Modus reported data from a double-blind, placebo-controlled study (NCT03853421) to evaluating the safety and tolerability of sevuparin in healthy volunteers. Credit: Vladmir Vladimirov / Getty Images

Modus Therapeutics is considering a new Phase IIa clinical program of sevuparin in patients with anaemia of chronic diseases after presenting new results from a Phase I study.

Modus reported data from a double-blind, placebo-controlled study (NCT03853421) evaluating the safety and tolerability of sevuparin in healthy volunteers. The trial led to plasma hepcidin decreases of to 30-50% of baseline values in the presence of sevuparin at three different dose levels, with maximal suppression between 6 to 24 hours.

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The Swedish company reported the data at the 2023 European Haematology Association (EHA) Annual Congress, which took place from June 8–11 June in Frankfurt, Germany.

Sevuparin is a low-molecular weight heparinoid with substantially reduced anticoagulant activity, which can be to control hepcidin expression in patients. High levels of hepcidin are considered to be involved in the onset and progression of the type of anaemia that often complicates chronic kidney disease and chronic inflammatory diseases.

Sevuparin is already being developed as a potential treatment for malaria, sepsis, and septic shock, with updates on clinical trial expected in the second half of 2023.

Sevuparin’s Phase I data

Sevuparin in a time and dose dependant mechanism suppressed hepcidin expression, both basal and BMP-6 induced, in the HepG2 cells.

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Furthermore, in healthy volunteers, subcutaneously administered sevuparin caused a significant reduction of about 80% (9 mg/kg) and 50% (3 mg/kg) of serum hepcidin after 12 and 24 hours, respectively, with human in vivo IC50 values reflecting those in cells.

“These data reinforce the potential for a new Phase IIa ready clinical program in patients with chronic disease anaemia such as chronic kidney disease. As we move into the second half of 2023, we look forward to providing further updates on this project alongside our planned clinical study in sepsis” said John Öhd, CEO of Modus Therapeutics.