Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Technical Presentation (February 2019)
24 slides from Dbv Technologies Sa's technical presentation, Feb 22, 2019
Slide 1: Epicutaneous immunotherapy in children with peanut allergy: the PEPITES trial
Investigational Epicutaneous immunotherapy in children with peanut allergy: the Peanut epit efficacy and safety (pepites) trial Presented by David Fleischer, MD and Hugh Sampson, MD Epicutaneous immunotherapy and Viaskin® Peanut are under clinical investigation and have not been approved for marketi
Slide 2: Introduction and disclosures - Hugh A. Sampson, MD
Introduction and disclosures Hugh A. Sampson, MD Kurt Hirschhorn Professor of Pediatrics Icahn School of Medicine at Mount Sinai New York, New York Disclosures: Chief Scientific Officer and Chief Medical Officer at DBV Technologies Consultant/Advisory Boards: N-Fold, LLC Ownership Interest: N-Fold,
Slide 3: Peanut Allergy is a Substantial Burden That Often Lasts a Lifetime
Peanut Allergy is a Substantial Burden That Often Lasts a Lifetime Many caregivers have expressed a need for a treatment that provides protection from reactions due to unintentional peanut exposures that may also improve their quality of life3 Many uncontrollable factors contribute to severity, maki
Slide 4: Investigational EPIT Using Viaskin Peanut induces desensitization through the skin
Investigational EPIT Using Viaskin® Peanut induces desensitization through the skin Condensation chamber Water loss and solubilization Solubilized antigen Langerhans cell EPIT activates the immune system following exposure to 250 µg of peanut protein to intact skin1 Condensation chamber formed by Vi
Slide 5: Clinical Investigation of Viaskin Peanut involves once-daily application
Clinical Investigation of Viaskin® Peanut involves once-daily application Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. *Per the clinical trial protocol, the first patch is applied for 3
Slide 6: Introduction and disclosures - David M. Fleischer, MD
Introduction and disclosures David M. Fleischer, MD Associate Section Head Director, Allergy and Immunology Center Associate Professor of Pediatrics Children’s Hospital Colorado University of Colorado School of Medicine Aurora, Colorado Disclosures: Grant/research support: DBV Technologies, Aimmune
Slide 7: PEPITES phase 3 trial results published in JAMA
Pepites phase 3 trial Results published in jama 1. Fleischer DM, et al. JAMA. 2019. doi:10.1001/jama.2019.1113. Epicutaneous immunotherapy and Viaskin® Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.
Slide 8: PEPITES assessed efficacy and safety of Viaskin Peanut in children after 12 months
PEPITES assessed efficacy and safety of Viaskin® peanut in children after 12 months of treatment M0 M12 Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. 356 children aged 4 to 11 years 31 st
Slide 9: Study participants representative of broad pediatric peanut allergy population
Study Participants representative of broad pediatric peanut allergy patient population Age: 4 to 11 years Physician-diagnosed peanut allergy Strict peanut-free diet Eliciting dose* ≤300 mg peanut protein Peanut-specific IgE >0.7 kUA/L Peanut SPT with largest wheal diameter: ≥6 mm for 4 to 5 years of
Slide 10: Trial measured a broad range of outcomes
trial measured a broad range of outcomes *Outcomes mentioned are not inclusive of all secondary and exploratory measures. †Including Grade 4 local cutaneous reactions and systemic allergic TEAEs considered to be treatment-related. AE=adverse event; CI=confidence interval; FDA=US Food and Drug Admini
Slide 11: Trial population included those with multiple allergic conditions
trial POPULATION included those with multiple allergic conditions 356 Patients Randomized, n (%) Active (VP250 μg): 238 (67%) Placebo: 118 (33%) Peanut Eliciting Dose (mg) Median: 100 Mean: 140 Age, years, median (Q1, Q3) Active: 7 (6,9) Placebo: 7 (5,9) Gender, n (%) Male: 218 (61.2%) Female: 138 (
Slide 12: Primary efficacy outcome showed statistically significant treatment benefit
primary efficacy outcome showed statistically significant treatment benefit After 12 months, a significantly larger percentage of participants responded to Viaskin® Peanut treatment vs placebo patch 35.3% vs 13.6% (P<0.001) The prespecified 15% lower bound of the 95% CI of the difference between tre
