MoonLake Immunotherapeutics has reported positive topline results from the phase 3 IZAR-1 trial evaluating its lead nanobody candidate, sonelokimab, in adults with active psoriatic arthritis who had not previously received biologic treatments.
The Switzerland-based biotechnology company said the study met all primary and secondary clinical endpoints at week 16. Sonelokimab is being studied as a treatment for inflammatory diseases including psoriatic arthritis and hidradenitis suppurativa.
Week 16 Results Met Primary and Secondary Endpoints
According to MoonLake, 42.1% of patients receiving a 60 mg dose of sonelokimab following an initial induction dose achieved an American College of Rheumatology 50 (ACR50) response at week 16.
The company also reported that 66.5% of patients achieved an ACR20 response. In addition, 41.2% of participants reached minimal disease activity (MDA).
Among patients who had both psoriatic arthritis and skin-related psoriasis symptoms, 61% achieved a Psoriasis Area and Severity Index 90 (PASI90) response by week 16.
MoonLake further stated that patients experienced improvements in physical function and quality of life measures during the study period. No new safety concerns were identified.
Trial Continues as Treatment Comparisons Remain Blinded
The IZAR-1 study is one of two global randomized, double-blind phase 3 trials assessing subcutaneously administered sonelokimab in adults with active psoriatic arthritis.
Participants enrolled in IZAR-1 had not previously received biologic therapies. The trial uses a placebo control arm, but MoonLake has not yet disclosed comparative efficacy results between treatment groups. The company said treatment-arm data and placebo comparisons will remain blinded until completion of the broader phase 3 program.
“The positive topline results from IZAR-1 represent an important milestone for MoonLake and, more importantly, for patients living with psoriatic arthritis. We are particularly encouraged by the strong efficacy observed across multiple clinically relevant endpoints simultaneously, which has been our focus,” said Jorge Santos de Silva, Ph.D., founder and chief executive officer of MoonLake.
The study will continue through 52 weeks, with full results expected during the first half of 2027.
Second Phase 3 Study Evaluates Additional Patient Population
The second phase 3 study, IZAR-2, is evaluating sonelokimab in patients whose symptoms have not improved after treatment with tumor necrosis factor (TNF) inhibitors, including Humira. Unlike IZAR-1, the IZAR-2 trial includes a direct comparison with AbbVie’s Skyrizi.
Sonelokimab is MoonLake’s lead drug candidate and was licensed from Germany’s Merck KGaA in 2021. The therapy is classified as a nanobody, a type of biologic distinct from currently approved therapies. The drug targets interleukin-17A and interleukin-17F and also binds to albumin.
Beyond psoriatic arthritis, sonelokimab is being evaluated in multiple phase 3 studies for hidradenitis suppurativa. The company has also reported positive phase 2 data for the drug in axial spondyloarthritis.
Following the announcement, MoonLake shares fell more than 8% in premarket trading. Reuters reported that the decline reflected investor concerns about how the data compared with UCB’s FDA-approved biologic Bimzelx. Clear Street analyst Kaveri Pohlman said the sonelokimab results were strong and largely matched results previously reported for Bimzelx, while also noting that the absence of disclosed placebo comparisons made it difficult to assess the magnitude of benefit relative to placebo.
MoonLake has reported positive Phase 3 results for sonelokimab in patients with active psoriatic arthritis. The results represent an important milestone for MoonLake as the company advances its lead therapeutic program toward potential regulatory submissions.
The findings add to growing evidence supporting sonelokimab as a potential treatment for patients whose symptoms remain difficult to control with existing therapies.
MoonLake Advances Sonelokimab Development
The latest data strengthen MoonLake’s position in the inflammatory disease market. Sonelokimab is an investigational Nanobody-based therapy designed to target interleukin-17A and interleukin-17F, two inflammatory proteins involved in several immune-mediated diseases.
For MoonLake, the Phase 3 results provide important clinical evidence as the company prepares for the next stages of development.
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