Slide 1: Impact of sonelokimab on clinical and imaging outcomes in axial spondyloarthritis
Impact of sonelokimab, a novel IL-17A/F-inhibiting Nanobody, on clinical and imaging outcomes in axial spondyloarthritis: First results of a Phase 2 study supported by 18F-NaF PET imaging and MRI Brikena Lalazi,1,2 Uta Kiltz,1,2 Philipp Sewerin,1,2 Hubertus Hautzel,3 Andreas Ramming,4 Roman Akbar-Ha
Slide 2: Disclosures
Disclosures BL reports no conflicts of interest. UK has been paid as a speaker for AbbVie, Eli Lilly, Fresenius, Novartis, and UCB; has worked as a paid consultant for AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB;
Slide 3: Axial spondyloarthritis (axSpA): Inflammation and new bone formation
Axial spondyloarthritis (axSpA): Inflammation and new bone formation • Dual blockade of IL-17A and IL-17F—two key inflammatory mediators—has been shown to be effective in axSpA1 • Control of inflammation is critical in axSpA due to potential new bone formation leading to structural damage and impair
Slide 4: Sonelokimab is a novel IL-17A- and IL-17F-inhibiting Nanobody
Sonelokimab is a novel IL-17A- and IL-17F-inhibiting Nanobody1–3 Anti-IL-17F Inhibits IL-17A and IL-17F Anti- albumin Conventional mAb Heavy-chain-only Nanobody (typical biologic) antibody (camelids) building block Extends half-life* Anti-IL-17A • Small • No Fc domain or IL-17F • Humanized A positiv
Slide 5: S-OLARIS: An innovative phase 2 open label study in active axSpA
S-OLARIS: An innovative phase 2 open label study in active axSpA Key eligibility criteria ≥18 years of age Clinical endpoints included: PET/MRI (18F-NaF) PET/MRI (18F-NaF) • ASAS20 and ASAS40 Diagnosis of axSpA and fulfilling • ASDAS improvement the 2009 ASAS N=~25 classification Sonelokimab 60 mg Q
Slide 6: Baseline characteristics
Baseline characteristics Patient characteristics Sonelokimab 60 mg (N=26) Age, years 30.7 (9.5) Male, n (%) 22 (85) BMI, kg/m2 27.0 (4.6) r-axSpA, n (%)/nr-axSpA, n (%) 17 (65)/9 (35) HLA-B27 positive, n (%) 19 (73) Time since axSpA symptom onset, years 8.1 (8.0) Prior bDMARD use, n (%) 2 (7.7) Conc
Slide 7: Sonelokimab treatment resulted in early ASAS responses
Sonelokimab treatment resulted in early ASAS responses Proportion of patients achieving ASAS response per visit (ITT-mNRI†) 100 • >80% of patients 89 88 92% ASAS20 achieved ASAS40 Patients achieving response by visit (%) 87 80 81% ASAS40 77 and ASAS20 in this 60 open-label study 54% ASAS PR 40 • Mor
Slide 8: Treatment with sonelokimab resulted in rapid ASDAS improvements
Treatment with sonelokimab resulted in rapid ASDAS improvements ASDAS score over time Percentage of patients with 4 (ITT-mNRI†) ASDAS improvement at Week 12 (ITT-mNRI†) 3.5 3 Major 58% Mean ASDAS score by visit improvement 2 1.6 Clinically important 1.4 89% improvement *** 1 1.2 *** *** 0 0 4 8 12 V
Slide 9: Most patients achieved inactive/low disease activity as early as Week 4
Most patients achieved inactive/low disease activity as early as Week 4 Percentage of patients in each ASDAS disease activity state over time (as observed) 100% 100 4 4 4 Patients achieving ASDAS disease state (%) 15 15 Very high disease 80 80% 46 35 activity (>3.5) 35 39 High disease activity 60% 6
Slide 10: Patient-reported symptoms and function significantly improved
Patient-reported symptoms and function significantly improved BASDAI score over time (ITT-mNRI†) 10 Change from baseline at Week 12 (ITT-mNRI) 8 Mean BASDAI score by visit Total BASDAI –4.7 (P<0.001) Back pain (Q2) –5.8 (P<0.001) 6 Fatigue (Q1) –5.1 (P<0.001) Morning stiffness –5.5 (P<0.001) (mean Q
Slide 11: Patient-reported symptoms and function significantly improved
Patient-reported symptoms and function significantly improved BASDAI score over time BASFI score over time (ITT-mNRI†) (ITT-mNRI†) 10 6 Change from baseline at Week 12 (ITT-mNRI) Change from baseline at Week 12 (ITT-mNRI) 8 Mean BASFI score by visit BASFI –3.3 (P<0.001) Mean BASDAI score by visit To
Slide 12: By Week 12, sonelokimab significantly reduced inflammatory lesion burden
By Week 12, sonelokimab significantly reduced inflammatory lesion burden SPARCC MRI score in the SIJ and spine (n=25; as observed†) 30 –21.8; P<0.001 24.8 Mean SPARCC MRI score at Week 12 25 20 15 –3.9; P=0.03 10 4.6 5 3.0 0.7 0 SIJ Spine Baseline Week 12 †Data analyzed for all 25 patients with base
Slide 13: Sonelokimab significantly reduced 18F-NaF uptake in the SIJ over 12 weeks
Sonelokimab significantly reduced 18F-NaF uptake in the SIJ over 12 weeks Participant-level adjusted mean 18F-NaF SUVmax Example 18F-NaF PET/MRI scan images (n=24; as observed†) Baseline 10 –2.9 P<0.001 8 6.7 44% 6 Mean SUVmax Week 12 4 3.8 Reduction in background- corrected SIJ 18F-NaF PET SUV 2 ma
Slide 14: 18F-NaF PET+ and MRI lesion burden was reduced across SIJ quadrants
18F-NaF PET+ and MRI lesion burden was reduced across SIJ quadrants Number (and percentage) of all evaluated SIJ quadrants with 116 18F-NaF PET positivity and MRI lesions (n=24) 120 (60%) 104 103 (54%) (54%) Number of SIJ quadrants with finding 100 89 (46%) 80 (42%) 80 Reduction in 18F-NaF PET-posit
Slide 15: Sonelokimab was well tolerated, with no new safety signals
Sonelokimab was well tolerated, with no new safety signals Sonelokimab 60 mg Patients with events, n (%) N=26 Any TEAE 14 (53.8) Any treatment-related TEAE 4 (15.4) Any serious TEAE 1 (3.8) Any TEAE leading to treatment discontinuation 1 (3.8) Most frequent TEAEs • All adverse events were Influenza
Slide 16: Conclusions
Conclusions • Sonelokimab treatment resulted in rapid achievement of clinical responses in this Phase 2 open-label study in axSpA • Substantial reductions in objective imaging-based assessments of inflammation and pathological osteoblastic activity were observed in the SIJ after only 12 weeks • The
Slide 17: Acknowledgments
Acknowledgments • The authors and MoonLake Immunotherapeutics AG would like to thank all patients who participated in the trial, their families, and the staff at each site who assisted with the trial • We would also like to acknowledge Alex Godwood and James Roberts (MoonLake Immunotherapeutics AG)