DBV Technologies are making good progress in the development of their skin-patch peanut allergy therapy product Viaskin Peanut. The patch is designed to deliver biologically active compounds to the immune system through the skin. Phase III trials are currently underway in peanut-allergic children four to 11 years of age.
Results of recent Viaskin Peanut trials were presented at the recent 2017 American Academy of Allergy, Asthma & Immunology (AAAAI) meeting in Atlanta USA, with eight abstracts accepted for presentation at the meeting. The effect of Viaskin Peanut for children has been shown to be sustained or increased with continued treatment over three years. Adherence to the treatment was over 97% in all groups, while the safety profile of the treatment was also favourable. Over 80% of children participating in the trials responded to Viaskin Peanut after three years with no serious adverse events (SAEs) related to the treatment.
Phase III trials are now underway. One trial, called PEPITES (Peanut EPIT Efficacy and Safety Study) is a global double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of Viaskin Peanut in children aged four to 11 years. During PEPITES, patients’ response to peanut protein will be assessed using a double-blind, placebo controlled food challenge. Patients are randomly grouped to receive either Viaskin Peanut or placebo for 12 months.
A further Phase III study, ‘REALISE’ (REAL Life Use and Safety of EPIT) is a randomised, double-blind, placebo-controlled designed to assess the use of Viaskin Peanut in routine medical practice and generate safety data after six months of blinded treatment in patients four to 11 years of age. The study is being conducted in 32 centres in North America.
Topline results from the REALISE trial as well as the PEPITES trial, the company’s pivotal Phase III safety and efficacy trial, are expected in the second half of 2017
Following the completion of the current trials, all patients will be able to enter the PEOPLE trial which will be a long-term, open-label extension study of Viaskin Peanut.