Resolution Therapeutics Limited, a clinical-stage biopharmaceutical company focused on macrophage cell therapies for end-stage liver disease, has announced key data presentations in collaboration with the University of Edinburgh at the EASL Congress 2024 in Milan, Italy. These presentations highlight the potential of macrophage cell therapy as a treatment for advanced liver cirrhosis.

The studies presented include:

1. Extended data from the MATCH Phase 2 clinical trial, presented by Dr. Paul Brennan from the University of Dundee and Professor Stuart Forbes, a scientific founder of Resolution Therapeutics and Professor of Transplantation and Regenerative Medicine at the University of Edinburgh.
2. Insights into the proprietary discovery platform for engineered macrophage cell therapies for end-stage liver disease, presented by Dr. Lara Campana, scientific co-founder and Vice President of Research Operations at Resolution Therapeutics.

Results from the MATCH Phase 2 study continue to demonstrate the safety and effectiveness of using autologous non-engineered macrophages in patients with compensated and decompensated liver cirrhosis, with baseline MELD scores from 10 to 16. After thirty months post-randomisation, which includes an 18-month extended follow-up period, the macrophage infusion group showed significantly better outcomes in patient survival (Chi-square=4.35; p=0.037) and transplant-free survival (Chi-square=7.07; p=0.0078). These outcomes reflect significant reductions in all-cause mortality and increases in transplant-free survival. Additional details about the MATCH study can be found under clinicaltrialsregister.eu, EudraCT Number: 2015-000963-15.

These results provide strong clinical evidence supporting macrophage cell therapy as a viable and long-lasting treatment option for advanced liver cirrhosis. Resolution Therapeutics holds exclusive rights to this technology and data, licensed from the University of Edinburgh and Edinburgh Innovations, the University's commercialization service.

The company has also developed a platform for engineering and cryopreserving autologous macrophages with a pro-regenerative phenotype, aimed at treating patients with end-stage liver disease. This platform features an advanced differentiation protocol and an automated process that improves manufacturing yields without compromising the phenotype. The data indicate successful engineering and cryopreservation methods that facilitate multiple doses from a single leukapheresis collection, resulting in reduced manufacturing time and improved yield.

Professor Forbes expressed optimism about the results from the MATCH Phase 2 study and its long-term follow-up. He emphasized the importance of continuing patient monitoring, with plans to present further data at the American Association for the Study of Liver Disease (AASLD) meeting in November 2024. He also noted the advancements in the macrophage production and engineering platform at Resolution Therapeutics as a crucial step forward in addressing this significant medical need.

Resolution's forthcoming Phase 1/2 EMERALD study will assess the safety and efficacy of the engineered macrophage cell therapy, RTX001, in patients with decompensated liver cirrhosis following recent hospitalization due to a decompensation event. The primary analysis will focus on safety and major clinical events, including all-cause mortality, with patient recruitment expected to begin in Q3 2024.

Dr. Lara Campana highlighted the efficacy and safety of autologous macrophages as a treatment for advanced liver cirrhosis and the goal of maximizing their pro-regenerative potential through advanced engineering and production platforms. This approach could potentially reduce the need for liver transplants and extend life expectancy for patients with end-stage liver disease.

Resolution Therapeutics, noted that the data presented at EASL underscore the solid scientific and clinical foundation of their approach. The engineered macrophage cell therapy platform has the potential to significantly improve outcomes for patients facing this severe unmet medical need. End-stage liver disease is the company's initial focus in their broader vision to address inflammatory organ diseases.

RTX001 is an engineered autologous macrophage cell therapy designed to enhance anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease. The therapy is engineered using a unique combination of therapeutic genes known to be expressed in macrophages, aimed at bolstering the modality's inherent regenerative properties for superior efficacy and durability. The RTX001 clinical development program currently includes two studies: the ongoing OPAL study, a multi-center natural history study in liver cirrhosis patients hospitalized for the first time with hepatic decompensation, and the upcoming Phase 1/2 EMERALD study, an open-label first-in-human study evaluating RTX001 with clinical events as the primary efficacy endpoint. The EMERALD study is expected to begin recruiting patients in the third quarter of 2024.

 

Source: prnewswire.com

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