Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT

Arcutis Biotherapeutics — European Academy of Dermatology and Venereology Spring Symposium 2021

14 slides from Arcutis Biotherapeutics's conference presentation, May 6, 2021

  1. Slide 1: Roflumilast Cream in Chronic Plaque Psoriasis: DERMIS-1 and DERMIS-2 Phase 3 Trials

    Roflumilast Cream, a Once-Daily, Potent Phosphodiesterase-4 Inhibitor, in Chronic Plaque Psoriasis Patients: Efficacy and Safety From DERMIS-1 and DERMIS-2 Phase 3 Trials Mark Lebwohl,1 Leon H. Kircik,2 Angela Moore,3 Linda Stein Gold,4 Zoe D. Draelos,5 Melinda J. Gooderham,6 Kim A. Papp,7 Jerry Bag

  2. Slide 2: Introduction

    Introduction • No novel nonsteroidal topical therapies for plaque psoriasis have been approved in more than 2 decades, and available topical treatments are less than ideal, necessitating a trade-off between efficacy and tolerability1 • Roflumilast is a highly potent phosphodiesterase-4 inhibitor bei

  3. Slide 3: DERMIS-1 & DERMIS-2: Identical Study Design and Endpoints

    DERMIS-1 & DERMIS-2: Identical Study Design and Endpoints Randomized, Double-blind, Vehicle-controlled, Multicenter Studies (Two identical, parallel phase 3 studies) 2:1 Endpoints Roflumilast cream Primary 0.3% QD • IGA Success at Week 8 Eligibility Randomize • Diagnosis of at least mild Secondary p

  4. Slide 4: Patient Disposition: Few Patients Discontinued Due to Adverse Events

    Patient Disposition: Few Patients Discontinued Due to Adverse Events DERMIS-1 DERMIS-2 Roflumilast cream Roflumilast cream 0.3% Vehicle 0.3% Vehicle Patients, n (%) (n=286) (n=153) (n=290) (n=152) Completed 255 (89.2) 133 (86.9) 264 (91.0) 131 (86.2) Prematurely discontinued 31 (10.8) 20 (13.1) 26 (

  5. Slide 5: Baseline Demographics (ITT Population)

    Baseline Demographics (ITT Population) DERMIS-1 DERMIS-2 Roflumilast cream Roflumilast cream 0.3% Vehicle 0.3% Vehicle (n=286) (n=153) (n=290) (n=152) Age in years, mean (SD) 47.6 (14.09) 48.7 (15.77) 46.9 (15.07) 47.1 (14.07) Gender Male, n (%) 189 (66.1) 96 (62.7) 176 (60.7) 100 (65.8) Female, n (

  6. Slide 6: Baseline Disease Characteristics (ITT Population)

    Baseline Disease Characteristics (ITT Population) DERMIS-1 DERMIS-2 Roflumilast cream Roflumilast cream 0.3% Vehicle 0.3% Vehicle (n=286) (n=153) (n=290) (n=152) Psoriasis-affected BSA, mean % (SD) 6.3 (4.38) 7.4 (4.76) 7.1 (4.84) 7.7 (5.05) PASI, mean score (SD) 6.3 (3.15) 6.8 (3.70) 6.5 (3.22) 7.0

  7. Slide 7: Robust Efficacy on IGA Success in Both Phase 3 Studies

    Robust Efficacy on IGA Success in Both Phase 3 Studies IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline IGA Success IGA Success DERMIS-1 DERMIS-2 100% 100% 90% 90% 80% 80% 70% 70% % of Patients % of Patients 60% 60% 50% *** 50% 42.4% *** *** 40% 37.5% 40% 33.3% *

  8. Slide 8: Roflumilast Was Highly Effective for Intertriginous Plaques

    Roflumilast Was Highly Effective for Intertriginous Plaques in DERMIS-1 and DERMIS-2 I-IGA Success = Clear or Almost Clear with at least a 2-grade improvement from baseline I-IGA Success and I-IGA Clear I-IGA Success and I-IGA Clear DERMIS-1 DERMIS-2 100 100 90 90 80 *** 80 ** 71.2 68.1 70 63.5 70 *

  9. Slide 9: Roflumilast Statistically Superior to Vehicle for PASI-75 at All Timepoints

    Roflumilast Was Statistically Superior to Vehicle for Improvement of Psoriasis (PASI-75) at All Timepoints Proportion of Patients Achieving PASI-75 Proportion of Patients Achieving PASI-75 DERMIS-1 DERMIS-2 100 100 90 90 80 80 70 70 % of Patients % of Patients 60 60 *** 50 41.6 50 *** *** 39.0 40 40

  10. Slide 10: Rapid Itch Response in Both DERMIS-1 and DERMIS-2

    Rapid Itch Response in Both DERMIS-1 and DERMIS-2 Proportion of patients who achieved a ≥4-point improvement in WI-NRS from baseline score of ≥4 100 DERMIS-1 100 DERMIS-2 90 90 80 *** 80 *** 67.5 *** 69.4 70 *** 70 *** 62 *** 57.8 56.6 % of Patients % of Patients 60 60 50.2 50 50 ** 41.9 40 34.9 40

  11. Slide 11: Patient Examples Illustrating Efficacy of Roflumilast Cream 0.3%

    Patient Examples Illustrating Efficacy of Roflumilast Cream 0.3% From DERMIS-1 & DERMIS-2 Baseline Week 2 Week 4 Week 6 Week 8 Knee IGA = 3 IGA = 2 IGA = 2 IGA = 1 IGA = 1 Axillae I-IGA = 3 I-IGA = 3 I-IGA = 1 I-IGA = 0 I-IGA = 0 IGA: Investigator’s Global Assessment; I-IGA: intertriginous-IGA 11 Pr

  12. Slide 12: Roflumilast Safety and Tolerability Were Similar to Vehicle

    Roflumilast Safety and Tolerability Were Similar to Vehicle DERMIS-1 DERMIS-2 • Roflumilast cream demonstrated low rates of application site AEs, Roflumilast Roflumilast treatment-related AEs, and cream Vehicle cream Vehicle discontinuations due to AEs, 0.3% (n=153) 0.3% (n=152) comparable to vehicl

  13. Slide 13: Conclusions

    Conclusions • Once-daily roflumilast cream demonstrated robust and clinically meaningful efficacy based on IGA Success at the primary endpoint of 8 weeks – Results were reproducible across both phase 3 studies • Roflumilast cream demonstrated statistically superior efficacy versus vehicle in patient

  14. Slide 14: Disclosures

    Disclosures Mark Lebwohl is an investigator and/or consultant for AbbVie, Aditum Bio, Allergan, Inc., Almirall, AltruBio Inc., Amgen, AnaptysBio, Arcutis, Inc., Aristea Therapeutics, Arrive Technologies, Avotres, Inc., BiomX Ltd., BirchBioMed, BMD Skincare, Inc., Boehringer Ingelheim, Bristol-Myers

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