Modus Therapeutics Holding AB has announced that the first patient has been dosed in part 2 of its ongoing phase 2a clinical study evaluating sevuparin for the treatment of chronic kidney disease (CKD) with anemia.
The milestone follows the completion of part 1 earlier in 2025 and marks the start of the proof-of-concept phase.
The company confirmed that the initiation of part 2 was preceded by a protocol amendment submitted during the summer of 2025 to finalise dose selection based on data from part 1. Regulatory approval of the amendment was granted in the autumn, with the first patient dosed approximately one month later.
The study is a central element of Modus’ clinical development programme for sevuparin, an investigational heparinoid designed to address unmet medical needs in CKD with anemia and potentially other chronic inflammatory conditions.
The phase IIa study is structured in two parts. Part 1, now completed, involved single-dose administration to assess safety and support dose selection across varying degrees of renal impairment.
Part 2, currently underway, is focused on repeated-dose evaluation, examining safety and clinically relevant outcomes such as haemoglobin and hepcidin levels, alongside other kidney and blood-related biomarkers in patients with advanced CKD and anemia. Across both parts, the study is expected to enrol 50–60 patients.
Anemia is a common complication in CKD, worsening with disease severity and affecting both quality of life and prognosis. Inflammation-driven increases in hepcidin can restrict iron availability, contributing to anemia and reduced treatment responsiveness. Preclinical and translational data suggest sevuparin may lower hepcidin, offering a mechanistic rationale to improve erythropoiesis and renal outcomes.
John Öhd, CEO of Modus Therapeutics, said: “Advancing into Part 2 with first patient dosed is a major milestone for Modus and potentially for patients in the future. 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.”
