Ucb S.a. · EURONEXT:UCB
Ucb — Technical Presentation (November 2022)
40 slides from Ucb's technical presentation, November 2022
Slide 1: UCB Virtual Briefing: 52-week data from bimekizumab Phase 3 studies
UCB VIRTUAL BRIEFING: 52-week data from bimekizumab Phase 3 Studies in Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA) Bimekizumab is not approved for use in nr-axSpA, AS or PsA by any regulatory authority worldwide. The safety and efficacy of bimekizumab in nr-axSpA, AS and PsA have n
Slide 2: Intended Audience
Intended Audience • This presentation is intended for analysts, investors and U.S. medical/trade journalists invited by UCB to this closed educational event. • The efficacy and safety of investigational bimekizumab in the treatment of psoriatic arthritis (PsA), non-radiographic axial spondyloarthrit
Slide 3: 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 4: Introduction
Proprietary and Confidential Property of UCB Emmanuel Caeymaex Introduction Executive Vice President, Immunology Solutions and Head of US, UCB Bimekizumab is not approved for use in nr-axSpA, AS or PsA by any regulatory authority worldwide. The safety and efficacy of bimekizumab in nr-axSpA, AS and
Slide 5: Agenda
01 Introduction Emmanuel Caeymaex Executive Vice President, Immunology Solutions and Head of US, UCB 02 Overview: Bimekizumab Phase 3 studies in axSpA and PsA Dr. John Ioannou Head of Medical Affairs, Rheumatology, UCB Proprietary and Confidential Property of UCB 03 Psoriatic Arthritis: 52-week data
Slide 6: Bimekizumab has delivered consecutive positive Phase 3 studies in IL-17 mediated diseases
In IL-17 mediated diseases, bimekizumab has delivered 8 consecutive positive Phase 3 studies to-date Psoriasis BE VIVID (PS0009) NCT03370133 (vs ustekinumab*) Psoriatic Arthritis BE READY (PS0013) BE OPTIMAL (PA0010) Proprietary and Confidential Property of UCB NCT03410992 (vs placebo) NCT03895203 (
Slide 7: Bimzelx approved for psoriasis by seven regulatory authorities
Bimekizumab, marketed under the tradename BIMZELX®▼, is now approved for psoriasis by seven regulatory authorities worldwide GREAT BRITAIN Proprietary and Confidential Property of UCB AUG212 CANADA EU SWITZERLAND FEB224 AUG211 OCT227 JAPAN JAN223 SAUDI ARABIA JUL226 Bimekizumab is approved for moder
Slide 8: Overview: Bimekizumab Phase 3 studies in axSpA and PsA
Proprietary and Confidential Property of UCB Overview: Bimekizumab Dr. John Ioannou Phase 3 studies in axSpA BMedSci, MB BS, PhD, FRCP and PsA Head of Medical Affairs, Rheumatology, UCB Bimekizumab is not approved for use in nr-axSpA, AS or PsA by any regulatory authority worldwide. The safety and e
Slide 9: PsA and axSpA have many overlapping clinical features
PsA and axSpA have many overlapping clinical features Treatment goals and reality Proprietary and Confidential Property of UCB Guidelines recommend treatment should be aimed at reaching the target of remission, or low disease activity19,20,21* Approximately one third of patients achieve these goals
Slide 10: Phase 3 program in PsA and axSpA has high threshold endpoints
The Phase 3 clinical development program in PsA and axSpA has high threshold endpoints aimed at elevating standards of care Phase 3 studies BE OPTIMAL1 BE COMPLETE2 Phase 3 double-blind study in patients with Phase 3 double-blind study in patients with active PsA who were biologic naive active PsA w
Slide 11: Complete skin clearance across psoriasis studies
In Phase 3 psoriasis studies, bimekizumab consistently demonstrated high levels of complete skin clearance across studies PASI100 during Year 1 with bimekizumab vs active comparators (NRI) BE VIVID 1 BE SURE 2,3 BE RADIANT †4,5 Proprietary and Confidential Property of UCB In BE SURE, PASI100 at Week
Slide 12: Psoriatic Arthritis and Axial Spondyloarthritis 52-week data
Psoriatic Arthritis: 52-week data from BE OPTIMAL Philip Mease MD, MACR Director, Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health Axial Spondyloarthritis: Clinical Professor, University of Washington 52-week data from BE MOBILE 1 and School of Medicine Seattle, WA, USA BE
Slide 13: BE OPTIMAL 52-Week Efficacy and Safety Results
L02 Bimekizumab Treatment in Biologic DMARD-Naïve Proprietary and Confidential Property of UCB Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study Christopher T. Ritchlin, Laura C. Coates, Iain B. McInne
Slide 14: Disclosures & Acknowledgements
Disclosures & Acknowledgements Disclosures CTR: Research: AbbVie, Amgen, and UCB Pharma; consultant for Amgen, AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma. LCC: Grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma;
Slide 15: Background and objective
Background and objective Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Results (up to week 24) from the pivotal phase 3 study, BE OPTIMAL, and results (up to 152 weeks) from the phase 2b Proprietary and Confidential Property of UCB st
