Modus Therapeutics Holding AB has announced that the first patient has been dosed in part 2 of its ongoing Phase 2a clinical trial evaluating sevuparin for chronic kidney disease (CKD) with anemia.
This milestone follows the completion of part 1 earlier in 2025 and marks the start of the proof-of-concept phase. Part 2 initiation was preceded by a protocol amendment submitted in summer 2025 to finalize dose selection based on part 1 data. Regulatory approval came in autumn, with the first patient dosed roughly one month later.
Sevuparin, an investigational heparinoid, is designed to address unmet needs in CKD with anemia and potentially other chronic inflammatory conditions. The Phase 2a study, a central element of Modus’ clinical program, is structured in two parts.
Part 1, now complete, involved single-dose administration to assess safety and guide dose selection across varying degrees of renal impairment. Part 2 focuses on repeated doses, evaluating safety and clinically relevant outcomes such as hemoglobin and hepcidin levels, along with other kidney and blood biomarkers. The study is expected to enroll 50–60 patients across both parts.
Anemia is a common complication in CKD, worsening with disease severity and impacting both quality of life and prognosis. Inflammation-driven hepcidin increases can limit iron availability, reducing treatment responsiveness. Preclinical and translational data suggest sevuparin may lower hepcidin, potentially improving erythropoiesis and renal outcomes.
John Öhd, CEO of Modus Therapeutics, said, “Advancing into Part 2 with the first patient dosed is a major milestone for Modus and potentially for patients. Building on the safety and pharmacokinetic data from Part 1, we can now evaluate sevuparin’s impact on hemoglobin, hepcidin, and kidney-related biology in patients with advanced CKD and anemia.”
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