French biopharmaceutical firm DBV Technologies has started patient enrolment in a Phase III EPITOPE clinical trial of Viaskin Peanut to treat peanut allergy in young children.
Viaskin Peanut is an immunotherapeutic candidate based on the firm’s epicutaneous immunotherapy (EPIT) designed to deliver biologically active compounds via the skin into the immune system.
The two-part, double-blind, placebo-controlled Phase III trial will assess the safety and efficacy of the investigational candidate in a total of up to 331 subjects aged between one and three at 20-40 clinical sites in Canada, the US, Ireland and Australia.
DBV Technologies chief scientific officer Dr Hugh Sampson said: "With results from our ongoing Phase III trial of Viaskin Peanut in peanut-allergic children four to 11 years of age expected later this year, the launch of EPITOPE, our second Viaskin Peanut Phase III programme, highlights our commitment to accelerating innovation in the field of food allergies.
"Recent studies in the field suggest that treating patients from a younger age may lead to significant therapeutic benefit, and Viaskin may be able to offer a safe, effective and convenient treatment for these younger children."
The first part of the trial will investigate the safety of 100µg and 250µg Viaskin Peanut over three months in around 50 subjects to determine the highest safety dose.
Designed to recruit about 281 additional subjects, the trial’s second part will evaluate the safety and efficacy of the determined safety dose over a 12-month period.
The trial’s primary efficacy endpoint will be a responder analysis following 12 months of treatment with Viaskin Peanut, while a double-blind, placebo-controlled food challenge (DBPCFC) will be used to monitor the efficacy.
Image: New Phase III trial for peanut allergy. Photo: courtesy of Aleksandar Cocek/flickr.