Slide 1: VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children
VITESSE Phase 3 Study: Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children 4 Through 7 Years of Age David M. Fleischer, Douglas P. Mack, Julie Wang, Jeffrey Leflein, Michael O’Sullivan, Anne-Sophie Chhim, Katharine J. Bee, Hugh A. Sampson
Slide 2: David M. Fleischer, MD
David M. Fleischer, MD Professor of Pediatrics Section Head, Allergy and Immunology Director, Allergy and Immunology Center University of Colorado School of Medicine Aurora, CO, USA Disclosures: Dr. Fleischer reports grants paid to the institution from DBV Technologies and ARS Pharmaceuticals; royal
Slide 3: Introduction: Epicutaneous Immunotherapy for Peanut Allergy
Introduction: Epicutaneous Immunotherapy for Peanut Allergy VIASKIN® peanut patch, a novel approach to epicutaneous immunotherapy VIASKIN® peanut patch (EPIT) for peanut allergy in children, involves the administration of a patch (VP250) to intact skin to induce desensitization1-5 VP250 contains 250
Slide 4: VITESSE Study Design: 12-Month Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial
VITESSE Study Design: 12-Month Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial1 DBPC period Open-label extension Phase 3 global trial (NCT05741476) • Peanut-allergic children SU assessment* (aged 4 through 7 years) VP250 VP250 • 87 sites in Australia, Canada, Randomized 2:1 Europe, and th
Slide 5: Participant Demographics and Baseline Characteristics Were Well Balanced Between Study Groups
Participant Demographics and Baseline Characteristics Were Well Balanced Between Study Groups VP250 Placebo (n=438) (n=216) Age, years, median (Q1, Q3) 5.7 (4.78, 6.88) 5.7 (4.84, 6.68) Gender, n (%) Male 265 (60.5) 142 (65.7) Female 172 (39.3) 74 (34.3) Undifferentiated 1 (0.2) 0 (0.0) Peanut-speci
Slide 6: VP250 Met the Primary Endpoint and Demonstrated Significantly Greater Responder Rates vs Placebo
VP250 Met the Primary Endpoint and Demonstrated Significantly Greater Responder Rates vs Placebo Treatment Responders* at Month 12 (ITT population) 50 p<0.0001† 45 46.6 40 35 Δ=31.8% Participants (%) 30 (95% CI: 24.52, 39.02) 25 20 15 10 14.8 5 0 VP250 Placebo (n=438) (n=216) *Responders were define
Slide 7: Sensitivity Analyses of the Primary Endpoint Demonstrate Consistency of Treatment Effect
Sensitivity Analyses of the Primary Endpoint Demonstrate Consistency of Treatment Effect Population Analysis Difference in Response Rate (95% CI) Responder Rate VP250 Placebo 46.6 Overall 31.8 (24.5, 39.0) 14.8 Missing = failure 41.9 imputation 28.8 (22.1, 35.4) 13.1 ITT Exclude subjects with 35.1 (
Slide 8: Significantly Greater Proportion of Treatment Responders Observed With VP250, Regardless of Baseline ED Strata
Significantly Greater Proportion of Treatment Responders Observed With VP250, Regardless of Baseline ED Strata Treatment Responders* at Month 12 by Baseline ED Strata (ITT population) 60 Baseline ED of ≤30 mg 60 Baseline ED of 100 mg p<0.0001 50 50 p<0.0001 49.3 Participants (%) 40 40 43.1 Δ=34.6% 3
Slide 9: The Majority of VP250 Participants Increased Their Eliciting Dose by at Least Two Doses
The Majority of VP250 Participants Increased Their Eliciting Dose by at Least Two Doses Changes in Eliciting Dose at Month 12* 100% 82.8% of VP250 participants 23.4% increased their ED, suggesting 80% response to treatment, vs 47.9% on placebo Participants (%) 60.1% 24.5% 60% ED increase (≥2 doses
Slide 10: Low Rates of Participants With Severe Treatment-Related Adverse Events
Low Rates of Participants With Severe Treatment-Related Adverse Events VP250 Placebo (n=438) (n=216) TEAEs, number of participants (%) Overall 432 (98.6) 207 (95.8) Mild 421 (96.1) 198 (91.7) The majority of TEAEs were Moderate 231 (52.7) 83 (38.4) mild local application-site Severe 5 (1.1) 6 (2.8)
Slide 11: Treatment With VP250 Was Well Tolerated
Treatment With VP250 Was Well Tolerated VP250 Placebo Overall (n=438) (n=216) (n=654) TEAEs leading to permanent study 14 (3.2) 1 (0.5) 15 (2.3) discontinuation, n (%) Mean compliance* (%) 96.1 96.5 96.2 The low rates of discontinuations due to TEAEs and high compliance suggest that VP250 was well t
Slide 12: Summary
Summary Efficacy results from VITESSE, the largest food allergy immunotherapy trial to date, demonstrated that EPIT with VP250 resulted in significantly greater responder rates vs placebo (46.6% vs 14.8%; p<0.0001) in a highly sensitized population of peanut-allergic children aged 4-7 years The safe