Resolution Therapeutics has completed enrollment in its phase 1/2 EMERALD trial evaluating RTX001, an engineered regenerative macrophage therapy (RMT), in patients with end-stage liver disease (ESLD) and a history of decompensated liver cirrhosis, the company announced September 11, 2026.¹ A total of 15 patients were dosed with RTX001, and interim clinical data are expected in the fourth quarter of 2026.
Key facts
- Drug: RTX001 (Resolution Therapeutics)
- Class: Engineered regenerative macrophage therapy (IL-10 + MMP-9)
- Indication studied: End-stage liver disease (ESLD), decompensated cirrhosis history
- Trial: Phase 1/2 EMERALD; 15 patients dosed; enrollment complete
- Milestone: Interim data expected Q4 2026
- Administration: Peripheral IV infusion, <10 minutes, no pre-conditioning required
- Prior data: MATCH trial; 70% 4-year transplant-free survival vs 40% standard care
- Manufacturing: Cost of goods reduced 40% to date via process refinements
- Regulatory status: US pivotal study planned for 2027, pending pre-IND FDA meeting
- Disease burden: >500,000 US ESLD patients; projected 600,000 by 2040
"Dosing the final patient in the EMERALD trial marks a significant milestone for Resolution Therapeutics and reflects our progress toward a potential new treatment paradigm for end-stage liver disease," said Amir Hefni, PhD, CEO of Resolution Therapeutics, in a company press release.¹ "Patients with this condition face very limited options beyond transplantation and symptom management, and RTX001 has the potential to offer a differentiated, transformational therapeutic approach. We are working with urgency to advance the clinical program and bring this therapy closer to the patients who need it."
What is the EMERALD trial evaluating?
EMERALD is a multicenter, single-arm, first-in-human, open-label trial evaluating the safety and efficacy of RTX001 in patients with ESLD who have recovered from a recent hepatic decompensation, conducted at hepatology centers across the UK and Spain. RTX001 is engineered with interleukin-10 (IL-10) and matrix metalloproteinase-9 (MMP-9) to enhance the anti-inflammatory and anti-fibrotic effects of regenerative macrophage therapy. The therapy is administered via peripheral intravenous infusion in under 10 minutes, requiring no pre-conditioning, bridging therapy, or lymphodepletion.¹ In preclinical studies, engineering macrophages with IL-10 and MMP-9 produced a significantly greater reduction in systemic inflammation than non-engineered macrophages in mouse models of liver fibrosis.²
What clinical evidence supports RTX001's approach?
RTX001 builds on an earlier, non-engineered version of regenerative macrophage therapy tested in a phase 2 trial (MATCH), led by Resolution co-founder Stuart Forbes, MB CHB, FRCP(Ed), PhD, at the University of Edinburgh.¹,³ In 4-year follow-up data from the MATCH trial, 70% of patients who received macrophage therapy were alive without a liver transplant, compared with 40% of those who received standard care, with a favorable safety profile and no evidence of increased serious adverse events.³
Why is a new treatment needed for end-stage liver disease?
Liver transplantation remains the only disease-modifying treatment for ESLD, but access is severely constrained by limited transplant centers, donor availability, and the complexity and cost of surgery.¹ The US ESLD patient population exceeds 500,000 and is expected to grow to 600,000 by 2040. Following a patient's first decompensation, disease progresses to death in 37% of cases or liver transplant in 5% of cases within 2 years, and median survival falls from 2 years after a first decompensation to 9 months after a second.¹
What's next for RTX001?
Resolution plans to initiate a pivotal study for RTX001 across the United States in 2027, following a pre-investigational new drug meeting with FDA, after which the company will finalize the pivotal study design and select clinical trial sites.¹ The company said ongoing manufacturing process refinements have reduced RTX001's cost of goods by 40% to date, and it is also advancing earlier-stage regenerative macrophage therapy programs in lung fibrosis and an in vivo RMT platform.¹
What are the limitations?
EMERALD is a single-arm, open-label trial without a placebo or active comparator, so its results cannot be directly attributed to RTX001 alone with the same certainty as a randomized trial. Interim data have not yet been reported, and the MATCH trial results supporting RTX001's scientific rationale come from a non-engineered predecessor therapy, not RTX001 itself.
References
- Resolution Therapeutics. Resolution Therapeutics completes enrollment in Phase I/II EMERALD clinical trial evaluating RTX001 in end-stage liver disease. Press release. Published September 11, 2026. Accessed September 11, 2026. https://resolution-tx.com/resolution-therapeutics-completes-enrollment-in-phase-i-ii-emerald-clinical-trial-evaluating-rtx001-in-end-stage-liver-disease/
- Resolution Therapeutics. Resolution Therapeutics announces new data showcasing the potential of regenerative macrophage therapy in treating cirrhosis at AASLD 2025. Press release. Published November 7, 2025. Accessed September 11, 2026. https://resolution-tx.com/resolution-therapeutics-announces-new-data-showcasing-the-potential-of-regenerative-macrophage-therapy-in-treating-cirrhosis-at-aasld-2025/
- Brennan P, Kilpatrick A, Glover A, et al. Autologous macrophage therapy increases transplant-free survival in cirrhosis: long-term follow-up of a phase 2 clinical trial. Cell Stem Cell. 2026;33(7):1098-1109.e3. doi:10.1016/j.stem.2026.04.016
