MONTROUGE, France—Peanut exposure can be dangerous and even fatal for allergic children, even in very small amounts. DBV Technologies has developed a new delivery system for the introduction of therapeutic agents to a patient’s immune system through intact skin, Viaskin Peanut, to try and address this allergy.
Viaskin, an investigational proprietary technology platform with broad potential applications in immunotherapy, is based on epicutaneous immunotherapy, or EPIT, DBV’s method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the company is dedicated to safely transforming the care of food-allergic patients for whom there are no approved treatments.
DBV has now completed a three-year study of Viaskin Peanut, the longest peanut allergy immunotherapy trial ever held, according to the company. The study, known as PEOPLE Phase 3 Open-Label Extension Study (PEPITES), involved children ages 4 to 11 who had been diagnosed by their doctors as peanut allergic. The subjects were divided between an experimental group that received Viaskin Peanut 250 µg and a control group given a placebo. The initial eliciting dose (ED), or challenge, of peanut protein was 1 mg, which rose gradually to 2,000 mg by the end of the study. These food challenges were given 30 minutes exposure until objective symptoms appeared.
According to Dr. David Fleischer, principal investigator of PEPITES and PEOPLE, as well as director of the Allergy and Immunology Center at Children’s Hospital Colorado, “These new long-term data support the overall clinical benefit of Viaskin Peanut that we’ve observed to date in Phase 2 and 3 clinical trials. We are particularly pleased to see that approximately three out of four patients showed an increase in their eliciting dose over three years, regardless of their individual baseline, with roughly 1 in 7 patients able to consume 5,444 mg peanut protein without reacting during the Month 36 oral food challenge.
“Most peanut-allergic children react to a single peanut (300 mg of peanut protein) or less, with some reacting to as little as 1 mg, leading many children and families to experience constant fear of accidental exposure, loss of normalcy and decreased quality of life. These new data provide further evidence that Viaskin Peanut may reduce the risk of reaction from accidental exposure by increasing threshold reactivity through a treatment option that could be safe and convenient.”
During the study, there were only six cases of reaction for which epinephrine had to be used to support the subject. At the end of one year, there was a significant difference in tolerance to increasing amounts of peanut challenge between the Viaskin Peanut group and the control group.
“Harnessing the important immune properties of the skin, epicutaneous immunotherapy represents a potentially unique mechanism of action that may support the sustained desensitization observed in this study even after a period without treatment,” explained Dr. Pharis Mohideen, chief medical officer of DBV Technologies. “These data further advance our understanding of the profile of Viaskin Peanut, which is currently under review by the U.S. Food and Drug Administration and may offer a simple, once-daily, non-invasive treatment option for children living with peanut allergy in the second half of 2020, if approved. Importantly, we would like to thank the children, families and investigators for participating in this study, the largest long-term trial in this underserved disease.”
By the end of the study, 75.9 percent of the patients increased their ED from baseline, demonstrating long-term clinical benefit and the potential for decreasing the chance of reacting to an accidental peanut exposure. About 1 in 7 patients were able to consume 5,444 mg peanut protein without symptoms during the Month 36 double-blind, placebo-controlled food challenge (DBPCFC). After 36 months, 51.8 percent (73/141) of patients reached an ED of at least 1,000 mg peanut protein, an increase relative to Month 12's number of 40.4 percent (57/141). Exploratory analyses suggest Viaskin Peanut may offer sustained efficacy even after a period without treatment. The analysis showed that 77.8 percent (14/18) of the children who completed the DBPCFC at Month 38 maintained desensitization with an ED ≥1,000 mg.
The safety profile of Viaskin Peanut was consistent with that observed in the clinical program in more than 1,000 patients. The most common adverse events were mild to moderate skin reactions localized to the administration site. There were low discontinuations due to adverse events.