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Viaskin Peanut · 4 trials · 1 indication
The Double-Blind Placebo-Controlled Food Challenges (DBPCFCs) to determine Eliciting Dose (ED) were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: * ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or * ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis of the difference in response rates between treatment groups is presented in the subsequent statistical analysis table. Analysis was performed in the overall population.
A treatment responder was defined as a participant with a peanut protein eliciting dose (ED) equal to or greater than 1000 milligram (mg) peanut protein or with at least a 10-fold increase of the ED compared to their initial ED observed at the VIPES baseline, as determined by double-blind placebo-controlled food challenge (DBPCFC) at Months 12 and 24. At Month 12, participants had received 24 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 12 months of active treatment for those who received placebo in the VIPES study. At Month 24, participants had received 36 months of active treatment for those who received Viaskin Peanut in the VIPES study, and 24 months of active treatment for those who received placebo in the VIPES study. The percentage of responders at Month 12 and Month 24 are presented according to whether participants received Viaskin Peanut or placebo during the VIPES study.
A treatment responder was defined as a participant with a peanut protein eliciting dose equal to or greater than 1,000 mg peanut proteins based on the results of the DBPCFC after 12 months of treatment or a participant with a \>=10-fold increase of the eliciting dose at 12 months, compared to the initial eliciting dose. For participants with missing treatment response at Month 12, last observation carried forward (LOCF) imputation was used (i.e., participants were considered as non-responders).
| Arm | Type | Description |
|---|---|---|
| Viaskin Peanut 250 mcg | EXPERIMENTAL | Viaskin Peanut 250 mcg, daily administration |
| Placebo | PLACEBO_COMPARATOR | Placebo patch, daily administration |
| Viaskin Peanut 250mcg | EXPERIMENTAL | One Viaskin epicutaneous delivery system (patch) containing 250 µg of peanut protein applied on the skin for 24 hours (±4 hours of allowance) daily for a period of 12 months. |
| Viaskin Peanut 50 mcg | EXPERIMENTAL | - |
| Viaskin Peanut 100 mcg | EXPERIMENTAL | - |
| Viaskin Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Viaskin Peanut 250 mcg | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
| Viaskin Peanut 250mcg | BIOLOGICAL | Peanut extract cutaneous patch |
| Viaskin Peanut 50 mcg | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 50 mcg peanut proteins as whole peanut extract |
| Viaskin Peanut 100 mcg | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 100 mcg peanut proteins as whole peanut extract |
| Viaskin Placebo | BIOLOGICAL | Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing a matching placebo formulation |
Inclusion Criteria: * Physician-diagnosed peanut allergy; * A peanut Skin Prick Test (SPT) with a wheal largest diameter ≥8 mm; * A specific-peanut Immunoglobulin E (IgE) ≥14 kU/L; * Subjects following a strict peanut-free diet. Exclusion Criteria: * Generalized dermatologic disease * Spirometry ...
Viaskin Peanut is an investigational immunotherapy being developed for the treatment of peanut allergy. It is designed for use in adults and children with immunoglobulin E (IgE)-mediated peanut allergy. The drug is delivered through a skin patch and has been studied in clinical trials for its efficacy and safety in desensitizing patients to peanut allergens.
Viaskin Peanut is developed by DBV Technologies S.A., a biopharmaceutical company listed on the stock exchange under the ticker symbol DBVT. The company has conducted multiple clinical trials to evaluate the safety and efficacy of Viaskin Peanut in patients with peanut allergy.
Viaskin Peanut is in Phase 3 clinical development. It has completed four clinical trials, including two Phase 3 studies, with a total enrollment of 1,285 participants. The drug is investigational and has not been approved by regulatory authorities, though it has received accelerated approval designation from the FDA.
Viaskin Peanut has completed four clinical trials. These include NCT01675882 and NCT01955109, both Phase 2 studies in adults and children with peanut allergy, and NCT02636699 and NCT02916446, both Phase 3 studies. The trials were randomized, double-blind, and placebo-controlled, conducted in multiple countries including the United States, Canada, and European nations.
Viaskin Peanut is a monoclonal antibody-based immunotherapy delivered via a skin patch. It is designed to modulate the immune response to peanut allergens, aiming to reduce allergic reactions in patients with peanut allergy. The exact mechanism involves the delivery of peanut protein through the skin to induce immune tolerance.
Viaskin Peanut is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. The FDA has granted it accelerated approval designation, which may facilitate a faster review process, but the drug has not yet received marketing authorization.