DBV Technologies Announces Publication of Detailed Phase III Trial Results Evaluating Viaskin Peanut as a Novel Treatment for Peanut Allergy in The Journal of the American Medical Association

DBV Technologies Announces Publication of Detailed Phase III Trial Results Evaluating Viaskin Peanut as a Novel Treatment for Peanut Allergy in The Journal of the American Medical Association.

Viaskin Peanut is the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system and induce desensitization in peanut-allergic children

Significant difference in responder rates between Viaskin Peanut and placebo (p<0.001) suggests that treated patients are less likely to have allergic reactions due to accidental exposures to peanut

According to a post-hoc analysis, 62.6% of patients receiving Viaskin Peanut showed an increase in their eliciting dose at 12 months of treatment

Low discontinuation rates in the Viaskin Peanut arm due to treatment-emergent adverse events (1.7%) were experienced in the trial

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that detailed results from its pivotal Phase III clinical trial evaluating the efficacy and safety of Viaskin Peanut for the treatment of peanut-allergic children 4 to 11 years of age were published in TheJournal of the American Medical Association (JAMA).

Data from the Phase III PEPITES1 (Peanut EPITEfficacy and Safety) study show that Viaskin Peanut (250 µg) administered once-daily on the skin as a non-invasive patch demonstrated clinically meaningful desensitization in peanut-allergic children, suggesting patients who were treated with active therapy may be less likely to have an allergic reaction to an accidental exposure to peanut as compared to placebo. Viaskin Peanut was observed to be well-tolerated in the trial, resulting in a low discontinuation rate due to treatment-emergent adverse events (TEAEs).

"My peanut-allergic patients and their families face the daily fear of accidental peanut exposure resulting in a possible life-threatening reaction, and desperately seek a well-tolerated treatment that does not add even more restrictions to their everyday lives," said Dr. David Fleischer, Director, Allergy and Immunology Center and Associate Section Head, Children's Hospital Colorado, and lead author of the publication. "The efficacy and safety data published in JAMA support Viaskin Peanut as a convenient and well-tolerated potential therapeutic option that may provide clinically meaningful benefit for these patients and families without imposing a major treatment burden."

Viaskin Peanut is an investigational treatment that has been studied in over 775 patients worldwide as part of a global registrational program. The PEPITES trial is the largest randomized controlled efficacy and safety study ever completed using epicutaneous immunotherapy (EPIT) to treat peanut allergy, a potentially life-threatening disease with no FDA-approved treatment options. The study randomized 356 children ages 4 to 11 years with a physician-diagnosed peanut allergy who had an eliciting dose (ED) of ≤300 mg peanut protein (about one peanut) during a double-blind, placebo-controlled food challenge (DBPCFC). During the 12-month trial, patients did not have required restrictions from physical activity while wearing Viaskin Peanut or during concomitant illness.

PEPITES Efficacy Results
Data from the PEPITES trial demonstrates that after 12 months of treatment, a statistically significant greater proportion of patients treated with Viaskin Peanut had an increase in the amount of peanut protein required to elicit an allergic reaction during the food challenge compared with placebo (treatment difference = 21.7%; 95% CI = 12.4% - 29.8%; p<0.001):

An increase in the cumulative reactive dose (CRD), a key secondary endpoint measuring threshold reactivity, was observed between Viaskin Peanut and placebo (nominal p-value<0.001).

Exploratory analyses showed that changes in peanut-specific biomarkers, including immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), support the immunomodulatory effect with Viaskin Peanut.

In a post-hoc analysis, the majority of patients on Viaskin Peanut experienced an increased ED compared with the placebo group (62.6% in active vs. 28% in placebo) at 12 months.

An additional post-hoc analysis showed that 53.1% of patients treated with Viaskin Peanut increased their baseline ED from ≤100 mg to ≥300 mg, compared to 19% in the placebo group. Based on quantitative risk modeling, we believe this improvement in ED is predicted to reduce the risk of an allergic reaction due to accidental exposure by over 95%.

             
Although the difference in responder rates between patients receiving Viaskin Peanut versus placebo was statistically significant, the study did not meet a statistical component of its primary endpoint; the pre-specified 15% lower bound of the confidence interval between the treatment groups was not met, as the lower bound of the confidence interval was 12.4%.

PEPITES Safety and Tolerability Results
A favorable safety and tolerability profile was observed with Viaskin Peanut. Treatment adherence was high (98.5%), and similar discontinuation rates between treatment groups were reported, with 89.9% of patients completing the trial. There was a low discontinuation rate due to treatment-emergent adverse events (TEAEs) (1.7%), and the overall rate of TEAEs, regardless of relatedness to the treatment, was comparable between treatment and placebo groups, at 95.4% and 89.0%, respectively. The most commonly reported TEAEs were mild to moderate application-site reactions that decreased after Month 1 in both frequency and severity. No treatment-related gastrointestinal AEs were observed.

There were no cases of severe anaphylaxis in the trial. Serious AEs (SAEs) were balanced between the Viaskin Peanut and placebo group, at 4.2% vs. 5.1%, respectively. Four SAEs reported in three Viaskin Peanut patients (1.3%) were determined by the investigator as possibly or probably related to treatment. A low rate of treatment-related epinephrine use was reported (2.9% treatment group vs. 0.8% placebo group). Ten cases in eight Viaskin Peanut patients (3.4%) of possibly or probably treatment-related anaphylaxis occurred; all were classified as mild or moderate without evidence of cardiovascular, neurologic, or respiratory compromise. Six of these ten cases were treated with epinephrine, and five of the eight patients continued on Viaskin Peanut in the study.

"I would like to thank all of the investigators, patients, caregivers and staff who contributed to this important trial. We are pleased to see PEPITES published by such a prestigious journal," said Dr. Hugh Sampson, Chief Scientific Officer and interim Chief Medical Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai. "Viaskin Peanut is the first and only epicutaneous immunotherapy in development today for the treatment of peanut allergy. It aims to rebalance the immune system of peanut-allergic patients by exposing them once daily to only about one-one thousandth of a peanut kernel via a non-invasive patch. We expect to submit an updated Biologics License Application (BLA) for Viaskin Peanut in the third quarter of 2019, potentially bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families."

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