Ucb S.a. · EURONEXT:UCB
Ucb — Technical Presentation (March 2023)
32 slides from Ucb's technical presentation, March 2023
Slide 1: UCB Virtual Briefing
UCB VIRTUAL BRIEFING Data from the bimekizumab Phase 3 Studies in Hidradenitis Suppurativa (HS) BE HEARD I and BE HEARD II Bimekizumab is not approved for use in HS by any regulatory authority worldwide. The safety and efficacy of bimekizumab in HS has not been established. Bimekizumab is not approv
Slide 2: Intended Audience
Intended Audience • This presentation is intended for analysts and investors invited by UCB to this closed educational event. • The efficacy and safety of investigational bimekizumab in the treatment of hidradenitis suppurativa (HS) has not been established and it is not approved for the treatment o
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 Introduction Emmanuel Caeymaex Executive Vice President, Immunology Solutions and Head of US, UCB Bimekizumab is not approved for use in HS by any regulatory authority worldwide. The safety and efficacy of bimekizumab GL-N-BK-HS-2300006 4 in HS has not be
Slide 5: Agenda
01 Introduction Emmanuel Caeymaex Executive Vice President, Immunology Solutions and Head of US, UCB 02 Hidradenitis Suppurativa: A Need for New Therapeutic Approaches Proprietary and Confidential Property of UCB Amit Garg, M.D. Professor & Founding Chair, Department of Dermatology, Zucker School of
Slide 6: In IL-17 mediated diseases, bimekizumab has delivered consecutive positive Phase 3 studies
In IL-17 mediated diseases, bimekizumab has delivered 10 consecutive positive Phase 3 studies Psoriasis BE VIVID (PS0009) NCT03370133 (vs ustekinumab*) Psoriatic Arthritis BE READY (PS0013) BE OPTIMAL (PA0010) NCT03410992 (vs placebo) NCT03895203 (vs placebo) Proprietary and Confidential Property of
Slide 7: Our focus in HS is aligned with our purpose
Our focus in HS is aligned with our purpose Proprietary and Confidential Property of UCB Supported by our Partnership Network Including Bimekizumab is not approved for use in HS by any regulatory authority worldwide. The safety and efficacy of bimekizumab GL-N-BK-HS-2300006 7 in HS has not been esta
Slide 8: Hidradenitis Suppurativa: A Need for New Therapeutic Approaches
Amit Garg, M.D. Proprietary and Confidential Property of UCB Hidradenitis Professor & Founding Chair│Department of Dermatology Suppurativa: Zucker School of Medicine at Hofstra/Northwell A N eed for N ew Therapeutic Professor│Center for Health Innovations & Outcomes Research Approaches Feinstein Ins
Slide 9: Disclosures
Disclosures Dr. Garg is an advisor for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, UCB, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences, and receives hono
Slide 10: HS has a high burden for patients with significant impact on quality of life
HS has a high burden for patients with significant impact on quality of life Prevalence1 Comorbidities*3,4 varies ~1% in most studied countries Proprietary and Confidential Property of UCB Obesity Diabetes Axial Spondyloarthritis Depression (axSpA) Others: Generalised Anxiety Disorder, Substance Dis
Slide 11: The patient HS journey is challenging
The patient HS journey is challenging Delays in diagnosis Suboptimal management The Global VOICE survey1 (N=1,229) In the Global VOICE survey1 In an online survey2 (N=128) with HS Proprietary and Confidential Property of UCB reported a 10-year delay in diagnosis (N=1,229) 45.9% of participants patie
Slide 12: Delayed diagnosis can lead to disease progression
Delayed diagnosis can lead to disease progression • Impairment to quality of life is greater in HS vs other dermatological conditions1–3 Proprietary and Confidential Property of UCB • Pain, shame, and embarrassment are closely linked with the severity of symptoms and greatly impact mental health, su
Slide 13: Delayed access to biologic treatment can further risk disease progression
Delayed access to biologic treatment can further risk disease progression In moderate to severe disease biologic therapy is an important treatment option1 Proprietary and Confidential Property of UCB In a US study of In a study of 225 patients 4 different 17 different 25,966 patients with HS in the
Slide 14: A window of opportunity may exist to support earlier treatment
A window of opportunity may exist to support earlier treatment To improve the quality of life of patients with moderate to severe HS a window of opportunity may exist to support earlier biologic treatment Functional Proprietary and Confidential Property of UCB Surgery impairment Window of opportunit
Slide 15: Summary
Summary 1 HS is a disabling disease with great psychological and functional impact on patients’ lives1 Proprietary and Confidential Property of UCB 2 Substantial delays in diagnosis and effective treatment can risk disease progression2,3 3 A window of opportunity may exist to support earlier treatme
Slide 16: Data from the Bimekizumab Phase 3 Studies in Hidradenitis Suppurativa
Data from the Proprietary and Confidential Property of UCB Bimekizumab Phase 3 Alexa Kimball, M.D. Studies in Hidradenitis Suppurativa Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, U.S (BE HEARD I and BE HEARD II) Bimekizumab is not approved for use in HS by any regula
