Biopharmaceutical company DBV Technologies has announced positive results from its Viaskin® Peanut trial into reducing the risk of allergic reaction in children aged 4 to 11.
Viaskin is a patch applied directly to the surface of the skin and contains the allergenic peanut compound. The patch is able to activate the immune system, and long-term exposure to the peanut allergen through this patch may be able to promote sustained desensitisation to peanuts.
The results from the open-label extension of the Phase III PEPITES trial (PEOPLE) demonstrated long-term benefits including decreasing the chance of reacting to an accidental peanut exposure.
After three years, three quarters (75.9%) of patients had increased their dose from their baseline, with over half (51.8%) reaching a dose of at least 1,000 mg peanut protein by the third year.
“These new long-term data support the overall clinical benefit of Viaskin Peanut that we’ve observed to date in Phase II and III 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,” said Dr. David Fleischer, Principal Investigator of PEPITES and PEOPLE, Director, Allergy and Immunology Center and Section Head, Children’s Hospital Colorado.
“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.”
The PEOPLE study is an ongoing study evaluating the long-term safety, tolerability and efficacy of Viaskin Peanut in patients who have completed the Phase III PEPITES trial. Of the 213 patients, 198 opted to enter the PEOPLE study and of these, 148 were considered completers after 36 months, with 141 completing all treatment without major deviations.
The results from PEOPLE support the long-term tolerability and clinical benefit of Viaskin Peanut, demonstrating desensitisation over 36 months of treatment. During the study, the most common adverse events were mild to moderate skin reactions localised to the administration site and no serious adverse events were reported.
Analysis suggests Viaskin Peanut may offer a sustained effect even after a period without treatment. Participants who reached 1000mg at 36 months were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A food challenge was administered at the end of this period and results showed 77.8% maintain desensitisation with 1000 mg.
“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. 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,” said Dr. Paris Mohideen, Chief Medical Officer of DBV Technologies.
“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.”
Lynne Regent, Chief Executive of the Anaphylaxis Campaign, said, “We are pleased to hear the positive results of this study and we hope this is another step towards a safer future for people with allergies. Trials such as the PEOPLE study are crucial to developing possible treatments and help build confidence for people living with the risk of a severe allergic reaction.”
Viaskin® Peanut is currently under review by the U.S. Food and Drug Administration.
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