Part 1 of the study, conducted at leading nephrology centers in Italy, enrolled healthy volunteers and patients across the full spectrum of kidney function—from mild (CKD stages 1–2) to terminal disease (CKD stage 5). Single doses of sevuparin were administered, followed by comprehensive assessments of pharmacokinetics (PK), safety, and tolerability.

The data confirm that sevuparin was well tolerated at all dose levels, with no discontinuations due to adverse events, and no observed clinically significant safety trends. Based on these results, three sevuparin dose levels have been selected for use in Part 2, involving repeated dosing in patients with moderate to severe CKD (stages 3–5). No dose adjustment will be necessary for patients with mild CKD.

“With the submission of dose selection data for Part 2 of our Phase IIa study in CKD-associated anemia, Modus continues to execute its clinical development strategy with precision,” said John Öhd, CEO of Modus Therapeutics. “We remain on track to initiate Part 2 in Q4 2025 and look forward to advancing our efforts to establish sevuparin as a potential new therapeutic option for patients with limited treatment alternatives.”

The Phase IIa study is being conducted in collaboration with CRO partner Latis S.r.l., alongside the Centro Ricerche Cliniche di Verona/Policlinico G.B. Rossi in Verona, and the Nephrology & Dialysis Unit at Istituti Clinici Scientifici Maugeri in Pavia.