MoonLake Immunotherapeutics (MLTX) announced positive topline results from its Phase 3 IZAR-1 trial evaluating Sonelokimab in biologic-naïve adults with active psoriatic arthritis.
Psoriatic arthritis (PsA) is a chronic, progressive inflammatory diseases that affects up to 30% of patients with psoriasis, typically between ages 30 and 60. It manifests across multiple domains, including joint inflammation, enthesitis, dactylitis, spinal involvement, and skin and nail disease. The condition can lead to significant disability and reduced quality of life, with IL-17 pathway activation recognized as a key driver of disease activity.
Sonelokimab is a Nanobody targeting IL-17A and IL-17F, designed to deliver high potency with small molecular size and albumin-binding properties that may enhance tissue penetration. It is being developed as a potential next-generation therapy across multiple inflammatory disease.
IZAR-1 Results
The Phase 3 IZAR-1 trial met its primary endpoint at Week 16, with 42.1% of patients receiving Sonelokimab 60 mg with induction achieving an ACR50 response. Strong efficacy was also observed across key secondary endpoints: 66.5% achieved ACR20, 41.2% reached Minimal Disease Activity (MDA), and 61% of patients with skin involvement achieved PASI90. Improvements were also seen in patient-reported outcomes, including a mean change of -0.427 in HAQ-DI and a 6.54-point increase in SF-36 PCS, underscoring benefits in physical function and quality of life.
Safety findings were consistent with prior studies, with no new signals identified and a low drop-out rate, reinforcing Sonelokimab's potential as a treatment option for PsA.
About the IZAR Program
The IZAR program consists of two global randomized, double-blind, placebo-controlled Phase 3 trials enrolling TNF-refractory patients and features Risankizumab as an active reference arm. Both trials assess multidomain outcomes, including musculoskeletal, skin, nail, and patient-reported measures. The IZAR-1 trial will continue through Week 52 to assess durability, with full readout expected in H1 2026. IZAR-2 is expected to complete enrolment in Q3 2026.
CEO Jorge Santos da Silva highlighted the significance of achieving broad efficacy across musculoskeletal, skin, and patient-reported outcomes simultaneously, noting the potential of Sonelokimab to become a next-generation therapy in PsA. CSO Prof. Kristian Reich added that the breadth of response supports the drug's ability to address the diverse manifestations of the disease.
Pipeline Outlook
Looking ahead, MoonLake also plans to report results from the Phase 2 P-OLARIS trial, which is evaluating the efficacy and safety of Sonelokimab 60 mg administered subcutaneously in patients with PsA and axial spondyloarthritis (axSpA). Results are expected at the end of 2026 or early 2027.
Beyond PsA and axSpA, Sonelokimab is being studied in hidradenitis suppurativa (HS) under the Phase 3 VELA program, with Biologics License Application (BLA) submission planned by September 2026.
MoonLake ended Q2 2026 with $537.0 million in cash, cash equivalents and short-term marketable debt securities and expects its runway to extend to mid-2028. An additional $400 million remains available through its Hercules Capital debt facility, supporting upcoming milestones.
MLTX has traded between $5.95 and $62.75 over the past year. The stock is currently trading at $17.10, down 6.53%.
For comments and feedback contact: editorial@rttnews.com
Economic News
What parts of the world are seeing the best (and worst) economic performances lately? Click here to check out our Econ Scorecard and find out! See up-to-the-moment rankings for the best and worst performers in GDP, unemployment rate, inflation and much more.
September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.