Date: 2016-02-25
Type of
information: Publication of results in a medical journal
phase: 1b
Announcement: publication of results in the Journal of Allergy and Clinical Immunology (JACI)
Company: DBV Technologies (France)
Product: Viaskin® Peanut
Action
mechanism: immunotherapy product. Viaskin® is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream. Viaskin® Peanut is currently being investigated in clinical trials for treatment of peanut allergy.
Disease: peanut allergy
Therapeutic
area: Allergic diseases - Immunological diseases
Country: USA
Trial
details: The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects. (NCT01170286)
Latest
news:
- • On February 25, 2016, DBV Technologies announced the publication of results from a Phase Ib trial showing that Viaskin® Peanut was observed to have a favorable safety and tolerability profile. High adherence to treatment, which was documented by an overall 96% compliance rate and a 4% dropout, was also observed. The publication is authored by Dr. Stacie Jones, Professor of Pediatrics at the University of Arkansas for Medical Sciences, Chief of Allergy and Immunology and Dr. and Mrs. Leeman King Chair in Pediatric Allergy at Arkansas Children's Hospital in Little Rock, and entitled “Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy: A Phase 1 Study Using Viaskin Patch” (Journal of Allergy and Clinical Immunology (JACI).
- The study, Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy, was completed in February 2012. Following this Phase Ib trial, DBV Technologies initiated VIPES , a dose-finding, Phase IIb clinical trial of Viaskin Peanut in peanut allergic patients, which met its primary endpoint in October 2014. DBV is currently studying Viaskin Peanut in PEPITES, a randomized, double-blind, placebo-controlled pivotal registration Phase III trial in patients 4 to 11 years of age.
- One hundred individuals between the ages of six and 50 were enrolled in this randomized, double-blind, placebo-controlled Phase Ib trial at five clinical sites in the United States. Peanut-allergic subjects were randomized 4:1 and treated for two weeks with Viaskin Peanut 20 µg, 100 µg 250 µg and 500 µg doses or placebo applied to intact skin at either 24 or 48 hour intervals. DSMB review occurred prior to progression of dosing at all stages.
- Detailed Results of the Phase Ib Clinical Study: No reports of serious adverse events (SAEs) or epinephrine use due to treatment occurred. Treatment emergent adverse events (TEAEs) were mostly mild and transient with no differences among treatment groups. No severe TEAEs were reported, and 47.5% of Viaskin Peanut treated subjects and 55% of placebo subjects reported no TEAE. The most commonly seen TEAEs were related to application site and included pruritus (itching), erythema (reddening), edema (swelling) and urticarial (hives). In this study, application of Viaskin Peanut for 24 hours demonstrated a more favorable safety and tolerability drug profile than the 48 hour application.
- The overall dropout rate was 4% (4/100). Of the four dropouts, three subjects were in the Viaskin Peanut arm and one subject was in the placebo group. More specifically:
- One adolescent treated with 500 µg Viaskin Peanut/48 hour was a consent withdrawal.
Two active-treatment patients treated with the 48-hour application (one child, 250 µg Viaskin Peanut/48-hours; one adult, 100 µg Viaskin Peanut/48-hour).
One adult patient, who only received placebo and experienced an anaphylactic reaction, was discontinued from the study for noncompliance upon investigator’s decision.
In this JACI publication, Dr. Jones and colleagues concluded that Epicutaneous Immunotherapy (EPIT®) administered via Viaskin was observed to have a favorable safety and tolerability profile, with high adherence by study participants.
Is
general: Yes
