Three oral presentations highlighted analyses from the PEPITES Phase III study
- Three oral presentations highlighted analyses from the PEPITES Phase III study
- New data show that with Viaskin Peanut a majority of patients experience an increase in peanut threshold reactivity after the first 12 months of treatment (#A303)
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that three oral abstracts supporting the therapeutic potential of Viaskin Peanut were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2018 Annual Scientific Meeting in Seattle, Washington, November 15-19, 2018. The presentations included additional analyses from PEPITES, a pivotal Phase III efficacy and safety study of Viaskin Peanut in children ages four to 11. All abstracts are available online on the ACAAI Meeting website.
Dr. Hugh Sampson, Chief Scientific Officer of DBV Technologies and Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai said, “The breadth of data we shared with the scientific and medical community at ACAAI further illustrate the therapeutic benefit children may receive from treatment with Viaskin Peanut. From an analysis showing a robust overall patient desensitization to a quantitative model suggesting that patients treated with Viaskin Peanut in PEPITES may experience a meaningful reduction of the risks associated with accidental exposure, we are continuing to see important evidence supporting the potential use of Viaskin Peanut in the treatment of peanut allergy.”
In an oral presentation entitled, “Increased Reactivity Threshold in Peanut-Allergic Subjects Treated With 12 Months of Epicutaneous Viaskin Peanut” (#A303), Dr. Carla Davis, Texas Children’s Hospital, Houston, TX, presented findings showing that 62.6% of patients who were treated with Viaskin Peanut for 12 months in the PEPITES trial increased their peanut Eliciting Dose (ED), compared to 28.0% of patients in the placebo group. An odds ratio (OR) analysis indicated that patients treated with active therapy were 4.3 times more likely to improve their peanut threshold reactivity level versus placebo (OR = 4.3 (95% CI 2.7- 7.0), p<0.001). In the PEPITES study, Viaskin Peanut 250 μg was observed to demonstrate a statistically significant higher rate of responders over placebo after 12 months of treatment (difference in response rates = 21.7%; p=0.00001; 95% CI = 12.4% - 29.8%).
“Peanut allergy is a life-long, potentially life-threatening disease, which is currently affecting roughly two children in every US classroom. This significant unmet medical need impacts families daily, as the potential for accidental exposure to peanuts is pervasive: accidents can happen in restaurants, at school or even at home,” said Dr. Davis. “These new results from the PEPITES study, which investigated a potential first-in-class peanut desensitization therapy with the epicutaneous patch system, show that most patients treated with Viaskin Peanut are seeing an improvement in peanut reactivity after just the first year of treatment. This is an exciting time for the peanut allergy community as Viaskin Peanut continues to move toward a potential approval.”
Two additional oral presentations also highlighted analyses from the PEPITES study providing further understanding on the potential reduction of risks associated with accidental exposure to peanut, as well as data illustrating immunomodulatory changes that may be relevant when monitoring patients treated with Viaskin Peanut.
#A302: Quantitative Risk Reduction Through Epicutaneous Immunotherapy (EPIT): Results from the PEPITES Phase III Trial
Dr. Benjamin C. Remington, TNO, Ziest, The Netherlands, presented results from a quantitative risk analysis model showing that in this study, children treated with Viaskin Peanut for 12 months could potentially experience up to a 96.6% reduction of risk in developing an allergic reaction during accidental exposure to peanuts in various packaged food products. Children in the trial who were randomized to the placebo arm experienced a reduction of risk of only 2.5% to 2.9%. The main clinical implications from the study are that the risks of unexpected allergic reactions are drastically reduced for the treatment group after one year of EPIT with 250 μg of peanut protein.
#A305: Serum Biomarkers of Immunomodulation During Peanut Epicutaneous Immunotherapy (EPIT) in Peanut-allergic Subjects
Dr. Matthew Greenhawt, Children’s Hospital Colorado, Aurora, CO, presented additional analyses from the PEPITES Phase III trial further expanding on the immunomodulatory profile of Viaskin Peanut that exists to date. Significant changes in peanut-specific and peanut-component IgG4 levels were observed as early as in the first 3 months of treatment with Viaskin Peanut 250 μg (p<0.001). At month 6 and 12, significantly higher levels of peanut-specific IgG4 were observed with Viaskin Peanut 250 μg compared to placebo (p<0.001). These findings suggest that immunomodulatory effects start early during the treatment course and change in IgG4 levels may be important to monitor treatment progression with Viaskin Peanut.
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