Press release
MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody® sonelokimab in active psoriatic arthritis
MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody® sonelokimab in active psoriatic arthritis Phase 2 study represents an
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[{"type":"text","content":"MoonLake Immunotherapeutics screens first patient in Phase 2 study of the Nanobody® sonelokimab in active psoriatic arthritis Phase 2 study represents an important step in psoriatic arthritis clinical development, assessing high threshold outcomes across joint and skin domains of this multi-faceted diseaseGlobal study to assess efficacy and safety of sonelokimab compared to placebo, with adalimumab as an active reference armSonelokimab is an investigational Nanobody® designed to treat inflammatory diseases by inhibiting IL-17A/A, IL-17A/F and IL-17F/F dimers that drive inflammation, directly target sites of inflammation and penetrate difficult-to-reach inflamed tissuesNew study follows the completion of a global Phase 2b study of sonelokimab in moderate-to-severe psoriasis which demonstrated a rapid and durable clinical response; Phase 2 “MIRA” study is already underway to evaluate sonelokimab in moderate-to-severe hidradenitis suppurativa ZUG, Switzerland, December 14, 2022 – MoonLake Immunotherapeutics AG (MoonLake; Nasdaq: MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that the first subject has been screened in the United States, in a Phase 2 clinical study of the Nanobody® sonelokimab in patients with active psoriatic arthritis (PsA). The global, randomized, double-blind, placebo-controlled study (M1095-PSA-201, “ARGO”) is designed to evaluate the efficacy and safety of different doses of sonelokimab compared to placebo, with adalimumab as an active reference arm, in approximately 200 patients with active PsA. The primary endpoint of the study is the American College of Rheumatology (ACR) 50 response defined as the percentage of participants achieving ≥50% improvement in signs and symptoms of disease from baseline, compared to placebo. The study will also include a range of secondary endpoints reflecting the heterogeneous and multi-faceted nature of the disease, including the assessment of skin clearance (including Psoriasis Area and Severity Index (PASI) 100), disability, enthesitis, pain, as well as other levels of ACR response (including ACR70). Recruitment is on-going, with the first sites being initiated in Europe and in the United States. Sonelokimab (M1095) is an investigational Nanobody® designed to treat inflammatory disease by inhib...