Slide 16: BE OPTIMAL Study Design
BE OPTIMAL Study Design Screening Double-blind period Active treatment-blind period Extension study, n=281 BE VITAL Placebo Bimekizumab 160 mg Q4W (NCT04009499), to evaluate response to treatment and long-term safety 2:3:1 n=431 N=852 Bimekizumab 160 mg Q4W Safety follow-up visit 20 weeks after last
Slide 17: Patient Demographics and Baseline Disease Characteristics
Patient Demographics and Baseline Disease Characteristics Reference Arm Placebo BKZ 160 mg Q4W (ADA 40 mg Q2W) n=281 n=431 n=140 Age, years, mean (SD) 48.7 (11.7) 48.5 (12.6) 49.0 (12.8) Sex, male, n (%) 127 (45.2) 201 (46.6) 71 (50.7) BMI, kg/m2, mean (SD) 29.6 (6.1) 29.2 (6.8) 28.4 (5.9) PsA durat
Slide 18: Patient Disposition to Week 52
Patient Disposition to Week 52 Screen Failed (N=306) 89.3% completed Week 52; • Ineligibility (n=247) low number of Enrollment Screened N=1158 • Withdrawal of consent (n=30) • Other (n=25) discontinuations due to • Lost to follow-up (n=4) TEAEs or lack of efficacy Randomized N=852 Baseline Reference
Slide 19: Joint and Skin Responses were Sustained to Week 52
Joint and Skin Responses were Sustained to Week 52 (NRI) ACR50 PASI100a 100 100 Double-blind period Active treatment-blind period Double-blind period Active treatment-blind period 80 80 Δ = 45.4 Δ = 33.9 Nominal p<0.001 65.0% p<0.001 60.8% Patients (%) 60 54.5% 60 53.0% 50.0% 48.5% 45.7% 47.5% 43.9%
Slide 20: Joint Responses were Sustained to Week 52
Joint Responses were Sustained to Week 52 (NRI) ACR20 ACR50 ACR70 100 100 100 Double-blind Active treatment-blind Double-blind Active treatment-blind Double-blind Active treatment-blind period period period period period period Nominal 80 p<0.001 BKZ 80 80 72.9% vs PBO 68.6% 71.2% at Week 16 68.0% P
Slide 21: Skin Responses were Sustained to Week 52
Skin Responses were Sustained to Week 52 (NRI) PASI75 PASI90 PASI100 100 100 100 Double-blind Active treatment-blind Double-blind Active treatment-blind Double-blind Active treatment-blind period period period period period period 85.0% 80 77.4% 81.6% 80 80 75.7% p<0.001 BKZ 71.4% Nominal 66.2% vs P
Slide 22: Sustained Improvements in MDA to Week 52
Sustained Improvements in MDA to Week 52 (NRI) MDA response defined as Double-blind period Active treatment-blind period achievement of at least 5 of the 7 100 following criteria: • Tender joint count ≤1 80 • Swollen joint count ≤1 • Psoriasis Area and Severity Index p<0.001 ≤1a or body surface area
Slide 23: Bimekizumab Inhibited Radiographic Progression to Week 52
Bimekizumab Treatment Inhibited Radiographic Progression to Week 52 (OC) Week 0–16 No Radiographic Progression 15 PBO; n=251 (vdHmTSS CfB ≤0.5) 12 BKZ 160 mg Q4W; n=392 Double-blind period Active treatment-blind period 9 Reference Arm (ADA 40 mg Q2W; n=117) vdHmTSS CfB 100 94.0% 94.1% 6 91.3% 88.8%
Slide 24: Adverse Events to Week 16 and Week 52
Adverse Events to Week 16 and Week 52 Week 0–16 Week 0–52 Placebo BKZ 160 mg Q4W Reference Arm BKZ 160 mg Q4W Total Reference Arm n (%) n=281 n=431 (ADA 40 mg Q2W) n=140 n=702a (ADA 40 mg Q2W) n=140 Any TEAE 139 (49.5) 257 (59.6) 83 (59.3) 555 (79.1) 113 (80.7) Serious TEAEs 3 (1.1) 8 (1.9) 2 (1.4)
Slide 25: Summary
Summary Proprietary and Confidential Property of UCB The phase 3 BE OPTIMAL Bimekizumab-treated Bimekizumab treatment Bimekizumab was study demonstrated patients with PsA inhibited radiographic generally well-tolerated, long-term response of IL- demonstrated response progression to Week 52. and the
Slide 26: BE MOBILE 52-Week Results in nr-axSpA and AS
Poster L14 (Ignite Talk) Proprietary and Confidential Property of UCB Bimekizumab Maintains Improvements in Efficacy Endpoints and has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3
Slide 27: Introduction
Introduction Objective Methods Proprietary and Confidential Property of UCB To report efficacy and safety of • BE MOBILE 1 (NCT03928704; nr-axSpA) and 2 (NCT03928743; AS) were bimekizumab (BKZ) in patients with conducted in parallel; each comprised a 16-week double blind, PBO- controlled period foll
Slide 28: Study Designs
Study Designs Proprietary and Confidential Property of UCB Patients were eligible to receive non-biologic rescue therapy from Week 20 at the discretion of the investigator, while continuing to receive BKZ. All patients had active nr-axSpA or AS at baseline (BASDAI ≥4 and spinal pain ≥4). a Included
Slide 29: Baseline Characteristics
Baseline Characteristics BE MOBILE 1 BE MOBILE 2 (nr-axSpA) (AS) N=254 N=332 Age, mean (SD) 39.4 (11.5) 40.4 (12.3) Sex, male, n (%) 138 (54.3) 240 (72.3) Proprietary and Confidential Property of UCB HLA-B27 positive, n (%) 197 (77.6) 284 (85.5) Symptom duration, years, mean (SD) 9.0 (8.8) 13.5 (10.
