Ipsen Sa · EURONEXT:IPN
Ipsen Sa — AASLD 2023 Investor Science Conference Call
28 slides from Ipsen Sa's conference presentation, October 2023
Slide 1: Investor science conference call AASLD 2023
Raphael Research Assistant, R&D Les Ulis, France Investor science conference call AASLD 2023 Focus. Together. For patients & society 1
Slide 2: Disclaimer and safe harbor
Disclaimer and safe harbor − This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and estimates contained herein are for illustrative purposes only and are based on management’s current views and assumptions. Such statement
Slide 3: Speakers
Speakers Jennifer Schranz Dr. Christopher L. Bowlus David ForLoew Q&A SVP, Global Head Rare Disease Lena Valente Professor and Howard Chief Executive Mayer Officer Research & Development Chief of the Division of Head of Research & Gastroenterology and Hepatology at Development the University of Cali
Slide 4: Jennifer Schranz
Jennifer Schranz SVP, Global Head Rare Diseases Research & Development 4
Slide 5: Bringing transformative first-in-class, best-in-class medicines to patients
Bringing transformative first-in-class, best-in-class medicines to patients Oncology Rare Disease Neuroscience Strengthening Expanding Excelling and accelerating the position the scope Recent external innovation Transactions across rare cholestatic liver disease Five potential rare cholestatic disea
Slide 6: Ipsen at AASLD 2023
Ipsen at AASLD 2023 Growing presence in rare cholestatic liver disease Demonstrating strength & expertise in understanding pathophysiology of rare cholestatic liver diseases Eleven abstracts accepted for presentation Two late-breakers Furthering scientific understanding across several underserved ra
Slide 7: Dr. Christopher L. Bowlus
Dr. Christopher L. Bowlus Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis 7
Slide 8: Efficacy and safety of elafibranor in primary biliary cholangitis: ELATIVE phase 3 trial
Efficacy and safety of elafibranor in primary ™ biliary cholangitis: Results from the ELATIVE double-blind, randomized, placebo-controlled phase 3 trial Christopher L. Bowlus,1 Kris V. Kowdley,2,3 Cynthia Levy,4 Ulus Akarca,5 Mario Reis Alvares-da-Silva,6 Pietro Andreone,7 Marco Arrese,8 Christophe
Slide 9: Background
Background Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 • Primary biliary cholangitis (PBC) is a rare, autoimmune, chronic cholestatic liver disease that occurs predominantly in women >40 Elafibranor years1–3 • Ursodeoxycholic acid (UDCA) and obeticholic acid (OCA) are the PPAR⍺ PPARδ on
Slide 10: ELATIVE phase 3 trial objectives and design
ELATIVE™ phase 3 trial objectives and design Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 ELATIVE™ aimed to evaluate the efficacy and safety of elafibranor in adult patients with PBC with an inadequate response or intolerance to UDCA Screening and randomization Randomized-controlled tria
Slide 11: Study endpoints and assessments
Study endpoints and assessments Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 1. Proportion of patients with biochemical response at Week 52, defined as ALP Primary endpoint <1.67x ULN, with a reduction of ≥15% from baseline, and total bilirubin levels at or below ULN 1. Proportion of pat
Slide 12: Baseline demographics and disease characteristics were well balanced between the groups
Baseline demographics and disease characteristics were well balanced between the groups Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Characteristic Elafibranor (n=108) Placebo (n=53) Age at randomization, years, mean (SD) 57.5 (8.4) 56.4 (9.3) Sex, female, n (%) 102 (94.4) 52 (98.1) Race
Slide 13: Significant improvement in biochemical response at Week 52
Treatment with elafibranor led to a significant improvement in biochemical response at Week 52 Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 70 Patients with a biochemical response (%) p<0.0001 60 51 50 40 Treatment benefit: 47% 30 95% CI: 32% to 57% 20 10 4 0 Elafibranor 80mgmg Elafibran
