Dbv Technologies Sa · EURONEXT:DBV
Dbv Technologies Sa — Investor Presentation (January 2020)
73 slides from Dbv Technologies Sa's investor presentation, Jan 13, 2020
Slide 1: Unlocking the Powerful Immune Properties of the Skin
Exhibit 99.1 Unlocking the Powerful Immune Properties of the Skin to Offer Innovative Treatments to Patients January 2020Exhibit 99.1 Unlocking the Powerful Immune Properties of the Skin to Offer Innovative Treatments to Patients January 2020
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: Pioneering a New Class of Immunotherapy
Pioneering a New Class of Immunotherapy We are focused on discovering, developing and commercializing our novel skin immunotherapy product candidates using our proprietary Viaskin® Technology Platform TM • Epicutaneous immunotherapy (EPIT ) targets the immune system via intact skin with the Viaskin
Slide 4: Merging Science and Technology to Develop Novel Viaskin Technology Platform
Merging Science and Technology to Develop Novel Viaskin Technology Platform Patented electrostatic EPIT Activates the Immune System patch with Through Intact Skin condensation chamber allows the antigen to penetrate upper layer Electrospray: patented of epidermis patch manufacturing technology that
Slide 5: Significant Achievements in 2019 Provide Path to Potential U.S. Approval
Significant Achievements in 2019 Provide Path to Potential U.S. Approval of Viaskin Peanut in 2H 2020 2019 1H 2020 2H 2020 ü Viaskin Peanut BLA accepted for review by US FDA on ü PEOPLE 3-year results showed • Viaskin Peanut Target Action Oct. 4, 2019 durable, long-term clinical benefit Date of Augu
Slide 6: Peanut Allergy Places Major Burden on Patients, Families and Society
Peanut Allergy Places Major Burden on Patients, Families and Society 1 • 859,000 children ages 4-11 are diagnosed with peanut allergy in the United States 2 Significant Prevalence • Most peanut allergy patients are diagnosed by 5 years of age and 80% will not outgrow their allergy Especially in Chil
Slide 7: Avoidance Isn't Enough for Patients
Avoidance Isn’t Enough for Patients: Goal Is to Offer Additional Protection to Address This Unmet Need 1,2 Top Priority Treatment Goals for Caregivers and Physicians are the Same--They Are Seeking a Treatment That: 1. Reduces the likelihood of an allergic reaction in case of accidental exposure 2. L
Slide 8: Epicutaneous Immunotherapy Is an Innovative Approach
Epicutaneous Immunotherapy Is an Innovative Approach to Potentially Offer Long-Term Benefit Protection from Long-Term Sustained Accidental Exposure Maintenance of Effect Unresponsiveness EPIT Utilizes the Immune Tolerizing Large Dataset of 141 Children Treated OLFUS and PEOPLE Show Potential for Pro
Slide 9: Viaskin Peanut May Offer A Convenient, Easy-to-Use Treatment
Viaskin Peanut May Offer A Convenient, Easy-to-Use Treatment for Patients and Their Families • Small patch, ~1” square • Single, daily 250 µg patch applied to the back of peanut- allergic children offering constant dosing • 2-week treatment initiation leading to 24-hour wear time • Applied once dail
Slide 10: Viaskin Peanut Leads Our Food Allergy Pipeline
Viaskin Peanut Leads Our Food Allergy Pipeline with a Long-Term, Focused Clinical Program 1575 patient-years to date in Phase III program Consistent treatment benefit observed in multiple trials Year 1 Year 2 Year 3 Year 4 Year 5 VIPES OLFUS-VIPES DBPC Open Label Extension 6-55 y.o N=221 6-55 y.o. N
