“The initiation of this Phase II study marks an important milestone for Modus Therapeutics and our development of sevuparin as a potential new treatment for patients with CKD-related anemia. We are excited by the scientific progress supporting our clinical strategy and look forward to sharing new data as the study progresses,” says CEO Johan Öhd.

Study design and objectives

The Phase IIa study consists of two parts. Part 1 evaluates the safety and determines dose levels of sevuparin through single-dose administration in patients with varying degrees of kidney impairment, alongside a small reference group of healthy volunteers. Part 2 focuses on the effects of repeated dosing and clinical outcomes, including hemoglobin levels, kidney function, hepcidin levels, and other biomarkers in patients with advanced CKD and anemia.

The study is being conducted at the Centro Ricerche Cliniche di Verona, Italy.

The study is expected to enroll a total of 50–60 patients, with the completion of Part 1 planned for the first half of 2025.