Resolution Therapeutics Announces Positive Interim Phase I/II EMERALD Data for Regenerative Macrophage Therapy RTX001 in End-Stage Liver Disease

• Six-month interim data showed a 42% relative risk reduction in death, liver transplant or hepatic decompensation versus an external control
• RTX001 was well tolerated with no infusion-related serious adverse reactions; biomarker analyses demonstrated suppression of key inflammatory pathways and reduced fibrogenesis
• Positive interim results support advancement of RTX001 towards a planned U.S. pivotal trial, with a pre-IND meeting with the FDA scheduled for December 2026
  

LONDON, Nov. 05, 2026 (GLOBE NEWSWIRE) -- Resolution Therapeutics Limited (“Resolution”), a clinical-stage biopharmaceutical company pioneering engineered Regenerative Macrophage Therapy (RMT) in inflammatory and fibrotic diseases, today announced positive interim six-month data from its Phase I/II EMERALD trial evaluating RTX001, an investigational autologous engineered RMT, in patients with end-stage liver disease (ESLD).

The data showed a signal of efficacy on clinical outcomes of death, liver transplant and hepatic decompensation. RTX001 was well tolerated, with no infusion-related serious adverse reactions and no severe adverse events related to treatment. Prospectively defined biomarkers showed reductions in markers of inflammation and fibrogenesis in line with the predicted mechanism of regenerative macrophages. The data are being presented as a late-breaker at The Liver Meeting® 2026 of the American Association for the Study of Liver Diseases (AASLD) in Denver, Colorado.

Amir Hefni, Chief Executive Officer of Resolution Therapeutics, said: “These interim results show RTX001 has the potential to change the trajectory for patients with end-stage liver disease, who currently have very limited treatment options beyond liver transplantation. These findings further support our belief in the transformative opportunity with Regenerative Macrophage Therapy to redefine how this and other inflammatory and fibrotic diseases are treated. We look forward to discussing the program with the FDA and advancing RTX001 toward a planned U.S. pivotal trial.”

Professor Jonathan Fallowfield, Chair of Translational Liver Research at the University of Edinburgh and Chief Investigator of EMERALD, said: “Patients with end-stage liver disease face a high risk of mortality, yet disease-modifying treatment options remain limited, with liver transplantation an option for only a minority. These interim data provide encouraging evidence that RTX001 may improve outcomes in this highly vulnerable patient population. Importantly, the results are broadly consistent with the clinical outcomes reported at four years in the University of Edinburgh's MATCH trial, which evaluated non-engineered macrophages in patients with less advanced liver disease. I am excited to share these findings at this year’s AASLD Liver meeting.”

Interim Comparative Analysis of EMERALD and OPAL Studies
Both studies enrolled patients with ESLD, recently recovering from a hepatic decompensation event. The six-month interim analysis compared the first nine of 15 patients treated with RTX001 in EMERALD (NCT06823713) to all 21 standard-of-care patients in OPAL (NCT06380335), Resolution’s natural history control. Site participation and enrollment criteria were closely aligned between both studies.

Efficacy
Two of nine RTX001-treated patients (22%) experienced a clinical outcome of death, liver transplant or a protocol-defined hepatic decompensation event within six months of first dose, compared with eight of 21 (38%) in OPAL, representing a 42% relative risk reduction. Transplant or death alone occurred in 11% of RTX001-treated patients versus 19% in OPAL.

Safety and Tolerability
RTX001 dosing was well tolerated with no infusion-related serious adverse reactions and no severe adverse events related to treatment. Peri-infusion vital signs were stable during all the infusions, which included up to four doses per patient.

Biomarker Findings
Pharmacodynamic biomarker analyses showed reduced activity of key inflammatory pathways and significant reductions in markers of fibrogenesis. Markers of fibrosis remodeling activity were maintained at interim analysis. These marked changes in biomarkers are consistent with RTX001’s design and mechanism of action, indicating a shift towards a more favorable anti-inflammatory and anti-fibrotic profile in ESLD patients, one permissive to liver regeneration, an advantage of engineered RMTs.

Dr. Clifford Brass, Chief Medical Officer of Resolution Therapeutics, said: “These interim results show that RTX001, engineered for superior anti-inflammatory and anti-fibrotic efficacy, is well tolerated and acts on the biology it was designed to target. Preliminary biomarker data show reduced inflammatory activity and lower markers of fibrogenesis. Together with a 42% relative risk reduction in death, liver transplant or hepatic decompensation versus our external control, these findings are consistent with the engineered mechanism of RTX001 and highlight its potential to deliver profound patient impact.”

