Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT

Arcutis Biotherapeutics — Technical Presentation (March 2023)

18 slides from Arcutis Biotherapeutics's technical presentation, March 2023

  1. Slide 1: Efficacy and safety of roflumilast cream 0.15% in adults and children with atopic dermatitis

    Efficacy and safety of roflumilast cream 0.15% in adults and children aged ≥6 years with mild to moderate atopic dermatitis in two phase 3 trials (INTEGUMENT-1 and INTEGUMENT-2) Eric Simpson,1 Lawrence Eichenfield,2 Melinda Gooderham,3 Mercedes E. Gonzalez,4 Adelaide Hebert,5 Kim Papp,6 Vimal H. Pra

  2. Slide 2: Introduction

    Introduction • Topical roflumilast is being investigated as a once-daily, nonsteroidal treatment for long-term management of psoriasis (roflumilast cream 0.3% FDA-approved July 29, 2022), atopic dermatitis, and seborrheic dermatitis1 • Topical roflumilast is formulated as a water-based cream: • Exci

  3. Slide 3: Roflumilast Mechanism of Action: A Selective and Potent PDE4 Inhibitor

    Roflumilast Mechanism of Action: A Selective and Potent PDE4 Inhibitor Adenylyl cyclase T Lymphocyte • Roflumilast has a greater affinity for PDE4 than apremilast and crisaborole – 25- to >300-fold more potent in in Cell Interior vitro assays1 G-protein PDE4 coupled receptor cAMP 5’ AMP • Roflumilas

  4. Slide 4: Study Design

    Study Design Randomized, Parallel group, Double-blind, Vehicle-controlled, Multicenter Study Roflumilast Cream Endpoints 2:1 Eligibility 0.15% QD Primary • Diagnosis of mild or INTEGUMENT-1 n=433 • vIGA-AD Success* at Week 4 moderate atopic dermatitis INTEGUMENT-2 n=451 Secondary Randomize (vIGA-AD

  5. Slide 5: Reason for Discontinuation

    Reason for Discontinuation INTEGUMENT-1 INTEGUMENT-2 Roflumilast cream Vehicle cream Roflumilast cream Vehicle cream Patients, n (%) 0.15% (n=433) (n=221) 0.15% (n=451) (N=232) Completed 404 (93.3) 208 (94.1) 410 (90.9) 211 (90.9) Discontinued 29 (6.7) 13 (5.9) 41 (9.1) 21 (9.1) Reason for discontin

  6. Slide 6: Patient Demographics

    Patient Demographics INTEGUMENT-1 INTEGUMENT-2 Patients Roflumilast cream 0.15% (n=433) Vehicle cream (n=221) Roflumilast cream 0.15% (n=451) Vehicle cream (n=232) Age in years, mean (standard deviation) 28.1 (19.1) 28.5 (18.9) 27.7 (19.6) 26.2 (18.9) Sex at birth, n (%) Male 196 (45.3) 92 (41.6) 19

  7. Slide 7: Baseline Disease Characteristics

    Baseline Disease Characteristics INTEGUMENT-1 INTEGUMENT-2 Roflumilast cream Vehicle cream Roflumilast cream Vehicle cream Patients 0.15% (n=433) (n=221) 0.15% (n=451) (n=232) Baseline vIGA-AD 2 (mild) 103 (23.8) 59 (26.7) 108 (23.9) 53 (22.8) 3 (moderate) 330 (76.2) 162 (73.3) 343 (76.1) 179 (77.2)

  8. Slide 8: Percent of Patients Achieving vIGA-AD Success

    Percent of Patients Achieving vIGA-AD Success Primary Endpoint: vIGA-AD Success at Week 4 32% of patients achieved vIGA-AD Success at Week 4 29% of patients achieved vIGA-AD Success at Week 4 (INTEGUMENT-1) (INTEGUMENT-2) 100% 100% 0.15% Roflumilast (N=433) 0.15% Roflumilast (N=451) Percentage of Pa

  9. Slide 9: Percent of Patients Achieving vIGA-AD Clear or Almost Clear

    Percent of Patients Achieving vIGA-AD Clear or Almost Clear 41.5% of patients achieved vIGA-AD 0/1 at Week 4 39.0% of patients achieved vIGA-AD 0/1 at Week 4 (INTEGUMENT-1) (INTEGUMENT-2) 100% 100% Percentage of Patients (95% CI) Percentage of Patients (95% CI) 0.15% Roflumilast (N=433) 0.15% Roflum

