Resolution Therapeutics Reveals Breakthrough Data for Macrophage Cell Therapy in End-Stage Liver Disease at EASL 2024

June 5, 2024 -- Resolution Therapeutics Limited ("Resolution"), a company engaged in developing macrophage cell therapies for treating end-stage liver diseases, recently presented significant findings at the EASL Congress 2024, held in Milan, Italy. The data underscored the high potential of macrophage cell therapy as a treatment for advanced liver cirrhosis.

Key findings were showcased in two posters:
1. Extended MATCH Phase 2 clinical data presented by Dr. Paul Brennan from the University of Dundee and Professor Stuart Forbes, scientific founder of Resolution Therapeutics and Professor of Transplantation and Regenerative Medicine at the University of Edinburgh.
2. The proprietary discovery platform for engineered macrophage cell therapies for end-stage liver disease (ESLD) by Dr. Lara Campana, scientific co-founder and Vice President of Research Operations at Resolution Therapeutics.

The MATCH Phase 2 study continues to demonstrate the safety and efficacy of autologous non-engineered macrophages in patients with liver cirrhosis, showing significant improvements in patient survival and transplant-free survival after thirty months post-randomization. The macrophage infusion group exhibited better outcomes in terms of overall survival (Chi-square=4.35; p=0.037) and transplant-free survival (Chi-square=7.07; p=0.0078), with a notable reduction in all-cause mortality. These results provide robust evidence of the effectiveness and durability of macrophage cell therapy for advanced liver cirrhosis. Resolution Therapeutics holds exclusive rights to the technology and data, licensed from the University of Edinburgh and Edinburgh Innovations.

Additionally, Resolution has developed a platform to engineer and cryopreserve autologous macrophages with pro-regenerative traits for ESLD treatment. The platform shows an improved differentiation protocol and automated processes that enhance manufacturing yields. Furthermore, it includes engineering and cryopreservation methods that enable multiple doses from a single leukapheresis collection, resulting in reduced manufacturing time, increased yield, and a more consistent process.

Professor Stuart Forbes expressed optimism about the long-term data from the MATCH Phase 2 study, highlighting the potential of the macrophage production and engineering platform to address this severely underserved condition. The company plans to continue monitoring patients and aims to present further data at the American Association for the Study of Liver Disease (AASLD) meeting in November 2024.

Resolution's upcoming Phase 1/2 EMERALD study will evaluate the safety and efficacy of 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 outcomes, including all-cause mortality, with patient recruitment expected to begin in Q3 2024.

Dr. Lara Campana emphasized the safety and effectiveness of autologous macrophages for treating advanced liver cirrhosis, citing the advanced macrophage engineering and production platform's potential to enhance regenerative properties and reduce the need for liver transplants, thereby extending the life expectancy of ESLD patients.

Dr. Amir Hefni, Chief Executive Officer of Resolution Therapeutics, highlighted the data presented at EASL as further evidence supporting their approach. He emphasized that their engineered macrophage cell therapy platform has the potential to transform outcomes for patients with high unmet needs, with ESLD as the first target in their broader strategy to treat inflammatory organ diseases.

Resolution Therapeutics is a clinical-stage biopharmaceutical company pioneering macrophage cell therapy for inflammatory organ diseases. Their proprietary platform engineers autologous macrophages to enhance regenerative properties, aiming to deliver superior patient outcomes. The company's lead product candidate, RTX001, shows promise in preclinical studies for its anti-fibrotic and anti-inflammatory benefits, and they are also exploring the platform's potential beyond liver diseases.

RTX001 is designed to deliver enhanced anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease. The clinical development program currently includes two studies: the ongoing OPAL study, which aims to generate data on disease trajectory for optimizing the EMERALD study's control arm, and the planned Phase 1/2 EMERALD study, expected to begin in the third quarter of 2024.

The University of Edinburgh, a globally recognized institution, and Edinburgh Innovations, its commercialization service, play a critical role in advancing these medical innovations. EASL, the European Association for the Study of the Liver, supports excellence in liver research and clinical practice, with 5,300 members from 112 countries as of 2023.

The promising data from Resolution Therapeutics signifies a potential breakthrough in the treatment of liver cirrhosis, with ongoing studies expected to further validate these findings and potentially improve patient outcomes in this challenging field.

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