Based on these results, Resolution seeks to advance RTX001 into a planned pivotal trial and has been granted a pre-IND meeting with the U.S. Food and Drug Administration (FDA) in December 2026. EMERALD has completed enrollment, with 15 patients dosed, and primary analysis in 2028.

AASLD 2026: Late-Breaking Presentation (Poster 5034)

• Title: Regenerative Macrophage Therapy (RMT) in End-Stage Liver Disease: Early Results from the EMERALD/OPAL Trials
• Presenter: Professor Jonathan Fallowfield
• Session: Late-Breaking Posters
• Date/Time: Sunday, November 8, 2026, 1:00–2:00 p.m. MST

AASLD 2026: Oral Presentation (Abstract 0176)

• Title: Suitability of intravenous administration of Regenerative Macrophage Therapy for the treatment of decompensated cirrhosis
• Presenter: Dr. Lara Campana, Senior Vice President, Head of Research and Translational Science
• Session: Industry Research Showcase
• Date/Time/Location: Saturday, November 7, 2026, 8:30–8:45 a.m. MST, Bluebird Ballroom 1B

The full late-breaking abstract is available on the Resolution website. To meet the leadership team, visit Booth 2266, Upper Level Exhibit Hall, or email contact@resolution-tx.com.

Notes to Editors

About EMERALD and OPAL
EMERALD (NCT06823713) is a multicenter, open-label Phase I/II trial of RTX001 in patients with ESLD, recently recovering from a hepatic decompensation event. The primary endpoint is safety and tolerability; key secondary endpoints are death, liver transplant and protocol-defined hepatic decompensation. OPAL (NCT06380335) is an observational natural history, external control study in which patients receive standard of care, using similar selection criteria at primarily the same sites as EMERALD. Both EMERALD and OPAL are fully enrolled.

About end-stage liver disease (ESLD)
ESLD, or decompensated cirrhosis, is the most advanced stage of chronic liver disease, in which patients experience significant and serious symptoms as the liver can no longer perform its essential functions. Once a patient develops ESLD, median survival falls to approximately two years¹. Liver transplantation is the only curative option today, but most patients who require a transplant do not receive one. ESLD causes more than 50,000 deaths in the U.S. each year and is the ninth leading cause of death nationally². There is no approved disease-modifying therapy for ESLD; current treatments focus on controlling symptoms rather than helping the liver recover and regenerate.

About RTX001
RTX001 is an investigational autologous engineered Regenerative Macrophage Therapy. Macrophages derived from the patient’s own monocytes are engineered with mRNA encoding IL-10 and MMP-9 to enhance their anti-inflammatory and anti-fibrotic activity, with the aim of enabling liver regeneration. RTX001 is simpler to administer than other types of cell therapy currently used in clinical practice such as CAR-T, requiring no lymphodepletion or conditioning, supporting outpatient and community delivery. RTX001 builds on the University of Edinburgh’s MATCH studies of non-engineered macrophages, in which treatment reduced the risk of death or transplant over four years in compensated cirrhosis (hazard ratio 0.39)³. Fifty patients have now received Regenerative Macrophage Therapy across three clinical studies.

About Resolution Therapeutics
Resolution Therapeutics is a clinical-stage biopharmaceutical company pioneering Regenerative Macrophage Therapy in inflammatory and fibrotic diseases. Its lead product, RTX001, is an engineered RMT with first-in-class potential in end-stage liver disease, supported by clinical and preclinical data showing enhanced anti-inflammatory and anti-fibrotic activity compared with non-engineered macrophages. Resolution is also extending its RMT platform beyond the liver, including lung fibrosis and an in vivo modality. A spinout company based on Professor Stuart Forbes’s research at the University of Edinburgh, Resolution is based in the UK (Edinburgh and London) and the U.S. Learn more at resolution-tx.com and engage with us on LinkedIn.

Contacts

Resolution Therapeutics: Thivyan Thayaparan, Director of Strategy, contact@resolution-tx.com

Media, Optimum Strategic Communications: Stephen Adams, Joshua Evans, Aoife Minihan, resolution@optimumcomms.com, +44 (0) 20 3821 6420

References

1. D’Amico G, et al. EASL Congress 2023 (also D’Amico, et al., J Hepatol 2006)
2. CDC WONDER, 1999–2023 Am J Gastroenterol. 2025
3. Brennan PN, et al. Cell Stem Cell 2026