Immunic, Inc. · NASDAQ:IMUX
Immunic — ECTRIMS 2022
16 slides from Immunic's conference presentation, Oct 27, 2022
Slide 1: Dose-dependency of efficacy variables and biomarkers for vidofludimus calcium in EMPhASIS
Assessment of dose-dependency of anti-inflammatory and neuroprotective efficacy variables and biomarkers for vidofludimus calcium in EMPhASIS: A randomized, placebo- controlled phase 2 trial in relapsing-remitting multiple sclerosis ECTRIMS 2022 | Amsterdam (26-28 October 2022) R.J. Fox1, H. Wiendl2
Slide 2: Disclosures
Disclosures • RJF: reports personal fees from AB Science, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Immunic AG, Janssen Novartis, Sanofi, and TG Therapeutics; clinical trial contracts from Biogen, Novartis, and Sanofi. • HW: reports grants and personal fees from AbbVie, Biogen, Merck Serono,
Slide 3: IMU-838 (Vidofludimus Calcium)
IMU-838 (Vidofludimus Calcium) Next-generation, small-molecular DHODH inhibitor for RRMS1 • Optimized for human DHODH inhibition • Lack of off-target effect on kinases • Safety profile obtained from exposure to 1100+ humans Convenient pharmacokinetic profile2 • Once daily oral application • Serum ha
Slide 4: EMPhASIS: Phase 2 Study Overview
EMPhASIS: Phase 2 Study Overview Included population: RRMS with relevant disease activity • Male or female ( 18 ≤ age ≤ 55) • RRMS diagnosis (Revised McDonald criteria 2017) • Evidence of disease activity based on relapse (1 relapse in last 12 months or 2 relapses in last 24 months) and MRI criteria
Slide 5: EMPhASIS: Phase 2 Trial Design in RRMS
EMPhASIS: Phase 2 Trial Design in RRMS Trial Flow Chart Screening up to 28 days Main treatment period 24 weeks Extended treatment period up to 9.5 years (optional) Blinded Unblinded 30 mg IMU-838 Cohort 1 R 45 mg IMU-838 30 mg IMU-838 30 mg IMU-838 R Screening. Baseline exam MRI Placebo 45 mg IMU-83
Slide 6: EMPhASIS: Phase 2 Trial Design in RRMS
EMPhASIS: Phase 2 Trial Design in RRMS Trial Flow Chart Screening up to 28 days Main treatment period 24 weeks Extended treatment period up to 9.5 years (optional) Blinded Unblinded 30 mg IMU-838 Cohort 1 R 45 mg IMU-838 30 mg IMU-838 30 mg IMU-838 R Screening. Baseline exam MRI Placebo 45 mg IMU-83
Slide 7: Vidofludimus Plasma Trough and Peak Levels
Vidofludimus Plasma Trough and Peak Levels (µg/mL) (up to Week 24) 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0,000 Day 0 Day 7 Week 6 Week 12 Week 18 Week 24 10mg IMU-838 30mg IMU-838 45mg IMU838 10mg (Post-Dose) 30mg (Post-Dose) 45mg (Post-Dose) Safety analysis set C1/C2 (N10 =47, N30 =71, N45 =
Slide 8: Relationship Between Trough Levels and Cumulative CUA Lesions at Week 24
Relationship Between Trough Levels of Vidofludimus and Number of Cumulative CUA Lesions at Week 24 Cumulative CUA Lesions and trough Levels (up to Week 24) 7 7 6.074 µg/mL 6 6 Treatment Adjusted Percentage 5.9 Group Mean Change 5 5 4 4 Placebo 5.8 (ref) 4.061 µg/mL 3 3 10 mg IMU-838 5.9 +2% 2 1.936
Slide 9: Relationship Between Trough Levels and Gd+ Lesions at Week 24
Relationship Between Trough Levels of Vidofludimus and Number of Gd+ Lesions at Week 24 Gd+ Lesions and Trough Levels (up to Week 24) 7 7 6.074 µg/mL 6 6 Treatment Adjusted Percentage Group Mean Change 5 5 4 4 Placebo 4.6 (ref) 4.0 4.061 µg/mL 3 3 10 mg IMU-838 4.0 -13% 2 1.936 µg/mL 2 30 mg IMU-838
Slide 10: Dose-dependent reduction of NfL
Dose-dependent reduction of NfL Median % Change of Serum Neurofilament from Baseline Compared to Placebo 10 5 0 -5 -9% -10 -15 -18% -20 -25 -26% -30 10 mg IMU-838 30 mg IMU-838 45 mg IMU-838 Displayed are median values of differences between percentage change of serum neurofilament light chain conce
Slide 11: No Safety signal (dose-dependent or otherwise)
No Safety signal (dose-dependent or otherwise) Serious Adverse Events Placebo 10 mg IMU-838 30 mg IMU-838 45 mg IMU-838 (SAEs) (N=81) (N=47) (N=71) (N=69) Number of patients 1 0 2 0 Number of events leading 1 0 2 0 to discontinuations Types of SAEs Squamous cell None Open fracture None carcinoma Ure
Slide 12: Conclusion
Conclusion Doses of 30 and 45 mg of vidofludimus calcium showed compelling anti-inflammatory effects (with 65 – 78% reduction in CUA and Gd+ lesions) and other signs of clinical activity A dose-dependent neuroprotective effect of vidofludimus calcium was shown on serum NfL in the 10 to 45 mg dose gr
Slide 13: Thank you.
Thank you.
Slide 14: Back-up slides
Back-up slides
Slide 15: EMPhASIS: Phase 2 Trial in RRMS - Patient Disposition
EMPhASIS: Phase 2 Trial in RRMS Patient Disposition in Main Period Screening up to 28 days Main treatment period 24 weeks Extended treatment period up to 9.5 years (optional) Blinded Unblinded Placebo (N=69) Discontinued (N=5) Completed Week 24 (N=64) Cohort 1 Patient Randomized (N=210) Not Treated
Slide 16: Discontinuations
Discontinuations Treatment Discontinuation before Week 24 (all dosed patients until end of blinded treatment) N (%) Placebo 10 mg IMU-838 30 mg IMU-838 45 mg IMU-838 (N=81) (N=47) (N=71) (N=69) 6 (7.4) 2 (4.3) 2 (2.8) 4 (5.8) Reason for discontinuation treatment • Liver enzyme elevations • Other rea