MoonLake Immunotherapeutics (MLTX), on Sunday, announced positive results from its phase 2 trial of Investigational drug Sonelokimab in patients with radiographic and non-radiographic axial spondyloarthritis, sending shares up over 10% to $20 in overnight trading.
Axial spondyloarthritis, or axSpA, is a disease driven by inflammation, leading to irreversible ossification through osteoblast activity and ultimately to irreversible restriction of mobility. Several drugs are currently approved for axSpA, including TNF inhibitors (which block tumor necrosis factor alpha), IL-17 inhibitors (which block interleukin 17), and JAK inhibitors (which target Janus kinase pathways).
Sonelokimab, also known as SLK, works by targeting sites of inflammation by inhibiting the IL-17A/A, IL-17A/F, and IL-17F/F dimers. These interleukins are involved in causing inflammation in various autoimmune conditions. By blocking these proteins, Sonelokimab may help reduce inflammation and improve symptoms in patients with psoriasis, psoriatic arthritis, and hidradenitis suppurativa. (Source: ClinicalTrials.eu)
In the phase 2 trial, dubbed S-OLARIS, Sonelokimab demonstrated a clinically meaningful and statistically significant benefit, according to the company.
At Week 12, 81% of patients treated with Sonelokimab achieved an Assessment of Spondyloarthritis International Society 40 (ASAS40) response. ASAS40 indicates at least a 40% improvement and an absolute improvement of 2 or more points on a 0 to 10 scale in at least three of four key areas, namely Patient Global Assessment of disease activity, total back pain, physical function, and inflammation. ASAS40 has been the primary endpoint for the latest approved therapies.
More than 80% of patients in the study also achieved a clinically meaningful improvement by Week 12, as measured by the ASDAS-CRP score, which assesses overall disease activity, and by SPARCC MRI scores, which evaluate visible inflammation in the sacroiliac joints.
PET imaging showed a significant reduction of inflammation and osteoblast activity in sacroiliac joints affected by axSpA, a key driver of irreversible ossification in the disease. The safety profile of SLK in the S-OLARIS trial was consistent with previous trials, with no new safety signals detected, the company added.
Commenting on the study results, Prof. Xenofon Baraliakos, Head of Rheumatology at the Rheumazentrum Ruhrgebiet Herne & President of the European Alliance of Associations for Rheumatology (EULAR), said, "Completing the S-OLARIS trial has been a remarkable milestone for the axSpA and broader Rheumatology community. The combination of clinical, imaging, and biomarker data presents one of the clearest demonstrations to date of how targeting IL-17A and IL-17F with a Nanobody can meaningfully reduce inflammation in the axial structures".
Sonelokimab is also being explored in the following trials:
-- A phase 3 trial of Sonelokimab in adult participants with moderate to severe hidradenitis suppurativa, dubbed VELA-1, and another identical phase III trial of Sonelokimab in adult participants with moderate to severe hidradenitis suppurativa, dubbed VELA-2.-- A phase 3 clinical trial of Sonelokimab in adolescent patients with moderate-to-severe hidradenitis suppurativa, dubbed VELA-TEEN.-- A phase 3 study of Sonelokimab in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy, dubbed IZAR-1.-- A phase 3 study of Sonelokimab in adults with active psoriatic arthritis who have had a previous inadequate response or intolerance to anti-tumour necrosis factor (TNF) alpha therapy, dubbed IZAR-2. This study includes AbbVie's Skyrizi as an active reference arm.
Near-term Catalysts
-- 52-week data of the VELA-1 and VELA-2 trials are expected in Q2, 2026.-- Primary endpoint readout of the phase 3 IZAR-1 trial is due in mid-2026.-- Primary endpoint readout of the phase 3 VELA-TEEN trial is scheduled for mid-2026.-- Primary endpoint readout of the phase 3 IZAR-2 trial is due in the second half of 2026.-- Submission of a BLA for Sonelokimab in the indication of hidradenitis suppurativa is planned for the second half of 2026.
Cash Position
MoonLake ended Dec.30, 2025, with $394 million in cash, cash equivalents and short-term marketable debt securities. Together with the $75 million raised in its latest equity financing, the company expects this funding to provide a cash runway into the second half of 2027.
When we alerted readers to MLTX on Jan.9, 2026, it was trading at $15.17. The stock closed Friday's (Feb.20, 2026) trading at $18.77, up 3.30%.
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