Slide 30: Sustained ASAS40 Response to Week 52
Sustained ASAS40 Response to Week 52 BE MOBILE 1 BE MOBILE 2 nr-axSpA (NRI) AS (NRI) Proprietary and Confidential Property of UCB Missing data were imputed using NRI. Randomized set. p values were calculated using logistic regression with treatment, prior MRI/CRP status (BE MOBILE 1) or TNFi exposur
Slide 31: Sustained Clinical Responses to Week 52
BE MOBILE 1 BE MOBILE 2 Sustained Clinical (nr-axSpA) (AS) Responses to Week 52 PBO → BKZ WEEK 52 BKZ 160 mg PBO → BKZ WEEK 52 BKZ 160 mg Across the Spectrum of 160 mg Q4W N=126 Q4W N=128 160 mg Q4W N=111 Q4W N=221 Disease ASAS40* [NRI], n (%) 64 (50.8) 78 (60.9) 76 (68.5) 129 (58.4) ASAS40 in TNFi-
Slide 32: ASDAS States Over Time
ASDAS States BE MOBILE 1 Over Time At week 52, in the continued bimekizumab arm 61.6% nr-axSpA patients and 57.1% AS patients achieved ASDAS<2.1 Proprietary and Confidential Property of UCB BE MOBILE 2 Data reported using MI where patients that discontinued treatment due to loss of efficacy or safet
Slide 33: Reductions in MRI were Sustained through Week 52
Reductions in MRI were Sustained through Week 52 SPARCC MRI SIJ score CfB BE MOBILE 1 BE MOBILE 2 SPARCC MRI SIJ score CfB, nr-axSpA (OC)a,b SPARCC MRI SIJ score CfB, AS (OC)a,e Proprietary and Confidential Property of UCB Data reported using OC. Randomized set. Tables report mean absolute values. a
Slide 34: Adverse Event Overview
Adverse Event BE MOBILE 1 BE MOBILE 2 Overview (nr-axSpA) (AS) n (%) [EAIR] BKZ 160 mg Q4W BKZ 160 mg Q4W Totala Totala n=244 n=330 Any TEAE 183 (75.0) [202.1] 249 (75.5) [200.8] Most frequently reported TEAEsb Nasopharyngitis 30 (12.3) [15.7] 30 (9.1) [11.0] Proprietary and Confidential Property of
Slide 35: Summary
Across the full axSpA disease spectrum, dual inhibition of Proprietary and Confidential Property of UCB IL-17F in addition to IL-17A with bimekizumab resulted in sustained response, including suppression of inflammation Summary and improvements in function and quality of life, to Week 52. No new saf
Slide 36: Summary
Proprietary and Confidential Property of UCB Emmanuel Caeymaex Summary Executive Vice President, Immunology Solutions and Head of US, UCB GL-N-BK-axSpA-2200111 Date of preparation: November 2022 36
Slide 37: Summary
Summary • Within six months of taking a biologic, the majority of patients with PsA and axSpA do not achieve Patient needs remission or low disease activity*1,2 • In both Phase 3 studies, a greater proportion of bimekizumab patients achieved high levels of Bimekizumab joint and skin clearance vs pla
Slide 38: Q&A
Emmanuel Caeymaex Executive Vice President, Immunology Solutions and Head of US, UCB Proprietary and Confidential Property of UCB Q&A Dr. John Ioannou Head of Medical Affairs, Rheumatology, UCB Philip Mease MD, MACR Director, Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health
Slide 39: Thank you
Proprietary and Confidential Property of UCB Thank you GL-N-BK-axSpA-2200111 Date of preparation: November 2022 39
Slide 40: Proprietary and Confidential Property of UCB
GL-N-BK-axSpA-2200111 Proprietary and Confidential Property of UCB Date of preparation: November 2022