Modus Therapeutics has temporarily halted a Phase IIa research trial of sevuparin for chronic kidney disease (CKD) with anaemia after a "serious adverse event."
Modus said that the trial was paused voluntarily, not because a regulator stepped in.
The biotech company's shares reportedly halved after the announcement.
Modus stressed that the event — known as a suspected unexpected serious adverse reaction (SUSAR) — did not establish a causal relationship to the study drug, but that possibility cannot be excluded.
What is sevuparin?
Sevuparin is Modus' proprietary modified polysaccharide that has immunomodulating and anti-adhesive properties.
It is designed to act as a non-anticoagulant heparinoid.
The company is developing it across clinical trials as a treatment option for several major unmet medical needs, including anaemia, sepsis and sickle cell disease.
What was the trial investigating?
The study, conducted in Italy, was part of the company's CKD programme with anaemia and evaluated sevuparin in these patients with CKD.
Part one of the trial, which investigated single doses, was completed in 2025 with no discontinuations due to adverse events.
Part two evaluated repeated doses, examining safety and clinically relevant outcomes such as haemoglobin and hepcidin levels, along with other kidney- and blood-related biomarkers.
What happens next?
Modus said it was working with the study investigator and its safety committee to evaluate the available data and determine next steps, including assessing causality.
It added that it would provide "more definitive information on the expected impact on the timeline as soon as the ongoing assessment has been completed."
The pause will shift the proof-of-concept readout from around the turn of the year 2026/2027 to the first quarter of 2027.
“Patient safety is our highest priority. We have therefore chosen to temporarily pause enrollment while the event is evaluated," said John Öhd, CEO of Modus Therapeutics.
We are in close dialogue with the investigators, the study’s safety committee and the relevant authorities and will provide an update as soon as we have more information.
