Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT

Arcutis Biotherapeutics — Technical Presentation (October 2020)

12 slides from Arcutis Biotherapeutics's technical presentation, October 2020

  1. Slide 1: The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis

    The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Atopic Dermatitis: Phase 2 Proof-of-Concept Study Melinda J. Gooderham,1 Leon H. Kircik,2 Matthew Zirwas,3 Mark Lee,4 Steven E. Kempers,5 Zoe D. Draelos,6 Laura Ferris,7 Terry M. Jones, Etienne Saint-Cyr Proulx,9 Robert Bissonnette,9 Ne

  2. Slide 2: Disclosures

    Disclosures M.J. Gooderham has been a speaker, advisory board member, investigator and/or consultant for AbbVie, Akros, Amgen, Arcutis, BMS, Boehringer Ingelheim, Celgene, Dermavant, Dermira, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Rege

  3. Slide 3: Background

    Background • Majority of patients with atopic dermatitis are treated with topical anti-inflammatory therapy: corticosteroids or calcineurin inhibitors, in combination with emollients1 – Side effects and poor adherence limit long-term use of topical corticosteroids – Topical calcineurin inhibitors ma

  4. Slide 4: Study Design

    The Safety and Efficacy of Roflumilast Cream in Atopic Dermatitis: Study Design Randomized, double-blind, vehicle-controlled, multicenter study 1:1:1 Roflumilast cream ENDPOINTS* 0.15% QD • Primary: EASI change from baseline ELIGIBILITY • Secondary: • Mild or moderate Randomization – EASI % change f

  5. Slide 5: Baseline Characteristics

    Baseline Characteristics Roflumilast 0.15% Roflumilast 0.05% Vehicle (n=45) (n=46) (n=45) Age, mean years (SD) 38.0 (16.5) 44.3 (17.0) 42.4 (17.6) Sex, female, n (%) 33 (73.3) 31 (67.4) 29 (64.4) Race, n (%) White 24 (53.3) 32 (69.6) 32 (71.1) Black 14 (31.1) 11 (23.9) 11 (24.4) Multiple/other 7 (15

  6. Slide 6: Severity of Atopic Dermatitis Improved With Roflumilast Cream

    Severity of Atopic Dermatitis Improved With Roflumilast Cream Absolute EASI Change From Baseline (Primary Endpoint) Week 4 0 • At this early timepoint of LS Mean Change From Baseline -1 4 weeks, there was -2 -4.8 improvement in atopic -3 dermatitis severity, yet (95% CI) -4 -6.0 not statistically si

  7. Slide 7: Secondary and Exploratory Endpoints Showed Significant Improvement Over Vehicle

    Secondary and Exploratory Endpoints Showed Significant Improvement With Roflumilast Cream Over Vehicle EASI Percent vIGA-AD Score of Clear Change From Baseline EASI-75 Responder Rate or Almost Clear 0 100 100 P=0.045 LS Mean Change From Baseline, -10 90 90 P=0.009 P=0.040 -20 80 80 Patients, % (95%

  8. Slide 8: Efficacy of Roflumilast Cream Continued to Improve Through Week 4

    Efficacy of Roflumilast Cream Continued to Improve Through Week 4 EASI Percent vIGA-AD Score of Clear or Change From Baseline Almost Clear Week 1 Week 2 Week 4 60 P=0.040 0 LS Mean Change From Baseline, -10 50 -20 -30 40 P=0.035 Patients, % % (95% CI) -40 30 -50 -60 20 -70 10 -80 -90 0 P=0.049 Week

  9. Slide 9: Roflumilast Cream Improved Severity of Atopic Dermatitis

    Roflumilast Cream Improved Severity of Atopic Dermatitis Roflumilast 0.15% Vehicle vIGA-AD = 3 vIGA-AD = 3 Baseline vIGA-AD = 2 vIGA-AD = 3 EASI CFB = -77% EASI CFB = -27% Week 4 9 CFB: change from baseline; EASI: Eczema Area and Severity Index; vIGA-AD: Validated Investigator Global Assessment for

  10. Slide 10: TEAEs Uncommon; Similar Incidence Across Groups

    TEAEs Uncommon; Similar Incidence Across Groups • Safety and tolerability Category, n (%) Roflumilast 0.15% (n=45) Roflumilast 0.05% (n=46) Vehicle (n=45) of roflumilast was Patients with similar to vehicle group Any TEAE 12 (26.7) 10 (21.7) 6 (13.3) • All TEAEs were mild or Any treatment-related TE

  11. Slide 11: Conclusions

    Conclusions • In this small proof-of-concept study, once-daily roflumilast cream demonstrated efficacy compared with vehicle cream in atopic dermatitis – Primary endpoint showed a trend towards, but did not reach, statistical significance – Statistical significance was reached for other efficacy end

  12. Slide 12: Acknowledgements

    Acknowledgements • Thank you to the investigators and their staff for their participation in the trial – Canada • Melinda Gooderham, Mani Raman, Etienne Saint-Cyr Proulx – United States • Neal Bhatia, Robert Call, Kenneth Dawes, Marta Delgado, Zoe Draelos, Laura Ferris, Christina Feser, Rion Forconi

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