Viatris Inc. · NASDAQ:VTRS
Viatris — APLAR 2024
15 slides from Viatris's conference presentation, August 2024
Slide 1: Cenerimod - SLE APLAR Presentation August 2024
DRAFT Cenerimod - SLE APLAR Presentation August 2024 For internal use, education and training purposes only. Do not duplicate, distribute or use when detailing. This document contains confidential and proprietary This document contains proprietary information of Viatris Inc. Unauthorized use, duplic
Slide 2: Cenerimod in Japanese patients with moderate to severe SLE: A Phase 2 trial
Cenerimod in Japanese patients with moderate to severe SLE: A Phase 2, randomized, double-blind, parallel-group, multicenter trial 1Ouali Berkani, 2Peter Cornelisse, 1Gustavo Seifer 1Viatris, Allschwil, Switzerland 2Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland Presenter: Sharavan Kanagaratna
Slide 3: Background
Background Cenerimod Novel MoA acting on the three main pillars of SLE pathogenesis Cenerimod is a potent, oral, selective Sphingosine-1- S1P1 receptor modulation can Overall, cenerimod’s phosphate 1 (S1P1) receptor Inhibit the egress of autoreactive T- and immunomodulatory properties modulator. B-c
Slide 4: Phase 2a efficacy and safety data
Background Phase 2a efficacy and safety data AC-064A201, 67 patients* (placebo, 0.5, 1, 2, and 4 mg) Well tolerated at all doses tested with no associated clinically relevant safety finding. mSLEDAI-2K change from baseline 7.5 Mean mSLEDAI-2K score ±SE 5.0 Placebo 0.5 mg 2.5 1 mg 2 mg 4 mg Baseline
Slide 5: Phase 2b efficacy and safety data
Background Phase 2b efficacy and safety data ID-064A202 (CARE study*), 427 patients (placebo, 0.5, 1, 2, and 4 mg) Clinically meaningful reduction in disease activity was seen with 4 mg dose at 6 months. Well tolerated over a treatment period of 6 months. mSLEDAI-2K LSM change between cenerimod 4 mg
Slide 6: Consistent safety and efficacy data from both Phase 2 studies with cenerimod
Consistent safety and efficacy data were reported from both Phase 2 studies with cenerimod 4 mg showing maximum efficacy and all the tested doses (0.5, 1, 2, and 4 mg) were safe and well tolerated. The current study (ID-064A203) evaluated the safety, pharmacodynamics, and efficacy of cenerimod (2 mg
Slide 7: Methodology
Methodology Randomized, double-blind, parallel-group, multicenter, phase 2 study. Major Inclusion criteria • mSLEDAI-2K score of ≥ 6 points, including ≥ 2 for musculoskeletal or mucocutaneous manifestations • History of positive ANA or dsDNA • Stable on SLE background therapy EOT, end of treatment (
Slide 8: Study Objectives
Study Objectives Primary objective: Safety and tolerability Primary Endpoint: TEAEs that occurred until EOS. Secondary objectives: Pharmacodynamics and Efficacy Secondary Endpoints: • Changes in total lymphocyte count from baseline to each post-baseline assessment up to EOS. • Change in mSLEDAI-2K s
Slide 9: Results: Patient Disposition
Results Patient Disposition Screened (N=21) Screen Failure (N=4) Randomized (N=17) 2 mg group: 9 patients; 4 mg group: 8 patients Treatment discontinued (N=1)* Treatment completed (N=16) 2mg group: 9 patients; 4 mg group: 7 patients *One subject in the cenerimod 4 mg group prematurely discontinued t
Slide 10: Demographic and baseline characteristics
Demographic and baseline characteristics Variable Cenerimod 2 mg Cenerimod 4 mg Total Statistics or category N=9 N=8 N=17 Sex [n(%)] Female 7 (77.8) 8 (100) 15 (88.2) Male 2 (22.2) 0 2 (11.8) Age (years) Mean ± SD 42 ± 13.90 40.4 ± 10.04 41.2 ± 11.89 Minimum, Maximum 19, 61 30, 56 19, 61 Race [n(%)]
Slide 11: Safety analysis
Safety analysis Summary of overall safety events Adverse events in ≥ 2 patients Cenerimod 2 mg Cenerimod 4 mg Cenerimod 4 mg Cenerimod 2 mg (n=9); n (%) (n=8); n (%) (n=9); n (%) (n=8); n (%) Patients with at least one TEAE 8 (88.9%) 6 (75%) Patients with at least one SAE* 1 (11.1%) 2 (25%) Hepatic
Slide 12: Pharmacodynamic analysis
Pharmacodynamic analysis 2.0 Cenerimod 2 mg Cenerimod 4 mg 0.5 Cenerimod 2 mg Cenerimod 4 mg Mean (±SD) change from baseline in Mean (±SD) total lymphocyte count total lymphocyte count till EOS 1.5 0.0 from baseline to EOS 1.0 -0.5 0.5 -1.0 0.0 -1.5 Baseline Week 4 Week 8 Week 12 Week 16 Week 28 Wee
Slide 13: Efficacy analysis Study 203
Efficacy analysis Study 203: Change (mean ± SE) in mSLEDAI- 2K from Baseline to EOT and EOS N=9 N=7 N=9 N=8 0 • The change (mean ± SE) in mSLEDAI-2K total Change (mean ± SE) in mSLEDAI-2K score from baseline to EOT was −1.3 ± 1.0 and −2.4 ± 1.02 in the 2 mg and 4 mg groups, respectively. The change
Slide 14: Efficacy analysis (in comparison to CARE Study)
Efficacy analysis (in comparison to CARE Study) • Higher number of Asian patients with SLE are known to have IFN-1 high gene expression. • Comparable efficacy results between this study and CARE study (IFN-1 high subgroup) were observed. Study 203: Change (mean ± SE) in Study 202: Change (mean ± SE)
Slide 15: Conclusion
Conclusion • Both cenerimod doses were considered safe and well-tolerated. • As expected, a decrease in lymphocyte counts was observed in both doses and was reversible upon treatment discontinuation. • Both doses showed an improvement in disease activity, as measured by mSLEDAI-2K, which persisted l