Slide 11: PEPITES Pivotal Phase III Trial Results
PEPITES Pivotal Phase III Trial Results (Fleischer, JAMA 2019) Placebo Pivotal Global Randomized DBPC Phase 3 Trial Screening • 356 children aged 4 to 11 years 250 µg • 31 study locations (United States, Canada, Australia, Germany, and Ireland) M12 M0 NCT02636699 DBPCFC Randomization* † Primary Endp
Slide 12: Data from Phase II and III Studies Showed Statistically Significant Treatment Effect
Data from Phase II and III Studies Showed Statistically Significant Treatment Effect • After 12 months, a significantly larger percentage 1 of participants responded to Viaskin Peanut Response Rate (ITT) treatment vs placebo patch 35.3% vs 13.6% 40 1 P<0.001 (P<0.001) 35 − The prespecified 15% lower
Slide 13: Quantitative Risk Assessment Modeling Suggests Reduced Risk
Quantitative Risk Assessment Modeling Suggests Reduced Risk of Accidental Ingestion Reactions Change in ED in Children 4 to 11 years of 1,3† age after 12 months 100% ED Increase • In a post-hoc analysis, 53.1% of >4x more likely in subjects on Viaskin Peanut 250 µg ED Stable Viaskin Peanut 28.0% 250
Slide 14: Treatment Adherence Is High While Discontinuation Due to AEs is Low
Treatment Adherence Is High While Discontinuation Due to AEs is Low • 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) EPIT has a very • Treatment adherence* was high (98.5%) across
Slide 15: PEOPLE: Largest Long-Term Peanut Allergy Immunotherapy Trial to Date
PEOPLE: Largest Long-Term Peanut Allergy Immunotherapy Trial to Date M36 M38 M48 M60 PEPITES PEOPLE M24 N=356 213 198 184 148 250 µg (n=238) SU 4-11 years Placebo (n=118) SU 107 100 91 83 Roll-over M0 to 250 μg M12 M12 M24 M36 M38 M48 M60 93% of patients that completed PEPITES enrolled in PEOPLE Dou
Slide 16: Clinically Meaningful Changes in Eliciting Dose Maintained or Improved Over 3 Years
Clinically Meaningful Changes in Eliciting Dose Maintained or Improved Over 3 Years PEOPLE PP (N=141) % of Patients M0 M12 M36 • 75.9% (107/141) demonstrated an increase in ED from baseline (M0) to Month 36 4 18 >2000* 14 6 2000 • 51.8% (73/141) reached an ED of ≥1,000 mg at 22 27 1000 Month 36 35 3
Slide 17: Marked Improvements in Cumulative Reactive Dose with Long-Term EPIT
Marked Improvements in Cumulative Reactive Dose (CRD) with Long-Term EPIT Treatment 3,000 • In PEOPLE, 13.5% (19/141) of patients tolerated* - median value the full DBPCFC at 36 months (cumulative dose of 2,500 5,444 mg) 2,000 • Mean CRD of 1,768.8 mg, equivalent to roughly 1768.8 6 peanuts, at Mont
Slide 18: Consistent Treatment Effect Across Studies Using Different Endpoint Criteria
Consistent Treatment Effect Across Studies Using Different Endpoint Criteria PEOPLE results when analyzed per: PEOPLE PEPITES OLFUS • Phase III PEOPLE key efficacy measurement: 51.8% reached an ED of Criterion Criterion Criterion 100% ≥1000 mg at Month 36 PEOPLE Per Protocol (PP) − Phase III PEPITES
Slide 19: Continued Immune Modulation Beyond 12 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 progressiv
Slide 20: Safety Profile Consistent with 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 pat
Slide 21: Preparation Underway for Potential Viaskin Peanut Launch in the U.S.
