(BFM Bourse) – Food Allergy Biotechnology was able to demonstrate the effectiveness of its peanut desensitizing patch in very young children, where in 2017 a Phase 3 trial for the older age group failed. As part of a key new study leading up to the final approval of its flagship product, DBV is exploring regulatory mechanisms to offer treatment to children aged 1 to 3 who need medical attention most urgently.
It’s all about the confidence interval. In October 2017, French biotech star DBV Technologies hoped to quickly bring to market its first product, Viaskin Peanut, a peanut desensitization patch, based on the results of the Phase 3 PEPITES study in a population aged 4 to 11 years. In 35.5% of young patients who received effective treatment, a positive therapeutic response was positive, compared with 13.6% of patients who received placebo (a patch without the active ingredient), but the main endpoint, which assessed the confidence interval (CI) at the level The 95% difference in response rates between the active group and placebo did not reach – within two or three patients – the lower limit set by the FDA of 15% CI of the confidence interval.
At the time, this hitch caused DBV Technologies’ price to drop 45% in a single session. Unfortunately, a prelude to a series of disappointments and delays that, in total, led to the disappearance of 97% of the assessment compared to its historical peak.
Tuesday’s post-market announcement of the results of EPITOPE, a study of younger peanut allergy patients (ages 1 to 3), brings new hope to investors: DBV shares rose 18.1% at €3.38. This time, the superiority of the patch over placebo was demonstrated with a confidence interval well above the fatal limit of 15%.
Conducted on an even larger number of patients (414 compared to 356 in the previous study called PEPITES), EPITOPE (EPIT in infants with peanut allergy) assessed the safety and efficacy of Viaskin Peanut for the treatment of these very young children. Daily use of Viaskin Peanut demonstrated a statistically significant therapeutic effect: 67% of subjects in the 250 mcg active dose group reached endpoints after 12 months of therapy compared with 33.5% of subjects in the placebo group. Either a difference of 33.4% between the response rates of the two groups, or a range of 22.4% to 44.5% at 95% CI, therefore well above the 15% threshold.
In addition, the safety results generally confirmed the known safety profile of Viaskin Peanut observed in previous clinical studies conducted in children aged 4 years and older with peanut allergy. During the study, no imbalance was observed in the overall incidence of adverse events (AEs) between the active treatment group and the placebo group.
As of late December 2021, DBV Technologies has made the decision to relaunch a new baseline study for children 4 years of age and older, a primary target in terms of patient numbers, on a modified version of its patch (mVP) based on requests. from a US agency. The company is currently in productive dialogue with the Food and Drug Administration about the design of this trial, which should be called SPEED.
However, given the initial results of the EPITOPE study, the company will further analyze the data and explore ways to regulate Viaskin Peanut in children aged 1-3 years given the high unmet need and lack of approved treatment for this vulnerable population. Indeed, “most children are diagnosed with peanut allergy between the ages of 1 and 3, however there are currently no FDA-approved treatments for this age group. Many seem to confirm the benefits of treatment from an early age,” explained Dr. Hugh. Sampson, professor of pediatrics Kurt Hirschhorn of the Icahn School of Medicine at Mount Sinai, director emeritus of the Institute of Food Allergy. Jaffe and Chairman of the Scientific Council: “We believe these positive results support the clinical benefit of Viaskin Peanut in this important but underappreciated population.”
Going forward, DBV plans to present the full results of the EPITOPE study at future medical conferences and submit them for publication in a peer-reviewed journal. “The EPITOPE data improves our understanding of the ability of experimental cutaneous immunotherapy to induce an immune response with minimal allergens,” added Daniel Tasse, CEO of DBV Technologies. “These results further inform the potential of EPIT in other food allergies and immunological conditions; areas of research in which DBV continues to invest heavily.”
Guillaume Bair – © 2022 BFM Bourse