Modus Therapeutics Holding AB has commenced a Phase II clinical trial evaluating sevuparin for the treatment of anemia associated with chronic kidney disease (CKD). The first patient has been dosed at the Centro Ricerche Cliniche di Verona, Italy.
The Phase IIa study is designed to assess the safety and efficacy of sevuparin in patients with varying degrees of kidney impairment. The trial builds upon previously published data in HemaSphere, which demonstrated sevuparin's ability to reduce hepcidin levels, a key contributor to anemia in CKD.
Study Design and Objectives
The Phase IIa study is divided into two parts:
- Part 1: This segment will evaluate the safety and determine appropriate dose levels of sevuparin through single-dose administration in patients with varying degrees of kidney impairment, along with a small reference group of healthy volunteers.
- Part 2: This segment will focus on the effects of repeated dosing and clinical outcomes, including hemoglobin levels, kidney function, hepcidin levels, and other relevant biomarkers in patients with advanced CKD and anemia.
The study aims to enroll 50–60 patients in total, with the completion of Part 1 anticipated in the first half of 2025.
Scientific Rationale
Elevated hepcidin levels are known to contribute to iron dysregulation in CKD and chronic inflammation, exacerbating anemia. Preclinical studies and data from healthy volunteers, published in HemaSphere, showed that sevuparin significantly reduced hepcidin levels, with reductions of up to 72% observed at the highest dose. Further preclinical data presented at ASH 2023 demonstrated that sevuparin lowered hepcidin levels, improved anemia symptoms, and ameliorated kidney status in a mouse model of CKD.
Management Commentary
"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," said Johan Öhd, CEO of Modus Therapeutics. "We are excited by the scientific progress supporting our clinical strategy and look forward to sharing new data as the study progresses."
Sevuparin is a proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive, and anti-aggregate effects. It is a heparinoid with attenuated anti-coagulation features, allowing for higher doses without increased bleeding risk. Modus Therapeutics is currently testing both an IV formulation for in-patient administration and a subcutaneous formulation for ambulatory and home care administration.
