By VETTAPHARMA reporter – Derek Roche: MoonLake Immunotherapeutics (NASDAQ: MLTX) announced positive topline results from its Phase 2 S-OLARIS clinical trial evaluating sonelokimab (SLK) in patients with radiographic and non-radiographic axial spondyloarthritis (axSpA). In the Phase 2 S-OLARIS trial, 81% of patients treated with SLK (n=26, mNRI) achieved an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 12, which was both statistically significant and clinically meaningful. ASAS40 measures at least a 40% improvement and an absolute improvement of ≥2 units on a 0–10 numerical rating scale in at least three of four key domains — Patient Global Assessment of disease activity, total back pain, physical function, and inflammation — with no worsening in the remaining domain.
More than 80% of patients also achieved a clinically important improvement as per ASDAS-CRP score by Week 12 (mNRI). Clinical improvement was further confirmed by SPARCC MRI scores in the sacroiliac joints, measuring inflammation and injury inside the bone
Importantly, PET imaging using an 18F-NaF tracer demonstrated a significant reduction in inflammation and osteoblast activity in sacroiliac joints affected by axSpA by Week 12. Osteoblast activity is a key driver of irreversible ossification in the disease, suggesting potential for disease modification with SLK
As a biomarker-controlled trial, S-OLARIS data showed SLK reduced levels of key inflammatory mediators in axSpA in peripheral blood and biopsy samples. The safety profile of SLK in the S-OLARIS trial was consistent with previous trials, with no new safety signals detected
The S-OLARIS trial (M1095-axSpA-201) recruited 26 patients, with the primary endpoint evaluating change from baseline in 18F-NaF SUVmax signals at Week 12 in the sacroiliac joints and spine.
Axial spondyloarthritis typically affects individuals under 45 years of age and has a reported global prevalence ranging from 0.5% to 1.5%
