Ucb S.a. · EURONEXT:UCB
Ucb — 31st EADV Congress 2022
40 slides from Ucb's conference presentation, September 2022
Slide 1: UCB Virtual Briefing: Bimekizumab in Moderate to Severe Plaque Psoriasis
UCB VIRTUAL BRIEFING: Bimekizumab in Moderate to Severe Plaque Psoriasis: Data Presented at the 31st EADV Congress Bimekizumab is approved for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy in the European Union and Great Britain. The label information may diff
Slide 2: Disclaimer and safe harbor
Disclaimer and safe harbor This presentation contains forward-looking statements, including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking st
Slide 3: Introduction
Proprietary and Confidential Property of UCB Introduction Emmanuel Caeymaex Executive Vice President Immunology Solutions & Head of U.S. GL-N-BK-PSO-2200109 Date of preparation: September 2022 3
Slide 4: Agenda
Antje Witte WELCOME Head of Investor Relations, UCB Emmanuel Caeymaex Executive Vice President INTRODUCTION Immunology Solutions & Head of U.S. 3-year responder analysis from the BE BRIGHT open-label extension study Professor Bruce Proprietary and Confidential Property of UCB Strober Yale University
Slide 5: BIMZELX is the first IL-17A and IL-17F inhibitor approved for plaque psoriasis
BIMZELX®▼(bimekizumab) is the first IL-17A and IL-17F inhibitor approved for the treatment of moderate to severe plaque psoriasis CA FEB Pre-filled Syringe 20224 EU Product and GB Packaging Only AUG 20212 EU AUG JP Proprietary and Confidential Property of UCB 20211 Jan 20223 AUS KSA MAR Pre-filled P
Slide 6: Bimekizumab demonstrated speed, depth and durability of response
In Phase 3 clinical studies bimekizumab demonstrated speed, depth and durability of response Magnitude of response Patients with moderate- to-severe plaque Proprietary and Confidential Property of UCB psoriasis place a high ~6 out of 10 patients achieved PASI 100 at Week 16 2,3,4 value on treatment
Slide 7: Bimekizumab can achieve completely clear skin after inadequate response to other treatments
Bimekizumab can achieve completely clear skin after an inadequate response to other treatments PASI 100 with bimekizumab in patients with an inadequate response to secukinumab, ustekinumab or adalimumab PASI 90 (post hoc analyses) BE SURE (NRI)1 BE BRIGHT (NRI)2 BE RADIANT (NRI)3 % patients with PAS
Slide 8: P1491: Maintenance of response through three years, BE BRIGHT
P1491 Proprietary and Confidential Property of UCB Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension Bruce Strober, Yayoi Tada, Ulrich Mrowietz, Mark Lebwohl, Peter Fo
Slide 9: Study design and presentation objective
Study design and presentation objective Presentation Objective: To evaluate maintenance of response over three years among patients with moderate to severe plaque psoriasis who had an initial Proprietary and Confidential Property of UCB efficacy response after 16 weeks’ BKZ treatment and entered the
Slide 10: PASI 100 responders maintained response through 3 years
Over 8 out of 10 BKZ-treated patients who achieved PASI 100 at week 16 maintained response through 3 years Week 16 PASI 100 response rate Proport ion of Week 16 PASI 100 BKZ Total (mNRI; N=503) responders wit h PASI 100 respo nse (%) BKZ 320 mg Q4W/Q8W (mNRI; N= 147) in BKZ-randomised patients (N=98
Slide 11: PASI ≤2 responders maintained response through 3 years
Over 9 out of 10 BKZ-treated patients who achieved PASI≤2 at week 16 maintained response through 3 years Week 16 PASI ≤2 response rate Proportion of Week 16 PASI≤2 BKZ Total (mNRI; N=694) responders with PASI≤2 respo nse ( %) BKZ 320 mg Q4W/Q8W (mNRI; N=189) in BKZ-randomised patients (N=989) 100 98
Slide 12: PASI 100 responders achieved DLQI 0/1 through 3 years
Over 8 out of 10 BKZ-treated patients who achieved PASI 100 at week 16 achieved DLQI 0/1 through 3 years Week 16 PASI 100 response rate Proport ion of Week 16 PASI 100 BKZ Total (mNRI; N=330) responders wit h DLQI 0/ 1 respo nse ( %) BKZ 320 mg Q4W/Q8W (mNRI; N= 147) in BKZ-randomised patients (N=98
Slide 13: Conclusions
Conclusions Maintenance of Week 16 responses at Year 3 (OLE Week 96) Proprietary and Confidential Property of UCB 94.2% 90.8% 82.0% 88.0% BKZ total (mNRI) PASI ≤2 in BSA ≤1% in PASI 100 in DLQI 0/1 in PASI ≤2 responders BSA ≤ 1% responders PASI 100 responders PASI 100 responders (N=694) (N=597) (N=5