Slide 14: Only elafibranor patients achieved normalization of ALP at Week 52
Only patients receiving elafibranor achieved normalization of ALP at Week 52 Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 20 p=0.0019 Patients with normalization of ALP (%) 15 15 10 Treatment benefit: 15% 95% CI: 6% to 23% 5 0 0 Elafibranor 80mgmg Elafibranor 80 Placebo Placebo (N=108) (
Slide 15: Reductions in ALP observed early and sustained through Week 52
Reductions in ALP were observed as early as Week 4 and sustained through Week 52 Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Elafibranor 80 mg Placebo 1% 2% Percentage change in ALP from baseline 0% –1% –3% over time (mean ± SEM) Treatment difference: –41% 95% CI: –48% to –33% p<0.0001a
Slide 16: Pruritus scales used in ELATIVE
Pruritus scales used in ELATIVE Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Unidimensional scale that quantitatively measures the intensity of itch PBC • 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) Worst-Itch • Assessed daily NRS1 • Recall period of 24 hours Mu
Slide 17: Change in PBC Worst Itch NRS score through Week 52
A trend for improvement was observed in PBC Worst Itch NRS score, but did not reach statistical significance through Week 52 Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Change in PBC Worst Itch NRS by each 4-week period Change through Week 52 Elafibranor 80 mg Placebo Elafibranor 80mgmg
Slide 18: Elafibranor improved pruritus based on PBC-40 Itch score
Treatment with elafibranor improved pruritus based on the PBC-40 Itch score Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Change in PBC-40 Itch score from baseline Change at Week 52 Elafibranor 80 mg Placebo Change in PBC- 40 Itch total score from baseline Elafibranor Elafibranor 80 mg Pl
Slide 19: Greater reductions in 5-D Itch total score
Greater reductions in 5-D Itch total score were also observed Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Change in 5-D Itch total score from baseline Change at Week 52 Elafibranor 80 mg Placebo Elafibranor Elafibranor 80 mg Placebo (n=42) (N=42) (n=16) (N=16) Change in 5-D Itch total s
Slide 20: Elafibranor was generally well tolerated
Elafibranor was generally well tolerated Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Safety analyses were inclusive of all data up to Week 104 Elafibranor Placebo Event, n (%) (n=108) (n=53) Any TEAE 104 (96.3) 48 (90.6) Abdominal paina 12 (11.1) 3 (5.7) Diarrhea 12 (11.1) 5 (9.4) Nause
Slide 21: Summary
Summary Presented by Dr Christopher L. Bowlus #48490, AASLD 2023 Treatment with elafibranor led to a significant improvement in biochemical response compared with placebo at Week 52 (51% vs 4%; treatment benefit 47%) • Reductions in ALP were rapid and sustained through Week 52 • Only patients treate
Slide 22: David Loew
David Loew Chief Executive Officer 22
Slide 23: Elafibranor: central to expanding scope in Rare Disease
Elafibranor: central to expanding scope in Rare Disease Rare cholestatic liver diseases FOP Elafibranor Launched in U.S. Compelling data: Regulatory approval PFIC + ALGS Phase III ELATIVE trial in U.S. Launched in E.U. U.S. & E.U. A breakthrough for PFIC regulatory submissions FOP community anticipa
Slide 24: Conclusion
Conclusion Elafibranor Compelling Phase III results A transformative potential treatment option for patients Significant unmet medical need Focus. Together. For patients & Central to expanding Ipsen’s society scope in Rare Disease 24
Slide 25: Questions
QUESTIONS ‘provaten for patent ere
Slide 26: Thank you
THANK YOU 26
Slide 27: Investor Relations
Investor Relations Adrien DUPIN DE SAINT-CYR Adrien DUPIN DE SAINT-CYR CraigRelations Investor MARKS Manager Nicolas BOGLER Investor Relations Manager Vice President, Investor Relations Investor Relations Senior Manager +44 7564 349 193 +33 6 52 19 98 92 craig.marks@ipsen.com nicolas.bogler@ipsen.co
Slide 28: Follow us
Follow us www.ipsen.com 28