MoonLake S-OLARIS Phase 2 Topline: Sonelokimab ASAS40 81% at Week 12

MoonLake Immunotherapeutics reports topline Phase 2 results for sonelokimab (SLK) from the S-OLARIS Phase 2 trial in patients with radiographic and non-radiographic axial spondyloarthritis.

SLK-treated patients were reported to have an ASAS40 responder rate of 81% at Week 12. The report adds that the ASAS40 result was analyzed using mNRI (modified non-responder imputation) and reported in a treated cohort of 26 patients (n=26) for the cited responder endpoint. Alongside ASAS40, more than 80% of patients achieved a “clinically important improvement” as assessed by ASDAS-CRP at the same timepoint. Week 12 responder outcomes include ASAS40 and clinically important improvement by ASDAS-CRP.

The release also links symptomatic outcomes to imaging-based assessments in the sacroiliac joint. Clinical improvement in SLK-treated patients was supported by Week 12 SPARCC MRI sacroiliac joint (SIJ) scores, which it characterizes as measuring inflammation and injury inside the bone. It further reports that PET imaging using an 18F-NaF PET tracer collected in the trial showed reductions in inflammation and osteoblast activity in sacroiliac joints affected by axial spondyloarthritis. These imaging readouts are presented as objective signals aligned with the clinical responder endpoints described earlier.

Beyond imaging, the objective peripheral blood and tissue biomarker analyses showed rapid and sustained effects of SLK treatment in inhibiting key immune pathways described as driving inflammation and ossification in affected patients. For safety, the filing characterizes the safety profile in S-OLARIS as consistent with previous trials, with no new safety signals detected.

Key Takeaways:

• The company reports an ASAS40 responder rate of 81% at Week 12 in SLK-treated patients in the Phase 2 S-OLARIS trial.
• The report frames ASAS40 using mNRI and a reported treated cohort of n=26, and it also states that more than 80% achieved “clinically important improvement” by ASDAS-CRP at the same timepoint.
• The disclosure describes supportive objective readouts (SPARCC MRI in the sacroiliac joint; 18F-NaF PET reductions in inflammation and osteoblast activity; peripheral blood and tissue biomarker inhibition of immune pathways) alongside a safety characterization of no new signals.