Reported Sunday, MoonLake Reports Phase 2 S-OLARIS Data Showing Sonelokimab Achieved 80%+ ASAS40 Response In Axial Spondyloarthritis With PET/MRI Imaging Confirming Deep Tissue Inflammation Reduction
MoonLake Immunotherapeutics Class A +5.08%
MoonLake Immunotherapeutics Class A MLTX | 17.36 | +5.08% |
- In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12
- Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients treated with SLK, including ASDAS-CRP and SPARCC MRI
- axSpA is a disease driven by inflammation leading to irreversible ossification (via osteoblast activity) and ultimately to irreversible restriction of mobility – objective PET/MRI imaging data further showed a significant reduction in inflammation and osteoblast activity deep in affected joints, already by week 12, suggesting potential for disease modification in axSpA for SLK
- As a biomarker-controlled trial, S-OLARIS data showed SLK reduced the levels of key inflammatory mediators in axSpA, in peripheral blood and biopsy samples from patients – the safety profile of SLK was similar to other trials and no new signals were detected
- MoonLake ended the fourth quarter with $394 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from its latest equity raise (gross proceeds of $75 million), are expected to provide a cash runway into the second half of 2027
- The Company also announced the amendment of its debt facility with Hercules Capital, with a concurrent drawdown of $25 million, and up to $400 million in non-dilutive funds remaining available to support future funding needs
- An Investor Day webcast has been confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session