Preparation Underway for Potential Viaskin Peanut Launch in the U.S. in 2H 2020 Patients and Families Market Access Healthcare Professionals Allergists • Education and marketing initiatives • Predominately commercial market 2 • Approximately 4,500 allergists in the U.S. focused on caregivers of pean
Slide 22: Looking Ahead to Viaskin Peanut for Toddlers: Phase III Trial in Ages 1-3
Looking Ahead to Viaskin Peanut for Toddlers: Ongoing Phase III Trial in Children Ages 1-3 Positive DSMB from Part A: No safety concerns identified Part B: ~350 additional patients Highest safe dose (250 µg) Part A: 51 patients randomized n = ~233 Placebo (n = ~10) EPOPEX 100 µg (n = ~20) Open Label
Slide 23: Applying This Platform to Other Food Allergies
Applying This Novel, Innovative Platform to Other Food Allergies Where Unmet Needs Exist Following Potential Commercialization of Viaskin Peanut, If Approved, Comprehensive Pipeline Review Planned DEVELOPMENT STAGE PROGRAM INDICATION DISCOVERY PRE-CLINICAL PHASE I PHASE II PHASE III FDA Review Ages
Slide 24: DBV Is Positioned to Deliver the First Epicutaneous Immunotherapy
DBV Is Positioned to Deliver the First Epicutaneous Immunotherapy to Peanut-Allergic Children in 2H 2020 2H 2020 1H 2020 Potential FDA approval of PEOPLE 3-year topline results Viaskin Peanut EPITOPE Part A results and Potential US launch of Viaskin Peanut, if approved enrollment update for Part B A
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Slide 26: Appendix
APPENDIXAPPENDIX
Slide 27: Viaskin Platform
Viaskin PlatformViaskin Platform
Slide 28: EPIT: Unlocking the Immune Properties of the Skin with the Viaskin Patch
EPIT: Unlocking the Immune Properties of the Skin with the Viaskin Patch EPIT targets the immune system on intact skin • Condensation chamber formed by Viaskin patch allows natural epidermal water loss to solubilize dry antigens • Langerhans cells capture solubilized antigen in the epidermis • Kerat
Slide 29: The Skin Has Important Immune Properties
The Skin Has Important Immune Properties • Immune functions of the skin include – Responding to trauma, toxins, and infectious agents – Maintaining self-tolerance, preventing allergy, Keratinocyte and inhibiting autoimmunity Epidermis • Keratinocytes Langerhans cell – Distinguish pathogens from harm
Slide 30: Core Innovation: Differentiated Electrospray Technology
Core Innovation: Differentiated Electrospray Technology Regulated flow of dissolved antigen • Dose flexibility – Biological API deposit between 20 and 500 µg/cm2 • API stability Capillary – Solid & soluble protein layer, no glue nozzle High voltage • Homogeneous repartition of API (up to 20,000 V) –
Slide 31: Robust IP Portfolio
Robust IP Portfolio: Core Technology, MoA & Specific Indications ALLERGY 0110 – EPIT Peanut 0109 – EPIT Method MANUFACTURING 0111 - Eczema treatment Broad geographic applications • USA, Europe, Australia, 0117 - Encapsulated food allergen 0121 – ElectroFlow Canada 0112 – Eosinophilic esophagitis 010
Slide 32: Operational Readiness: Fully-Integrated End-to-End Process
Operational Readiness: Fully-Integrated End-to-End Process In-Place Active Pharmaceutical Ingredient Primary Packaging (API) Raw Source Bulk Final Material Material formulation Product (SM) API process at Sanofi Source Material process Final Product process at Fareva API dry powder: highly purified
Slide 33: Established Proprietary & Patented Manufacturing Capabilities
Established Proprietary & Patented Manufacturing Capabilities Developed by DBV • Sufficient supply for anticipated launch of Viaskin Peanut in 2H 2020, if approved • Modular components à technology versatility – Highly scalable – Broadly applicable platform • Manufacturing capabilities – In-house de
