Modus Therapeutics Receives Approval to Initiate a Phase IIa Clinical Trial for Chronic Kidney Disease (CKD)

STOCKHOLM, SWEDEN – November 18, 2024: Modus Therapeutics Holding AB ("Modus") announces that it has received approval from the relevant authorities in Italy for its planned Phase IIa clinical trial with sevuparin.

As previously communicated, the planned Phase IIa study will be conducted in two parts. Part 1 aims to establish dosage levels and safety of sevuparin through single doses in 25-30 patients with varying degrees of kidney failure. Part 1 will also include a small reference group of healthy volunteers and may also provide an opportunity to assess early effects on hepcidin in a relevant patient population.

Part 2, the so-called "proof of concept" segment, will evaluate the effects of repeated dosing of sevuparin based on the dose levels established in Part I, focusing on endpoints related to anemia, hepcidin, kidney status, and relevant biomarkers in patients with more severe chronic kidney disease and anemia. It is expected to recruit 25-30 patients, bringing the total study enrollment to 50-60 patients. The approval is in line with Modus’ target to execute Part I of the study during the first half of 2025.