Slide 1: A Phase 2, Open-Label Study to Assess Consumption of Peanut in Infants Aged 6-12 Months
Abstract ID: 001954 A Phase 2, Open-Label Study to Assess Consump9on of Peanut in Infants Aged 6-12 Months With Peanut Allergy Treated With Epicutaneous Peanut Immunotherapy Kirsten P. Perre+,1-3 Philippe Bégin,4,5 Douglas P. Mack,6,7 Michael O’Sullivan,8,9 Julia Upton,10,11 Audrey Dunn Galvin,12 To
Slide 2: Disclosures
Disclosures Author disclosures: • KPP has received research grants from Aravax, DBV Technologies, Novar:s, and Siolta; and consultancy fees from Aravax, Novar:s, and RAPT Therapeu:cs, paid to their ins:tu:on, outside the submiCed work • PB has received grants or contracts from ALK, DBV Technologies,
Slide 3: Epicutaneous Immunotherapy for Peanut Allergy
Epicutaneous Immunotherapy for Peanut Allergy Peanut allergy typically presents in infancy, is usually lifelong, and carries a high risk of severe, potenAally life-threatening reacAons1 VIASKIN® Peanut Patch Early iniAaAon of immunotherapy may improve treatment outcomes, as increased immune plasAcit
Slide 4: Potential for Ad-Lib Consumption of Peanut in Infants With Peanut Allergy
Poten8al for Ad-Lib Consump8on of Peanut in Infants With Peanut Allergy • Peanut allergy is associated with significant paAent and caregiver burden including risk of anaphylacAc reacAons, dietary restricAons, limitaAons on daily acAviAes, anxiety, and social isolaAon, which lead to impaired quality o
Slide 5: THRIVE Study Design: 48-Month, Phase 2, Single-Arm, Open-Label Trial
THRIVE Study Design: 48-Month, Phase 2, Single-Arm, Open-Label Trial1 Objec/ve: To assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad-lib consumpAon of peanut in infants with peanut allergy in a Phase 2 trial1,2 Screening Open-label treatment period Peanut consumpFon period Fo
Slide 6: Infants Aged 6 Through 12 Months With a Confirmed Diagnosis of Peanut Allergy Will Be Enrolled in THRIVE
Infants Aged 6 Through 12 Months With a Confirmed Diagnosis of Peanut Allergy Will Be Enrolled in THRIVE ConfirmaAon of peanut allergy diagnosis will be based on clinical history and diagnosAc assessments CLINICAL HISTORY CONFIRMATION OF PEANUT ALLERGY • No history of peanut inges#on OR • Skin prick t
Slide 7: Peanut Consumption Regimens Will Be Based on the Month 36 Food Challenge Outcome
Peanut Consump8on Regimens Will Be Based on the Month 36 Food Challenge (FC) Outcome ParAcipants will be assigned to one of three groups based on the month 36 FC outcome; consumpAon regimens during months 37-48 will be based on parAcipants’ group allocaAon Group 1 Group 2 Group 3 Par;cipant consumes
Slide 8: THRIVE Primary Endpoint Will Assess Efficacy and Safety of VIASKIN Peanut Patch in Achieving Ad-Lib Consumption
THRIVE Primary Endpoint Will Assess Efficacy and Safety of VIASKIN® Peanut Patch in Achieving Ad-Lib ConsumpDon of Peanut Primary endpoint: ParAcipants in Group 1 and Group 2 will be considered to have met ad-lib consumpAon of dietary peanut if any one of the following three criteria are met at the en
Slide 9: Summary
Summary The THRIVE trial is invesAgaAng the efficacy and safety of daily EPIT via the VIASKIN® Peanut Patch VIASKIN® Peanut Patch to achieve ad-lib consumpAon of peanuts in infants with peanut allergy • Enrollment in THRIVE is ongoing – anAcipated compleAon in 2031 Figure from DBV Technologies. Result
Slide 10: Thank you
Abstract ID: 001954 Thank you