Slide 34: Viaskin Peanut Phase III Program: PEPITES & REALISE
Viaskin Peanut Phase III Program: PEPITES & REALISEViaskin Peanut Phase III Program: PEPITES & REALISE
Slide 35: Measuring Efficacy: Double-Blind Placebo-Controlled Food Challenge
Measuring Efficacy: Double-Blind Placebo-Controlled Food Challenge Baseline 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg Month 12* 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg 1,000 mg 2,000 mg DBPCFC: Efficacy Outcome Scoring with Standardized Challenge Matrix • Standardized GMP challenge CATEGORIES OBJECTIVE SYMPTO
Slide 36: PEPITES Pivotal Phase III Trial Results
PEPITES Pivotal Phase III Trial Results (Fleischer, JAMA 2019) Placebo Pivotal Global Randomized DBPC Phase 3 Trial Screening • 356 children aged 4 to 11 years 250 µg • 31 study locations (United States, Canada, Australia, Germany, and Ireland) M12 M0 NCT02636699 DBPCFC Randomization* Primary Endpoi
Slide 37: Trial Population Included Patients with Multiple Allergic Conditions
Trial Population Included Patients with Multiple Allergic Conditions (Fleischer, JAMA 2019) • Patient population included a high percentage of subjects with additional allergic conditions 356 Patients Randomized, n (%) Medical History of Patients* 100% • Active (VP250 μg): 238 (67%) 85.7% • Placebo:
Slide 38: Primary Efficacy Outcome Showed Statistically Significant Treatment Effect
Primary Efficacy Outcome Showed Statistically Significant Treatment Effect (Fleischer, JAMA 2019) Response Rate (ITT) • After 12 months, a significantly larger 40 percentage of participants responded to P<0.001 Viaskin Peanut treatment vs placebo patch 35 35.3% vs 13.6% (P<0.001) 35.3% 30 Δ= 21.7% 2
Slide 39: Cumulative Reactive Dose Increased Over 12 Months of Treatment
Cumulative Reactive Dose (CRD) Increased Over 12 Months of Treatment (Fleischer, JAMA 2019) CRD After 12 Months • A difference in CRD was observed 1200 P<0.001* between the active and placebo Median groups (P<0.001*) 1000 905.7 800 • The median CRD in participants in the 600 Viaskin® Peanut 250 µg g
Slide 40: Increased ED in Majority of Participants Treated with Viaskin Peanut
Increased ED in Majority of Participants Treated with Viaskin Peanut (Fleischer, JAMA 2019) 1,3† Change in ED in Children 4 to 11 years of age • In a post-hoc analysis, 53.1% of 100% ED Increase subjects on Viaskin Peanut 250 µg >4x more likely in Viaskin Peanut ED Stable increased their baseline ED
Slide 41: Changes in Biomarkers Support Immunomodulatory Effect
Changes in Biomarkers Support Immunomodulatory Effect of Viaskin Peanut (Fleischer, JAMA 2019) • 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 Vias
Slide 42: High Adherence and Low Discontinuation Due to TEAEs
High Adherence and Low Discontinuation Due to TEAEs (Fleischer, JAMA 2019) • 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 tota
Slide 43: Low Rates of Treatment-Related Serious AEs
Low Rates of Treatment-Related Serious AEs (Fleischer, JAMA 2019) • Viaskin Peanut 250 µg: 12 SAEs* in 10 Serious AEs* participants (4.2%); Placebo: 6 SAEs in 6 10% Placebo, n=118 participants (5.1%) Viaskin Peanut 250 µg, n=238 8% – 4 SAEs in 3 Viaskin Peanut participants considered related to trea
Slide 44: PEPITES Post-Hoc Analysis Using VIPES Responder Definition
PEPITES Post-Hoc Analysis Using VIPES Responder Definition Suggests Consistent Treatment Effect Observed from Phase II to Phase III Actual Reported Response PEPITES Response Rate Using Rate in PEPITES (%) the VIPES Response Criteria 50 50 45.8% LCL 12.4 LCL 18.9 UCL 29.8 UCL 37.4 40 40 35.3% Δ = 28.
