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Modus Therapeutics Initiates Phase II Study with Sevuparin for the Treatment of Chronic Kidney Disease with Anemia
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Stockholm, December 9, 2024 - Modus Therapeutics Holding AB (“Modus”) today announced that the first dose has been administered in the company’s Phase II clinical study evaluating the drug candidate sevuparin for the treatment of chronic kidney disease (CKD) with associated anemia. The study is being conducted at the Centro Ricerche Cliniche di Verona, Italy.
This milestone builds in part upon promising preclinical and clinical data recently published in the scientific journal HemaSphere. The article highlights sevuparin’s ability to significantly reduce hepcidin levels—a key regulator of iron metabolism and a crucial contributor to the development of CKD-related anemia—further reinforcing the scientific foundation for the study.
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 expected to enroll a total of 50–60 patients, with the completion of Part 1 planned for the first half of 2025.
Scientific Background
Research has demonstrated that elevated hepcidin levels contribute to iron dysregulation in CKD and chronic inflammation, exacerbating the anemia that occurs in these conditions. In the HemaSphere article, sevuparin was shown to significantly reduce hepcidin levels in both preclinical models and healthy volunteers, achieving reductions of up to 72% at the highest dose. Furthermore, in a preclinical disease model for CKD with anemia presented by Modus at the conference ASH 2023, sevuparin was found to lower hepcidin, treat anemia symptoms and ameliorate the kidney status in mice with CKD. These results, combined with its favorable safety profile, support sevuparin’s potential as an innovative treatment option for patients with limited alternatives today.
Comment from CEO Johan Öhd
“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.”