Slide 17: Bimekizumab in moderate-to-severe HS: 48-week efficacy and safety from BE HEARD I & II
Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo-controlled, multicenter studies Proprietary and Confidential Property of UCB Alexa B. Kimball,1 Christos C. Zouboulis,2,3 Christo
Slide 18: Disclosures and Acknowledgements
Disclosures • ABK: Consultant and investigator for AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma; investigator for Incyte and AnaptysBio; consultant for Bayer, Boehringer Ingleheim, Ventyx, Moonlake, Concert, EvoImmune, Sonoma Bio, Sanofi, and receives fellowship
Slide 19: Background and BE HEARD I and II Study Design
Background and BE HEARD I and II Study Design Patients • Included: patients with a diagnosis of moderate to severe HS with ≥5 inflammatory lesions (abscess and inflammatory nodule [AN] count) • Excluded: patients with >20 draining tunnels Study Design Screening Double-Blind Initial Treatment Period
Slide 20: Patient Demographics and Characteristics at Baseline Generally Balanced Across Studies
Patient Demographics and Characteristics at Baseline were Generally Balanced Across Studies BE HEARD I BE HEARD II All Patients All Patients N=505 N=509 Age, years, mean (SD) 36.7 (12.0) 36.6 (12.4) Sex, female, n (%) 318 (63.0) 258 (50.7) Racial group, white, n (%) 393 (77.8) 415 (81.5) BMI, kg/m2,
Slide 21: Clinically Meaningful Improvements over Placebo at Week 16 in Primary Endpoint HiSCR50
Patients treated with Bimekizumab Achieved Clinically Meaningful Improvements over Placebo at Week 16 as Measured by the Primary Endpoint, HiSCR50 (mNRI [All-ABX]a) BE HEARD I met the primary endpoint of HiSCR50 for BKZ 320 mg Q2W versus placebo BE HEARD II met the primary endpoint of HiSCR50 for bo
Slide 22: HiSCR50 Responses Showed Sustained Improvements over Weeks
HiSCR50 Responses Showed Sustained Improvements over 48 Weeks HiSCR50 was sustained over time across BKZ groups in BE HEARD I and II, and patients switching from placebo to bimekizumab had a rapid increase in response within the first four weeks across both studies BE HEARD I mNRI (HS-ABX)a Observed
Slide 23: Deep Levels of Clinical Response at Week 16 Measured by HiSCR75
Bimekizumab Demonstrated Deep Levels of Clinical Response over Placebo at Week 16, as Measured by HiSCR75, a Key Secondary Endpoint (mNRI [All-ABX]a) BE HEARD I met the secondary endpoint of HiSCR75 for BKZ 320 mg Q2W versus placebo BE HEARD II met the secondary endpoint of HiSCR75 for both BKZ dose
Slide 24: HiSCR75 Responses Showed Sustained Improvements over Weeks
HiSCR75 Responses Showed Sustained Improvements over 48 Weeks HiSCR75 was sustained over time across BKZ groups in BE HEARD I and II, and patients switching from placebo to bimekizumab had a rapid increase in response within the first four weeks across both studies BE HEARD I mNRI (HS-ABX)a Observed
Slide 25: Improved Health-Related Quality of Life Compared with Placebo at Week 16
Patients Treated with Bimekizumab Experienced Improved Health-Related Quality of Life Compared with Placebo at Week 16 (MI [All-ABX]a) An improvement in DLQI Total Score was observed for BKZ 320 mg Q2W versus placebo in BE HEARD I Improvement in DLQI was also observed for both BKZ dose regimens vers
Slide 26: Overview of TEAEs: Weeks 0–16
Overview of TEAEs: Weeks 0–16 BE HEARD I BE HEARD II Placebo BKZ BKZ BKZ Placebo BKZ BKZ BKZ 320 mg Q4W 320 mg Q2Wa Totalb 320 mg Q4W 320 mg Q2Wa Totalb n (%) n=72 n=143 n=286 n=429 n=74 n=142 n=290 n=432 100 PY=0.22 100 PY=0.43 100 PY=0.87 100 PY=1.30 100 PY=0.23 100 PY=0.44 100 PY=0.88 100 PY =1.3
Slide 27: Safety Topics of Interest: Weeks 0–48
Safety Topics of Interest: Weeks 0–48 BE HEARD I BE HEARD II Placebo/BKZ BKZ 320 mg BKZ 320 mg BKZ 320 mg Placebo/BKZ BKZ 320 mg BKZ 320 mg BKZ 320 mg 320 mg Q2Wa Q4W/Q4W Q2W/Q4W Q2W/Q2W 320 mg Q2Wa Q4W/Q4W Q2W/Q4W Q2W/Q2W n (%) (n=65) (n=143) (n=145) (n=141) (n=69) (n=142) (n=146) (n=144) 100 PY=0.
Slide 28: BE HEARD I & II Conclusions
BE HEARD I & II Conclusions In patients with moderate to severe HS, bimekizumab achieved at Week 16: - The primary endpoint HiSCR50, providing greater improvements in HS clinical response versus placebo - A key secondary endpoint HiSCR75, a more stringent outcome, versus placebo - Clinically meaning
Slide 29: Conclusions
Proprietary and Confidential Property of UCB Conclusions Emmanuel Caeymaex Executive Vice President, Immunology Solutions and Head of US, UCB Bimekizumab is not approved for use in HS by any regulatory authority worldwide. The safety and efficacy of bimekizumab GL-N-BK-HS-2300006 29 in HS has not be
Slide 30: Q&A
Emmanuel Caeymaex Executive Vice President, Immunology Solutions and Head of US, UCB Proprietary and Confidential Property of UCB Q&A Amit Garg, M.D. Professor & Founding Chair│Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell, US Alexa Kimball, M.D. Beth Israel Deaconess Med
Slide 31: Thank you
Proprietary and Confidential Property of UCB Thank you Bimekizumab is not approved for use in HS by any regulatory authority worldwide. The safety and efficacy of bimekizumab GL-N-BK-HS-2300006 31 in HS has not been established. Bimekizumab is not approved for any indication by the U.S. Food and Dru
Slide 32: Proprietary and Confidential Property of UCB
Proprietary and Confidential Property of UCB