DBV Technologies S.A. (NASDAQ: DBVT) shares jumped on Thursday after the firm announced positive topline results from its late-stage study in children with a peanut allergy. This study has been long awaited and, by the looks of it, will put Viaskin on the way to regulatory approval.
The results come from the Phase 3 Peptites (People) trial evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years.
Ultimately, the results demonstrated long-term clinical benefit, as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure. After three years, 75.9% of patients had increased their ED from baseline, and 51.8% of patients reached an ED of at least 1,000 mg peanut protein by year three.
The People study is an ongoing open-label extension study evaluating the long-term safety, tolerability and efficacy of Viaskin Peanut in patients who have completed the Phase 3 Peptites trial. Topline results from People support the long-term tolerability and clinical benefit of Viaskin Peanut, demonstrating desensitization over 36 months of treatment.
Dr. David Fleischer, principal investigator of Peptites and People, director of the Allergy and Immunology Center, and section head at Children’s Hospital Colorado, commented:
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. 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.
Shares of DBV Tech were last seen up about 16% at $13.03, in a 52-week range of $5.77 to $13.49. The consensus price target is $15.18.
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