Slide 45: Positive Phase III REALISE Results Support Regulatory Filings
Positive Phase III REALISE Results Support Regulatory Filings for Viaskin Peanut Positive 6-month safety results confirmed the safety and tolerability profile observed in PEPITES, VIPES and CoFAR6 Placebo 250 µg 393 peanut allergic children 32 centers in North America 250 µg Safety Safety Safety Saf
Slide 46: Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6
Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6Viaskin Peanut Phase II Program: VIPES, OLFUS-VIPES & COFAR6
Slide 47: VIPES: Dose-Finding Phase IIb Efficacy and Safety Trial
VIPES: Dose-Finding Phase IIb Efficacy and Safety Trial (Sampson, JAMA 2017) Placebo 50 µg 221 stratified patients, 22 250 µg centers in US, Canada, France, 100 µg Poland, and Netherlands 250 µg M0 M12 M0 M12 M24 M26 OLFUS-VIPES VIPES Open Label Follow-Up Study Dose-finding Clinical Trial Patient Po
Slide 48: VIPES: Patient Population Snapshot at Baseline
VIPES: Patient Population Snapshot at Baseline 221 patients randomized 40 39 38 • 113 Children (6-11) • 73 Adolescents (12-17) & 35 Adults (18+) Highly allergic patients (median) 23 • Children = 30 mg 18 • Adolescents & Adults = 100 mg 17 13 13 Very high IgE levels: > 100 kU/L 11 • 47% of Children 6
Slide 49: VIPES: Phase IIb Results Key Conclusions
VIPES: Phase IIb Results Key Conclusions • Primary endpoint met with Viaskin Peanut 250 µg – Greatest response in children ages 6-11 (53.6% vs. 19.4%, p = 0.008) • Increase in threshold reactivity of peanut protein showed a clear dose response with greatest benefit in the 250 µg arm – In the childre
Slide 50: VIPES: Primary Endpoint Met; Focus On Children
VIPES: Primary Endpoint Met; Focus On Children (Ages 6-11) Response rate in children across doses after 12 months p = 0.008 80% 70% 60% 50% 40% 30% 57.1% 53.6% 46.2% 20% 10% 19.4% 0% Placebo 50 µg 100 µg 250 µg n = 31 n = 28 n = 26 n = 28 50 Epicutaneous immunotherapy and Viaskin™ Peanut are under c
Slide 51: VIPES: Peanut Consumption In Children
VIPES: Peanut Consumption In Children (Ages 6-11) Clear Dose Response, Clear Magnitude Of Effect Increase in CRD in children after 12 months (Mean and Median)* p < 0.001 2,000 mg 4-5 peanuts 1,500 mg 1,121.0 mg 1,000 mg 570.0 mg 471.2 mg Median = 400.0 500 mg Median = 114.5 60.8 mg Median = 135.0 Me
Slide 52: VIPES: Immunological Changes In Children Supports Treatment Effect
VIPES: Immunological Changes In Children (Ages 6- 11) Supports Treatment Effect Peanut-specific IgE (kU/L) Peanut-specific IgG4 (mg/L) 52 Epicutaneous immunotherapy and Viaskin™ Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.VIP
Slide 53: VIPES: Primary Efficacy Endpoint Met
VIPES: Primary Efficacy Endpoint Met Identified Viaskin 250 µg As Phase III Dose Response rate across doses after 12 months p = 0.01 70% 60% 50% 40% 30% 50.0% 45.3% 20% 41.1% 10% 25.0% 0% Placebo 50 µg 100 µg 250 µg n = 56 n = 53 n = 56 n = 56 53 Epicutaneous immunotherapy and Viaskin™ Peanut are un
Slide 54: VIPES: Adolescents & Adults High Placebo Response Rate
VIPES: Adolescents & Adults High Placebo Response Rate Distorts Analysis Patients aged 12-55 response rate across doses p = 0.40 70% 60% 50% 40% 30% 46.4% 20% 36.7% 10% 32.0% 32.0% 0% Placebo 50 µg 100 µg 250 µg n = 25 n = 25 n = 30 n = 28 54 Epicutaneous immunotherapy and Viaskin™ Peanut are under
