Resolution Therapeutics Gets MHRA Nod for Phase I/II EMERALD Study of RTX001

Resolution Therapeutics Limited, a clinical-stage biopharmaceutical company, has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to begin a Phase I/II clinical trial for its lead candidate, RTX001. This candidate is an engineered macrophage cell therapy aimed at treating patients with decompensated liver cirrhosis.

The study, named EMERALD, will be an open-label trial and will focus on assessing the safety and efficacy of RTX001. The primary analysis will center on safety and significant clinical events, including mortality rates. Additionally, the study will evaluate biomarkers such as the Model for End-Stage Liver Disease (MELD) score, which helps gauge the severity of liver disease and prioritize patients for a transplant. The EMERALD study is scheduled to commence in the third quarter of 2024.

Dr. Clifford Brass, Chief Medical Officer of Resolution Therapeutics, expressed excitement about the MHRA's approval. He emphasized that this milestone validates the therapeutic potential of engineered macrophage cell therapy for treating end-stage liver disease. Dr. Amir Hefni, Chief Executive Officer, echoed these sentiments, stating that the approval reflects the dedication and expertise of their scientific and clinical teams. He highlighted that this step brings the company closer to its mission of improving outcomes for patients with inflammatory organ diseases through innovative macrophage cell therapy.

The MHRA approval follows the presentation of pivotal proof-of-concept data by the University of Edinburgh at the EASL Congress 2024. This data, derived from the extended MATCH Phase II study, demonstrated that non-engineered macrophage cell therapy could be an effective and durable treatment for advanced liver cirrhosis. Resolution Therapeutics also showcased its proprietary macrophage cell therapy platform at the congress. The platform involves engineering and cryopreserving autologous macrophages with a pro-regenerative phenotype to treat end-stage liver disease (ESLD).

To further disseminate their findings and progress, Resolution Therapeutics is hosting a R&D Webinar on June 28, 2024, featuring leading hepatologist Dr. Arun Sanyal. He is the Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University. The webinar aims to provide deeper insights into the company's research and its implications for liver disease treatment.

Resolution Therapeutics is a company focused on pioneering macrophage cell therapies to achieve transformative outcomes in inflammatory organ diseases. Their proprietary platform allows the engineering of autologous macrophages with unique pro-regenerative properties, aiming to deliver superior results for patients across a range of inflammatory organ diseases. The company's primary focus is on developing RTX001, a product candidate with first-in-class potential, backed by preclinical data showcasing its anti-fibrotic and anti-inflammatory benefits compared to non-engineered macrophages. Resolution Therapeutics is also exploring the application of its platform in treating other conditions beyond liver disease.

RTX001 is designed to enhance the natural regenerative properties of macrophages, offering increased anti-fibrotic and anti-inflammatory effects for patients with end-stage liver disease. The clinical development program for RTX001 includes two studies: the ongoing OPAL study, which is a multi-center natural history study aimed at generating novel data on disease trajectory, and the upcoming EMERALD study. The EMERALD study, an open-label first-in-human trial, will primarily measure clinical events as its key efficacy endpoint. This study is expected to start in the third quarter of 2024.

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