The trial is being conducted at two leading nephrology centers in Italy – Centro Ricerche Cliniche di Verona/Policlinico G.B. Rossi in Verona and the Nephrology & Dialysis Unit at Istituti Clinici Scientifici Maugeri, Pavia – in collaboration with the CRO Latis S.r.l. Part 1 assessed safety and establishes future dose levels after single dosing in patients with CKD stages 3, 4 and 5, as well as in a reference cohort of healthy volunteers. The results will underpin the planned protocol amendment with dose recommendations to the second part of the study which aims to evaluate the therapeutic potential upon repeated dosing of sevuparin (proof of concept) in the same patient type. Modus intends to initiate Part 2 in Q4 2025.

Completion of Part 1 of the Phase IIa study on schedule aligns with the Company’s financing strategy for Part 2. The Board on 26 June resolved on a fully secured rights issue of approximately SEK 28.3 million—subject to approval at an extraordinary general meeting on 29 July 2025—to fund the next part of the study.

“Completing enrollment in Part 1 on time is an important milestone and highlights the very successful collaboration with our clinical partners and contract research organizations,” said John Öhd, CEO of Modus Therapeutics.” We look forward to taking the next step with Part 2 later this year to demonstrate sevuparin’s potential as a new treatment for CKD patients with anemia.”