Slide 14: P1572: Efficacy and safety through three years, BE SURE and BE BRIGHT
P1572 Proprietary and Confidential Property of UCB Bimekizumab efficacy and safety through three years in patients with moderate to severe plaque psoriasis: Long-term results from the BE SURE randomised controlled trial and the BE BRIGHT open-label extension Diamant Thaçi, Ron Vender, Menno de Rie,
Slide 15: BE SURE/BE BRIGHT study design and presentation objective
BE SURE/BE BRIGHT study design and presentation objective Presentation Objective: To evaluate the long-term efficacy and safety of BKZ over three years in patients with moderate to severe plaque psoriasis who Proprietary and Confidential Property of UCB enrolled in the BE SURE phase 3 trial and ente
Slide 16: Patients achieving PASI 100 up to 152 weeks
Over 6 out of 10 BKZ-treated patients achieved PASI 100 up to 152 weeks (mNRI) Proportion of patients achieving 100 Proprietary and Confidential Property of UCB 75.8% 69.2% 75 71.3% PASI 100 (%) 62.8% 74.0% 67.5% 50 62.3% 26.0% 25 Open-label period with possible dose adjustments 0 0 8 16 24 32 40 48
Slide 17: Patients achieving PASI 90 up to 152 weeks
Over 8 of 10 BKZ-treated patients achieved PASI 90 up to 152 weeks (mNRI) 97.1% Proport ion of pat ient s achieving 100 94.3% 96.1% 75 89.4% 87.3% Proprietary and Confidential Property of UCB PASI 90 (%) 89.6% 89.0% 50 50.1% 25 Open-label period with possible dose adjustments 0 0 8 16 24 32 40 48 56
Slide 18: Patients achieving DLQI 0/1 up to 152 weeks
Over 7 out of 10 BKZ-treated patients achieved DLQI 0/1 up to 152 weeks (mNRI) Proportion of patients achieving 100 Proprietary and Confidential Property of UCB 81.9% 82.1% 81.4% 81.0% 82.0% 78.0% 75 66.6% DLQI 0/1 (%) 50 48.1% 25 Open-label period with possible dose adjustments 0 0 8 16 24 32 40 48
Slide 19: Overview of adverse events, Weeks 104–152
Overview of adverse events during BKZ treatment in patients from BE SURE who entered BE BRIGHT, Weeks 104–152 EAIR/100 PY (95% BKZ Total BKZ Q4W/Q4W BKZ Q4W/Q8W ADA/BKZ Q4W CI) N=380 N=132 N=124 N=124 Any TEAE 101.7 (88.7, 116.0) 108.8 (85.5, 134.6) 99.4 (77.6, 125.4) 97.6 (76.2, 123.1) Serious TEAE
Slide 20: Conclusions
Conclusions Clinical and health-related quality of life responses observed during the first two years of treatment were sustained to three years of treatment, regardless of BKZ maintenance dose frequency prior to the third year Proprietary and Confidential Property of UCB Additionally, responses wer
Slide 21: P1569: Pooled safety analysis up to three years
P1569 Proprietary and Confidential Property of UCB Bimekizumab safety in patients with moderate to severe plaque psoriasis: Analysis of pooled data from up to three years of treatment in phase 2 and 3 clinical trials Kenneth B. Gordon, Richard G. Langley, Richard B. Warren, Yukari Okubo, David Rosma
Slide 22: Introduction and presentation objective
Introduction and presentation objective Presentation Number: P1569 Objective: Methods: To report long-term safety data, pooled to include three • Long-term safety data were evaluated for all patients who years of treatment, in patients with moderate to severe received ≥1 dose of BKZ in four phase 3
Slide 23: Baseline characteristics
Baseline characteristics Baseline demographics were similar between BKZ dose groups Phase 2 and 3 Phase 3 BKZ Totala BKZ 320 mg Q4W BKZ 320 mg Q8W BKZ totala N=1,789 N=1,456 N=1,289 N=1,495 Age (years), mean ± SD 45.2 ± 13.5 45.4 ± 13.5 45.5 ± 13.3 45.4 ± 13.4 Male, n (%) 1,252 (70.0) 1,042 (71.6) 9
Slide 24: Treatment exposure and most common TEAEs
Summary of treatment exposure, summary of TEAEs and most common TEAEs in BKZ-treated patients in the Phase 2 and 3 trials TEAEs over TEAEs over TEAEs over 3 years 2 years 3 years Phase 2 and 3 Phase 2 and 3 Phase 3 • Safety data observed BKZ Totala BKZ totala BKZ 320 mg Q4W BKZ 320 mg Q8W BKZ totala
Slide 25: TEAEs of interest in BKZ-treated patients
TEAEs of interest in BKZ-treated patients in the Phase 2 and 3 trials TEAEs over TEAEs over TEAEs over 3 years 2 years 3 years Phase 2 and 3 Phase 2 and 3 Phase 3 BKZ Totala BKZ totala BKZ 320 mg Q4W BKZ 320 mg Q8W BKZ totala N=1,789 N=1,789 N=1,456 N=1,289 N=1,495 • The rates of TEAEs of interest r
Slide 26: Exposure adjusted incidence rates of TEAEs did not increase
