Arcutis Biotherapeutics, Inc. · NASDAQ:ARQT

Arcutis Biotherapeutics — Technical Presentation (March 2020)

15 slides from Arcutis Biotherapeutics's technical presentation, March 2020

  1. Slide 1: ARQ-151, Roflumilast Cream, Improved Chronic Plaque Psoriasis in Phase 2b Study

    ARQ-151, Roflumilast Cream, Improved Chronic Plaque Psoriasis in Phase 2b Study Mark G. Lebwohl1, Kim A. Papp2, Linda Stein Gold3, Melinda J. Gooderham4, Leon H. Kircik5, Zoe D. Draelos6, Steven E. Kempers7, Mathew Zirwas8, Kathleen Smith9, David W. Osborne9, Marie-Louise Trotman10, Lynn Navale9, Ch

  2. Slide 2: Disclosures

    Disclosures L. Stein Gold is an investigator for AbbVie, Arcutis, Celgene, Dermavant, Eli Lilly, LEO Pharma, Novartis, and Ortho Dermatologics; serves as an advisor for Celgene, Dermavant, LEO Pharma, Novartis, and Ortho Dermatologics; and is a speaker for LEO Pharma and Ortho Dermatologics. M.G. Le

  3. Slide 3: Treatment of Chronic Plaque Psoriasis

    Treatment of Chronic Plaque Psoriasis Background • High-potency corticosteroids and vitamin D derivatives are the main treatments, but have long-term tolerability issues – Sensitive areas such as the face and intertriginous areas require additional considerations • PDE-4 activity is elevated in psor

  4. Slide 4: Safety and Efficacy of Topical Once-Daily Roflumilast Cream: Objective and Methods

    Safety and Efficacy of Topical Once-Daily Roflumilast Cream in Subjects With Chronic Plaque Psoriasis: Objective and Methods Patients randomized Objective N=331 • Evaluate the safety and efficacy of 2 doses of Patients randomized roflumilast cream versus vehicle in error (n=1) Methods Roflumilast cr

  5. Slide 5: Baseline Characteristics

    Baseline Characteristics Roflumilast Roflumilast Roflumilast Roflumilast 0.3% 0.15% Vehicle 0.3% 0.15% Vehicle (n=109) (n=113) (n=109) (n=109) (n=113) (n=109) 55.5 PASI, mean score (SD) 7.7 (3.6) 8.0 (3.9) 7.6 (3.1) Age, mean years (SD) 51.7 (14.1) 54.4 (14.2) (13.5) WI-NRS, mean score (SD) 6.1 (2.7

  6. Slide 6: Primary Endpoint of IGA 'Clear' or 'Almost Clear' at Week 6 Was Met

    Primary Endpoint of IGA ‘Clear’ or ‘Almost Clear’ at Week 6 Was Met for Both Roflumilast Cream Doses Subjects Achieving IGA of ‘Clear’ or ‘Almost Clear’ at Week 6 P<0.001 40 35 P=0.004 30 Subjects, % (95% CI) 25 20 15 10 5 0 Roflumilast 0.3% (n=109) Roflumilast 0.15% (n=113) Vehicle (n=109) Data are

  7. Slide 7: Roflumilast Cream Improved Severity of Chronic Plaque Psoriasis as Measured by IGA Success

    Roflumilast Cream Improved Severity of Chronic Plaque Psoriasis as Measured by IGA Success Subjects Achieving IGA of ‘Clear’ or ‘Almost Clear’ Plus 2-Grade Improvement From Baseline 45 P<0.001 P=0.002 40 P=0.005 P=0.013 P=0.002 35 Subjects, % (95% CI) P=0.038 30 25 20 15 10 5 0 Week 2 Week 4 Week 6

  8. Slide 8: Roflumilast Cream Led to Early Improvement in PASI

    Roflumilast Cream Led to Early Improvement in Chronic Plaque Psoriasis Area and Severity Index PASI 0 LS Mean Change From Baseline, % (95% CI) -10 -20 * -30 * * -40 * * * -50 * -60 * * * -70 Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Roflumilast 0.3% (n=109) Roflumilast 0.15% (n=113) Vehicle (n=10

  9. Slide 9: Roflumilast Cream Improved Severity of Plaque Psoriasis

    Roflumilast Cream Improved Severity of Plaque Psoriasis Roflumilast 0.3% Roflumilast 0.15% Vehicle IGA = 3 IGA = 3 IGA = 3 Baseline IGA = 1 IGA = 1 IGA = 3 Week 8 IGA: Investigator Global Assessment. 9 PRESENTED AT THE AMERICAN ACADEMY OF DERMATOLOGY ANNUAL MEETING, MARCH 20-24, 2020, DENVER, CO, US

  10. Slide 10: Intertriginous Plaques Achieving I-IGA Success by Week 6

    Most Subjects With Intertriginous Plaques Treated With Roflumilast Cream Achieved I-IGA Success by Week 6 With Continued Improvement Through Week 12 Subjects With Intertriginous Plaques Achieving I-IGA of ‘Clear’ or ‘Almost Clear’ Plus 2-Grade Improvement From Baseline I-IGA Status of P=0.001 P=0.00

  11. Slide 11: Roflumilast Cream Rapidly Improved Subject-Reported Itch

    Roflumilast Cream Rapidly Improved Subject-Reported Itch Subjects Achieving 4-Point Reduction in WI-NRS* P<0.001 90 P=0.034 P<0.001 P=0.01 80 P=0.002 P=0.012 70 Subjects, % (95% CI) 60 P=0.034 50 40 30 20 10 0 Week 2 Week 4 Week 6 Week 8 Week 12 Roflumilast 0.3% (n=71) Roflumilast 0.15% (n=62) Vehic

  12. Slide 12: Roflumilast Cream Rapidly Reduced Patient-Reported Burden of Disease

    Roflumilast Cream Rapidly Reduced Patient-Reported Burden of Disease Total PSD Score 80 *P<0.001 vs vehicle 70 † P=0.002 vs vehicle Mean Total PSD Score (95% CI) ‡ P=0.01 vs vehicle 60 50 40 ‡ † * 30 † * * * 20 * * Baseline Week 2 Week 4 Week 6 Week 8 Week 12 Roflumilast 0.3% (n=109) Roflumilast 0.1

  13. Slide 13: Most TEAEs Were Mild or Moderate

    Most TEAEs Were Mild or Moderate • Treatment-related AEs were uncommon Roflumilast Roflumilast and were similar across groups 0.3% 0.15% Vehicle TEAE, n (%) (n=109) (n=110) (n=107) • More subjects discontinued the study Subjects with any TEAE 42 (38.5) 30 (27.3) 32 (29.9) due to an AE in the vehicle

  14. Slide 14: Conclusions

    Conclusions • PDE-4 inhibition is a validated mechanism of action for oral psoriasis therapy, but new for topical psoriasis treatment • Roflumilast once-daily cream demonstrated significant improvements in psoriasis signs and symptoms – Statistically significant increase in IGA ‘clear’/’almost clear

  15. Slide 15: Acknowledgements

    Acknowledgements • Thank you to the investigators and their staff for their participation in this trial • David Adam, Ajax, Ontario, Canada; Lorne Albrecht, Surrey, British Columbia, Canada; Javier Alonso-Llamazares, Miami, Florida; Suzanne Bruce, Houston, Texas; Laura Ferris, Pittsburgh, Pennsylvan

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