Slide 55: VIPES: Adolescents & Adults Changes From Baseline CRD
VIPES: Adolescents & Adults Changes From Baseline CRD Indicate Dose Response Trend Patients aged 12-55 increase in baseline CRD at 12 months across doses 1,500.0 mg 1,000.0 mg 842.3 mg 837.4 mg 619.2 mg 528.4 mg 500.0 mg Median = 335.0 Median = 30.0 Median = 0.0 Median = 10.0 0.0 mg Placebo 50 μg 10
Slide 56: VIPES: Adolescents & Adults Immunological Changes
VIPES: Adolescents & Adults Immunological Changes Support Dose Response Trend Peanut-specific IgE (kU/L) Peanut-specific IgG4 (mg/L) 56 Epicutaneous immunotherapy and Viaskin™ Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.VIPES
Slide 57: VIPES: Post Hoc Analysis Using PEPITES Responder Definition
VIPES: Post Hoc Analysis Using PEPITES Responder Definition VIPES Children (6-11 years) - Viaskin 250 μg at M12 Reported Response Rate VIPES Response Rate Using the PEPITES Response Criteria 80% 80% p = 0.0007 p = 0.008 70% 70% 60% 60% 50% 50% 40% 40% 30% 30% 53.6% 46.4% 20% 20% 10% 10% 6.5% 19.4% 0
Slide 58: OLFUS-VIPES: Open-label Follow-up Trial To VIPES
OLFUS-VIPES: Open-label Follow-up Trial To VIPES Extension Trial To Support Use Of Viaskin Peanut Placebo 221 stratified patients, 22 50 µg 250 µg centers in US, Canada, 100 µg France, Poland, and Netherlands 250 µg M0 M12 M0 M12 M24 M26 OLFUS-VIPES VIPES Open Label Follow-Up Study Dose-finding 171
Slide 59: OLFUS-VIPES: Long-term Extension Data Shows Benefit Increases Over Time
OLFUS-VIPES: Long-term Extension Data Shows Benefit Increases Over Time in Phase IIb Study Response Rate at OLFUS: Cumulative Reactive Dose in OLFUS Baseline, Year-1 and Year-2 Mean ± 95% CI Observed values, ITT 100% 5,000 mg 2,453.9 mg 3,000 mg 80% 1,883.5 mg 2,000 mg 60% Median = Median = 1,067.8
Slide 60: OLFUS-VIPES: Immunological Changes, Ages 6-11
OLFUS-VIPES: Immunological Changes, Ages 6-11 Relative Change IgE Relative Change IgG4 Median ± IQ Median ± IQ 4,000 100 3,000 2,000 50 1,000 0 500 -50 0 3 6 12 18 24 30 36 Months 0 3 6 12 18 24 30 36 Months Epicutaneous immunotherapy and Viaskin™ Peanut are under clinical investigation and have not
Slide 61: OLFUS-VIPES: Long-term Follow-up Data Key Conclusions
OLFUS-VIPES: Long-term Follow-up Data Key Conclusions Late Breaking Oral Presentation at AAAAI 2017 • In children treated for three years with a 250 µg dose there was a trend of progressive response to treatment as measured by increased response rate, higher CRD* and serological changes – Treatment
Slide 62: CoFAR6: Efficacy And Safety – NIAID Sponsored Phase II
CoFAR6: Efficacy And Safety – NIAID Sponsored Phase II 250 mg Viaskin Peanut Enrollment 221 stratified patients, 22 100 mg Viaskin Peanut n = 75 250 mg Viaskin Peanut centers in US, Canada, France, Poland, and Entry OFC positive Netherlands Placebo to cumulative dose of < 1044 mg Week 130 peanut pro
Slide 63: CoFAR6: Primary Endpoint Was Met
CoFAR6: Primary Endpoint Was Met All Patients 4 – 11 Years Primary Endpoint Pre-specified Analysis • No SAEs or Epinephrine p = <0.001 p = 0.003 due to drug p = <0.001 p = 0.005 100 100 • 96% compliance 61.1% 58.8% • Primary endpoint met (p 48.0% = 0.003) 50 50 45.8% • Significant age by treatment i
