered the most serious of the hypersensitivity reactions to foods due to its persistence and high risk of severe anaphylaxis. Severe reactions (≥1) were observed in more than half (n = 399,806) of the patients, and 37.9% were triggered by an accidental exposure. One in 5 patients (n = 144,883) visited the emergency department due to peanut exposure. The data indicates that estimated severe reaction rates and health care utilization were high, suggesting that the burden of peanut allergy may be considerable.
Comorbidities
Atopic comorbidities were common among peanut-allergic patients, with asthma (60.8%), atopic dermatitis (61.7%), and other food allergies (35.3%).
Age-Related Patterns
A Swedish study found that IgE antibody levels during follow-up was related to age; subjects 0-6 years at initial test occasion were more likely to have higher IgE antibody class than older individuals. The Swedish study also showed that subjects over 6 years of age showed a decrease in peanut-specific IgE class over a 5-year period.
Trends
Claims data suggest that the incidence and prevalence of peanut allergy in the United States may be increasing.
Study Design Parameters
Peanut Allergy Study Design Parameters and Endpoints
Mouse Models and Endpoints
Research on peanut allergy has utilized several mouse models, particularly C3H/HeJ mice. These models employed different sensitization approaches: - Single intragastric administration of whole peanut (80 mg) without adjuvant - Oral sensitization with freshly ground whole peanut using cholera toxin as adjuvant
Challenge methods in these mouse studies included: - Intraperitoneal challenge with peanut extract two weeks after sensitization - Oral challenge with crude peanut extract at 3 and 5 weeks after sensitization - Systemic injection of high-dose peanut allergen extract
The endpoints measured in mouse studies were comprehensive: - Anaphylactic reactions assessed through:
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Vascular leakage
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Clinical symptoms severity
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Body temperature drops
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Breathing rate decreases
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Serum mouse mast cell protease-1 concentrations
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Sensitization confirmed via:
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Positive skin tests (ear swelling test and intradermal skin testing)
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Peanut-specific IgE levels
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Immunologic responses evaluated by:
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T-cell responses to Ara h 1 and Ara h 2 via splenocyte proliferative responses
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B-cell responses through antibody concentrations
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IgE antibody binding to Ara h 2 isoforms and allergenic epitopes
Human Clinical Trials
A systematic review of peanut immunotherapy (PIT) clinical trials from 2019 to 2021 analyzed 19 trials involving 1565 participants. These trials investigated various immunotherapy approaches: - Oral immunotherapy (OIT): 12 trials - Sublingual immunotherapy (SLIT): 2 trials - Subcutaneous immunotherapy (SCIT): 2 trials - Epicutaneous immunotherapy (EPIT): 2 trials - Comparison of SLIT and OIT: 1 trial
Primary Endpoints in Human Trials
The effectiveness of these therapies was primarily measured through desensitization rates: - 74.3% for OIT - 11% for SLIT - 61% for SCIT - 49% for EPIT
Safety assessments were crucial endpoints that included: - Frequency and severity of adverse events (AE) - Instances requiring epinephrine use - Classification of AEs as mild, moderate, or severe
Novel Approaches
Research has also explored passive immunotherapy (PIT) using: - Fully human recombinant anti-peanut IgG monoclonal antibodies (mAbs) - Anti-Ara h 2-specific IgG1 or IgG4 mAbs cocktails
Protection assessment in these novel approaches included: - Dose-dependent reduction of anaphylactic reactions - Complete protection observed at doses of approximately 0.3-0.6 mg mAbs - Effectiveness of mAb mixtures versus single mAbs - Comparison of IgG1 and IgG4 subclasses
Drug used in other indications
Viaskin Peanut Patch Clinical Indications Beyond Peanut Allergy
Based on the available information, there is no data regarding the use of Viaskin Peanut patch for indications other than peanut allergy. The current information exclusively focuses on the application of Viaskin Peanut patch for treating peanut allergy specifically.
Similarly, there is no information available about intervention models, dosing regimens, or administration protocols for Viaskin Peanut in non-peanut allergy indications, as no such trials appear to be documented in the provided context.