Resolution Therapeutics has announced the approval of its clinical trial application by the Spanish Agency of Medicines and Medical Products (AEMPS) to expand the Phase 1/2 EMERALD study of RTX001 into Spain. This trial aims to assess the safety and efficacy of RTX001, an engineered macrophage cell therapy, in patients suffering from end-stage liver disease.
EMERALD Study Design
The EMERALD study is an open-label, first-in-human Phase 1/2 trial. It will primarily focus on evaluating the safety profile of RTX001 and monitoring major clinical events, including mortality. Secondary endpoints include the evaluation of biomarkers, such as the Model for End-Stage Liver Disease (MELD) score, which is crucial for assessing disease severity and prioritizing patients for liver transplantation.
RTX001: Engineered Macrophage Therapy
RTX001 is an autologous regenerative macrophage therapy engineered to enhance anti-fibrotic and anti-inflammatory effects. The therapy involves engineering macrophages with IL-10-MMP9 mRNA to amplify their natural regenerative capabilities, potentially leading to improved efficacy and sustained therapeutic benefits. Preclinical data presented at The Liver Meeting 2024 demonstrated the superior anti-fibrotic and anti-inflammatory effects of IL-10-MMP9 engineered macrophages compared to their non-engineered counterparts.
Clinical Development and Expansion
The EMERALD study has already received authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), with patient recruitment initiated in the UK in October 2024. The expansion into Spain is anticipated to commence in the second quarter of 2025. Dr. Clifford Brass, Chief Medical Officer of Resolution Therapeutics, expressed enthusiasm about the AEMPS approval, highlighting the momentum Resolution aims to build in 2025 to deliver macrophage therapies for inflammatory and fibrotic diseases.
Resolution Therapeutics' Focus
Resolution Therapeutics is dedicated to pioneering regenerative macrophage therapies for inflammatory and fibrotic diseases. Their approach involves leveraging a proprietary platform to develop macrophages with pro-regenerative properties, aiming for superior patient outcomes. The company's initial focus is on RTX001 for treating end-stage liver disease, with ongoing efforts to extend the platform to other indications, including graft-vs-host disease (GVHD) and lung fibrosis.
