Date: 2015-06-08
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the 2015 European Academy of Allergy & Clinical Immunology (EAACI) Congress in Barcelona, Spain
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
Country:
Trial details:
Latest
news: * On June 8, 2015, DBV Technologies announced that it has presented and will present clinical and scientific data on EPIT® for the treatment of food allergies at the 2015 European Academy of Allergy & Clinical Immunology (EAACI) Congress in Barcelona, Spain, that is being held from June 6-10. Specifically, investigators conducting the company’s VIPES study presented additional post-hoc results from this Phase IIb trial for the treatment of peanut allergy, which showed that increasing the stringency of the responder definition led to a clear treatment doseresponse versus placebo in both the study’s population and in the children’s subgroup. New scientific data also supports the use of EPIT® in the treatment of food allergies versus oral (OIT) and sublingual (SLIT) immunotherapy. The company remains on track to start its Phase III trial in peanut allergic children, the PEPITES (Peanut
Clinical Data Highlights : Dr. Christophe Dupont from Necker hospital, Paris, France, and Dr. Hugh Sampson from the Mount
Sinai Hospital in New York, NY, USA presented results that continue to support the efficacy and safety profile of Viaskin® Peanut for the treatment of peanut allergy. Results of the company’s Phase IIb trial in peanut allergic patients, the VIPES study, were previously presented at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. In VIPES, 221 patients were randomized to Viaskin® Peanut doses of 50 μg, 100 μg, or 250 μg, or to placebo. The primary efficacy endpoint, measured after 12 months of treatment, was the proportion of responders with a peanut eliciting dose 10-fold greater than baseline or achievement of a post-treatment eliciting dose of at least 1,000 mg peanut protein. The primary efficacy endpoint was met at a dose of 250 μg, with 50.0% responders vs 25.0% with placebo, p=0.0108. Children in this arm (6-11 years) exhibited statistically significant efficacy with 53.6% responders vs 19.4% for placebo, p=0.0076. New data presented by Drs. Dupont and Sampson also emphasized Viaskin® Peanut’s clinical relevance and magnitude of treatment effect, which was observed in VIPES. A post-hoc analysis showed that increasing the stringency of the responder definition lead to a clear treatment dose response versus placebo in both the study’s population and in the children’s subgroup. Using the more stringent definition, results show that 50% of children were able to achieve a post-treatment eliciting dose of at least 300 mg of peanut protein after 12 months of treatment versus 12.9% in the placebo arm (p=0.0039). According to Dr. Dupont, in patients reacting to very low amount of peanut at baseline, the threshold dose of 300 mg peanut protein is clinically relevant as reaching this level significantly reduces the risk of allergic reactions against potential peanut traces in commercial processed foods.