Slide 13: Cumulative reactive dose increased over months of treatment
cumulative reactive dose (crd) increased over 12 months of treatment1,2 A difference in CRD was observed between the active and placebo groups (P<0.001*) The median CRD in participants in the Viaskin® Peanut 250 µg group increased from 144 mg at baseline to 444 mg at Month 12 *Nominal P value. CI=co
Slide 14: Changes in biomarkers support immunomodulatory effect of Viaskin Peanut
Changes in biomarkers support immunomodulatory effect of Viaskin® peanut1,2 Levels of IgE increased initially then returned to baseline Treatment groups were distinguishable based on levels of peanut-specific IgG4 as early as month 3 Levels of IgG4 steadily increased in Viaskin Peanut subjects and w
Slide 15: Increased eliciting dose in majority of participants treated with Viaskin Peanut
Increased Eliciting Dose (ed) in majority of participants treated with Viaskin® peanut In a post-hoc analysis, 53.1% of subjects on Viaskin Peanut 250 µg increased their baseline ED from ≤100 mg to ≥300 mg, vs only 19% on placebo patch1 Based on risk assessment modeling, raising ED from ≤100 mg to ≥
Slide 16: High adherence and low discontinuation due to TEAEs
high adherence and low discontinuation due to TEAEs1,2 89.9% of all subjects completed the study, with similar discontinuation rates observed between treatment groups (10.5% in Viaskin® Peanut group, 9.3% in placebo group) Treatment adherence* was high (98.5%) across the total population, and compar
Slide 17: Low rates of treatment-related serious AEs
Low rates of treatment-related serious Aes Viaskin® Peanut 250 µg: 12 SAEs* in 10 participants (4.2%); Placebo: 6 SAEs in 6 participants (5.1%) 4 SAEs in 3 Viaskin Peanut participants considered related to treatment (1 probably related, 3 possibly related) All were moderate anaphylaxis without evide
Slide 18: Most commonly reported treatment-related TEAEs were local administration-site reactions
The most commonly reported treatment-related TEAEs were local administration-site reactions 95.4% of Viaskin® Peanut and 89.0% of placebo participants experienced TEAEs, mostly mild* or moderate, regardless of treatment relatedness† The majority of local treatment-related TEAEs were mild or moderate
Slide 19: Local skin reactions decreased in frequency and severity after month 1
Local skin reactions decreased in frequency and severity after month 11,2 Skin reactions were more frequent through month 1 of patch application, and decreased through month 12 in both frequency and severity 2 participants treated with Viaskin Peanut 250 µg discontinued the study due to application
Slide 20: Cases of anaphylaxis were mild or moderate with low rates of epinephrine use
*Two discontinuations were due to moderate anaphylaxis adverse events; the third participant had mild anaphylaxis, but did not discontinue until 4 days after the event with parental consent withdrawal. NIAID=National Institute of Allergy and Infectious Diseases. 1. Fleischer DM, et al. JAMA. 2019. d
Slide 21: Summary
summary In response to the need for improved treatment approaches in peanut allergy, epicutaneous immunotherapy (EPIT) is being investigated with the aim of inducing desensitization through intact skin Data from the pivotal Phase 3 study PEPITES, now published in JAMA, showed that patients treated w
Slide 22: Thank you
Thank you We would like to thank all the participants, caregivers, investigators, staff, and others who contributed to this important trial investigating the use of epicutaneous immunotherapy in children with peanut allergy
Slide 23: Phase 3 program to assess Viaskin Peanut in children
phase 3 program to assess Viaskin® peanut in children Participants in PEPITES were invited to enroll in the follow-up study (PEOPLE) 298 (92%) participants who completed PEPITES opted to enroll in PEOPLE and are being followed up for an additional 24 to 36 months In total, 775 patients have been tre
Slide 24: Our mission
Our mission Dedicated to Improving the Lives of Patients with Food Allergies and Other Immunological Diseases
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