  10. Slide 10: Percent of Patients Achieving 75% Improvement in EASI

    Percent of Patients Achieving 75% Improvement in EASI 43% of patients achieved EASI-75 at Week 4 42% of patients achieved EASI-75 at Week 4 (INTEGUMENT-1) (INTEGUMENT-2) 100% 100% 0.15% Roflumilast (N=433) 0.15% Roflumilast (N=451) Percentage of Patients (95% CI) Percentage of Patients (95% CI) Vehi

  11. Slide 11: Improvement in Pruritus: WI-NRS Success

    Improvement in Pruritus WI-NRS Success 33.6% of patients achieved WI-NRS Success at Week 4 30.2% of patients achieved WI-NRS Success at Week 4 (INTEGUMENT-1) (INTEGUMENT-2) 100% 100% 0.15% Roflumilast (N=278) 0.15% Roflumilast (N=264) Percentage of Patients (95% CI) Percentage of Patients (95% CI) V

  12. Slide 12: Daily Improvement in Pruritus

    Daily Improvement in Pruritus Daily Diary LS Mean Change from Baseline in LS Mean Change from Baseline in Daily WI-NRS Score (INTEGUMENT-1)* Daily WI-NRS Score (INTEGUMENT-2)* Day Day 0 5 10 15 20 25 0 5 10 15 20 25 0 0 Roflumilast Cream 0.15% (n=433) Roflumilast Cream 0.15% (n=451) Vehicle Cream (n

  13. Slide 13: Response in AD Patients Treated with Roflumilast Cream 0.15%

    Response in AD Patients Treated with Roflumilast Cream 0.15% Male, 10 years of age Black or African American, White Not Hispanic or Latino Baseline Week 1 Week 4 IGA=3 IGA=3 IGA=1 WI-NRS=8.0 WI-NRS=5.3 WI-NRS=1.3 PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 17-21, 2023, NEW

  14. Slide 14: Response in AD Patients Treated with Roflumilast Cream 0.15%

    Response in AD Patients Treated with Roflumilast Cream 0.15% Female, 14 years of age White Not Hispanic or Latino Baseline Week 1 Week 4 IGA=3 IGA=1 IGA=1 WI-NRS=2.0 WI-NRS=1.9 WI-NRS=1.9 PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 17-21, 2023, NEW ORLEANS, LA, USA

  15. Slide 15: Response in AD Patients Treated with Roflumilast Cream 0.15%

    Response in AD Patients Treated with Roflumilast Cream 0.15% Male, 51 years of age White Not Hispanic or Latino Baseline Week 1 Week 4 IGA=3 IGA=2 IGA=1 WI-NRS=9.0 WI-NRS=4.0 WI-NRS=2.5 PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 17-21, 2023, NEW ORLEANS, LA, USA

  16. Slide 16: Safety

    Safety INTEGUMENT-1 INTEGUMENT-2 Roflumilast cream Vehicle cream Roflumilast cream Vehicle cream Patients, n (%) 0.15% (n=433) (n=221) 0.15% (n=452) (n=230) Patients with any treatment-related TEAE 27 (6.2) 4 (1.8) 26 (5.8) 8 (3.5) Patients with any treatment-emergent SAE* 4 (0.9) 0 4 (0.9) 0 Patien

  17. Slide 17: Investigator and Patient-Rated Local Tolerability

    Investigator and Patient-Rated Local Tolerability INTEGUMENT-1 INTEGUMENT-2 7 Investigator-rated Local Tolerability 7 Investigator-rated Local Tolerability 6 6 Mean Score Mean Score 5 5 4 4 3 3 2 2 1 0.00 0.00 0.03 0.09 0.04 0.03 0.03 0.01 1 0.06 0.14 0.05 0.10 0.03 0.05 0.00 0.00 0 0 Baseline Week

  18. Slide 18: Conclusions

    Conclusions • Once-daily, non-steroidal roflumilast cream 0.15% significantly improved atopic dermatitis • Significant improvement based on EASI-75 was observed as early as 1 week after treatment initiation • Reduction in pruritus was observed at 24 hours following the first application • No AE occu

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