Resolution Therapeutics has completed enrollment in EMERALD, its Phase I/II study of RTX001 in patients with end-stage liver disease and prior hepatic decompensation.
Fifteen patients have been dosed with RTX001, an engineered regenerative macrophage therapy incorporating IL-10 and MMP-9 intended to address inflammation and fibrosis.
RTX001 is administered via a peripheral IV outpatient infusion of less than 10 minutes and does not require pre-conditioning, bridging therapy, or lymphodepletion.
The company says it expects interim clinical data in the fourth quarter of 2026 and plans to initiate a pivotal U.S. study in 2027 following a pre-IND meeting with the U.S. Food and Drug Administration.
Research notes that the U.S. end-stage liver disease population exceeds 500,000 and faces high mortality and limited transplant-free survival after hepatic decompensation.
