Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Technical Presentation (January 2020)
11 slides from Dbv Technologies Sa's technical presentation, Jan 9, 2020
Slide 1: Viaskin Peanut in children with peanut allergy: PEOPLE trial topline results
Investigational Viaskin peanut in children with peanut allergy the Pepites open label extension (PEOPLE) trial: TOPLINE RESULTS Epicutaneous immunotherapy and Viaskin® Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. Exhibit 99.2
Slide 2: Safe harbor
Safe harbor This presentation contains forward looking statements including, but not limited to, statements concerning the outcome or success of DBV’s clinical trials; its ability to successfully gain regulatory approvals and commercialize products; its ability to successfully advance its pipeline o
Slide 3: Peanut allergy represents a serious burden amid constant fear of accidental exposure
Peanut allergy REPRESENTS a serious BURDEN AMID CONSTANT FEAR OF ACCIDENTAL EXPOSURE Peanut allergy is one of the most common, persistent and potentially life-threatening food allergies, affecting nearly one million children in the U.S.1 The majority of peanut-allergic children will react to 300 mg
Slide 4: PEOPLE: an open-label extension of PEPITES assessing long-term effects of Viaskin Peanut
PEOPLE: an open-label extension of PEPItes assessing long-term effects of viaskin peanut Patients who completed the Phase III PEPITES trial were eligible to enroll in PEOPLE Safety and efficacy of long-term treatment with VP 250 μg, up to 5 years of treatment Assessment of clinical benefit after 36
Slide 5: Largest long-term peanut allergy immunotherapy trial to date
M12 Placebo (n=118) 250 µg (n=238) N=356 4-11 years 213 107 M0 largest long-term peanut allergy immunotherapy trial to date Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. ED=eliciting dose
Slide 6: Clinically meaningful changes in eliciting dose maintained or improved over 3 years
Clinically meaningful changes in Eliciting Dose maintained or improved over 3 years 75.9% (107/141) demonstrated an increase in ED from baseline (M0) to Month 36 51.8% (73/141) reached an ED of ≥1,000 mg at Month 36 40.4% (57/141) reached an ED of ≥1,000 mg at Month 12† 67.4% (62/92) of patients who
Slide 7: Marked improvements in cumulative reactive dose with long-term EPIT treatment
Marked improvements in cumulative reactive dose (CRD) with long-term EPIT treatment - median value In PEOPLE, 13.5% (19/141) of patients tolerated* the full DBPCFC at 36 months (cumulative dose of 5,444 mg) Mean CRD of 1,768.8 mg, equivalent to roughly 6 peanuts, at Month 36 24.1% (34/141) reached a
Slide 8: Consistent treatment effect across studies using different endpoint criteria
Consistent treatment effect across studies USING DIFFERENT endpoint criteria *Results for 250 µg cohort, ages 6-11; †SU defined in PEOPLE as maintaining ED ≥1,000 mg; all participants who reached an ED ≥1,000 mg at Month 36 were eligible to continue the study for 2 additional months without treatmen
Slide 9: Continued immune modulation beyond 18 months
Continued Immune modulation beyond 12 months Exploratory analyses across both PEPITES and PEOPLE showed that changes in peanut-specific biomarkers, including immunoglobulin G4 (IgG4) and immunoglobulin E (IgE), support the immunomodulatory effect with Viaskin Peanut Peanut IgG4 levels progressively
Slide 10: Safety profile consistent with that observed in the clinical program to date
safety profile consistent with that observed in the clinical program to date No treatment-related serious adverse events (SAEs) were reported Most commonly reported treatment-related AEs were mild to moderate skin reactions Local administration site reactions observed in 92.9% (184/198) of patients
Slide 11: Summary
Summary Approximately 3 out of 4 patients experienced an increase in their ED from baseline, showing a majority of patients benefited from the investigational therapy 51.8% reached an eliciting dose (ED) of at least 1,000 mg peanut protein (about three peanuts) Robust treatment response with 13.5% o
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