Slide 64: Viaskin Milk Phase II Program: MILES
Viaskin Milk Phase II Program: MILESViaskin Milk Phase II Program: MILES
Slide 65: Viaskin Milk: Milk Allergy Phase II Study Identified Safe/Effective Dose
Viaskin Milk: Milk Allergy (CMPA) Phase II Study Identified Safe/Effective Dose for Children Open Label Phase I (Part A) Phase II (Part B) Cohort at 500µg dose Placebo DSMB FDA & 150 µg 300 µg*** Pediatric Phase I/II DSMB 300 µg USA & Canada Cohort at 300µg dose Part A: 18 patients 500 µg DSMB Part
Slide 66: MILES Patient Population at Baseline
MILES Patient Population at Baseline Medical history of patients 198 patients randomized n% • 152 Children (2-11) Asthma 139 70.2 • 46 Adolescents (12-17) Atopic Dermatitis 139 70.2 CRD of Cow’s Milk Allergic Rhinitis 144 72.7 Polyallergic 178 89.9 Mean • Children: 216.3 mg Mean Cow’s Milk sIgE • Ad
Slide 67: MILES Results: Support Viaskin Milk 300µg
MILES Results: Support Viaskin Milk 300µg as the Potential First Treatment for CMPA in Children 2-11 Response Rate (ITT*) Favorable safety, tolerability and compliance p = 0.733 • Overall discontinuation rate of 4.5% p = 0.042 p > 0.999 – 1.5% dropout due to AEs • Most AEs related to application sit
Slide 68: MILES Results: Significant Improvement in Threshold Reactivity
MILES Results: Significant Improvement in Threshold Reactivity with Viaskin Milk 300µg in Children 2-11 Change of CRD (PP*) Change of CRD (ITT*†) p = 0.822 p = 0.985 1800 1800 p = 0.043 p = 0.045 1600 1600 p = 0.809 p = 0.617 1340.3 1400 1400 1322.4 1200 1200 1000 1000 1000 848.0 1000 839.8 800 800
Slide 69: MILES Results: All Dose Cohorts At Month-12 Response Rate
MILES Results: All Dose Cohorts At Month-12 Response Rate, Overall Population (ITT*) Response Rate (ITT*) Response Rate (PP) p = 0.522 p = 0.682 p = 0.027 70 70 p = 0.649 p = 0.085 p = 0.641 60 60 50 50 40 40 30 30 55.0% 49.0% 20 20 36.7% 37.2% 36.2% 36.1% 30.2% 28.9% 10 10 0 0 Placebo VM150 µg VM30
Slide 70: MILES Results: All Dose Cohorts At Month-12 CRD
MILES Results: All Dose Cohorts At Month-12 CRD, Overall Population (ITT) Mean Increase in CRD p = 0.736 p = 0.008 p = 0.189 1,201.0 745.1 723.5 555.5 Median Median 400 mg 300 mg Median Median 100 mg 93 mg Placebo 150 µg 300 µg 500 µg n = 39 n = 37 n = 36 n = 34 Epicutaneous immunotherapy and Viaski
Slide 71: MILES Immunologic Data: sIgG4
MILES Immunologic Data in Children 2-11 (ITT): Significant Immunomodulation with Viaskin Milk sIgG4 casein, mg/L sIgG4 α-lactalbumin, mg/L sIgG4 β-lactoglobulin, mg/L p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 p ˂ 0.001 • For sIgE levels in children, there is a t
Slide 72: MILES Immunologic Data: sIgE
MILES Immunologic Data in Children 2-11 (ITT): Significant Immunomodulation with Viaskin Milk sIgE casein, kUA/L sIgE α-lactalbumin, kUA/L sIgE β-lactoglobulin, kUA/L p = 0.018 p = 0.003 p = 0.008 p = 0.166 p = 0.336 p = 0.201 p = 0.307 p = 0.090 p = 0.172 • There is a trend towards reduction of sIg
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DBV Technologies — Investor Presentation (January 2020) on 6ix