Exposure adjusted incidence rates of TEAEs did not increase compared with data from 2 years of treatment All TEAEs Serious TEAEs Oral candidiasis TEAEs 35 10 9 6.6 30 (5.5, 7.9) 238.0 8 5.9 EAIR/ 100 PY EAIR/ 100 PY (5.1, 6.9) 5.6 25 (226.0, 250.5) 202.4 7 (4.9, 6.4) 16.4 250 (192.6, 212.6) 186.1 (1
Slide 27: P1478: Two-year scalp and nail efficacy after switching
P1478 Bimekizumab efficacy over two years in patients Proprietary and Confidential Property of UCB with moderate to severe plaque psoriasis with scalp and nail involvement who switched from adalimumab, ustekinumab, or secukinumab: Results from the BE SURE, BE VIVID, BE BRIGHT, and BE RADIANT phase 3
Slide 28: Psoriatic lesions in visible areas impact quality of life
Psoriatic lesions in highly visible areas, such as the scalp and nails, disproportionally impact patients’ health-related quality of life1 1. Augustin M et al. Br J Dermatol 2019;181:358–65.IGA. GL-N-BK-PSO-2200109 Date of preparation: September 2022 28
Slide 29: Study design and presentation objective
Study design and presentation objective Objective: To evaluate scalp and nail outcomes over two years in patients with moderate to severe plaque psoriasis who switched to BKZ from ADA, UST, or SEC. Proprietary and Confidential Property of UCB Only active-comparator treatment groups in BE SURE, BE VI
Slide 30: Patient disposition
Patient disposition Proportion of patients who had Baseline: Comparator treatment period: not achieved complete nail or scalp Patients with moderate to severe scalp Patients who did not achieve complete nail clearance at switch to BKZ (OC): or nail involvement or scalp clearance Nail Scalp Adalimuma
Slide 31: mNAPSI 0 response after switch to BKZ
A high proportion of patients who did not achieve mNAPSI 0 with ADA, UST or SEC achieved complete clearance 24 weeks after switch to BKZ Proportion of mNAPSI 0 non-responders who achieved mNAPSI 0 after switch to BKZ (mNRI) ADA/BKZ (N=36) UST/BKZ (N=32) SEC/BKZ (N=33) Proprietary and Confidential Pr
Slide 32: Scalp IGA 0 response after switch to BKZ
A high proportion of patients who did not achieve scalp IGA 0 with ADA, UST or SEC achieved complete clearance 24 weeks after switch to BKZ Proportion of scalp IGA 0 non-responders who achieved scalp IGA 0 after switch to BKZ (mNRI) ADA/BKZ (N=33) UST/BKZ (N=31) SEC/BKZ (N=42) 100 83.9% Proprietary
Slide 33: Conclusions
Conclusions High proportions of patients who did not achieve mNAPSI 0 or scalp IGA 0 with ADA, UST or SEC demonstrated substantial improvements in complete clearance 24 weeks after switching to BKZ Proprietary and Confidential Property of UCB Results were generally maintained across a BKZ treatment
Slide 34: BE VIVID scalp IGA improvement over 52 weeks
BE VIVID scalp IGA improvement over 52 weeks Week 0 Week 16 Week 52 sIGA = Moderate sIGA = Clear (0) sIGA = Clear (0) IGA: Investigator’s Global Assessment GL-N-BK-PSO-2200109 Date of preparation: September 2022
Slide 35: mNAPSI improvement in BE VIVID and BE RADIANT
BE VIVID mNAPSI improvement over 52 weeks Week 0 Week 16 Week 52 mNAPSI = 22 mNAPSI = 20 mNAPSI = 0 BE RADIANT mNAPSI improvement over 16 weeks Week 0 Week 2 Week 16 mNAPSI = 21 Not reported mNAPSI = 8 mNAPSI: modified Nail Psoriasis Severity Index; mNAPSI 0: an mNAPSI score of 0. GL-N-BK-PSO-220010
Slide 36: Summary
Proprietary and Confidential Property of UCB Summary Emmanuel Caeymaex Executive Vice President Immunology Solutions & Head of U.S. GL-N-BK-PSO-2200109 Date of preparation: September 2022 36
Slide 37: Summary
Summary Patients place a high 3-year efficacy 3-year safety High Impact Areas: value on treatments Switch which provide: Proprietary and Confidential Property of UCB Over six out of 10 patients Bimekizumab was well A high proportion of adalimumab, Speed, depth and achieved PASI 100 up to tolerated w
Slide 38: Q&A
Professor Bruce Strober Proprietary and Confidential Property of UCB Yale University, Connecticut, U.S. Q&A Professor Richard Warren Salford Royal NHS Foundation Trust and The University of Manchester, UK Emmanuel Caeymaex Executive Vice President Immunology Solutions and Head of US, UCB GL-N-BK-PSO
Slide 39: Thank you
Thank you 39 Proprietary and Confidential Property of UCB
Slide 40: Proprietary and Confidential Property of UCB
Proprietary and Confidential Property of UCB Proprietary and Confidential Property of UCB 40