The Stockholm-based company made the decision voluntarily, as a precaution, after the event was reported to regulators as a suspected unexpected serious adverse reaction (SUSAR) and reviewed with the study’s safety committee. The pause was not ordered by any regulatory authority.

A SUSAR classification means that a link to the study drug cannot be ruled out, not that one has been established. No other patients were receiving treatment at the time, so no ongoing treatment had to be stopped. Modus is now reviewing the available data with the investigators and the safety committee, including whether the drug caused the event.

“Patient safety is our highest priority. We have therefore chosen to temporarily pause enrollment while the event is evaluated. 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,” says John Öhd, CEO, Modus Therapeutics.

The open-label study is being run at two nephrology centers in Italy and includes patients with CKD stages 3–5. Part 1, which tested single doses, was completed in 2025 with no discontinuations due to adverse events. The readout had previously been expected around the turn of the year.

Modus expects its cash, including proceeds from the directed share issue in September 2026, to fund operations into the second quarter of 2027. The company will present an updated financing assessment in its third-quarter interim report on November 24, 2026.