UK—Resolution Therapeutics Limited (Resolution), a clinical-stage biopharmaceutical company developing macrophage cell therapies, has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase I/II EMERALD study for its lead candidate RTX001.
The EMERALD study, which is an open-label Phase I/II trial, will investigate the safety and efficacy of the engineered macrophage cell therapy RTX001 in patients with decompensated liver cirrhosis.
The primary analysis of the study will focus on safety and major clinical events, including mortality rates.
In addition, the study will evaluate biomarkers such as the Model for End-Stage Liver Disease (MELD) score, which is used to assess disease severity and prioritize patients for a liver transplant.
The initiation of the EMERALD study is slated for Q3 2024, marking a pivotal step forward in the clinical development of RTX001.
This significant milestone comes at an exciting time in the company’s journey, following the presentation of key proof-of-concept data by the University of Edinburgh at the EASL Congress 2024.
The data from the extended MATCH Phase II study demonstrated clinical proof-of-concept for non-engineered macrophage cell therapy as an effective and durable treatment for advanced liver cirrhosis.
Furthermore, Resolution also presented its proprietary macrophage cell therapy platform, showcasing the engineering and cryopreservation of autologous macrophages with a pro-regenerative phenotype for treating end-stage liver disease (ESLD).
This innovative approach underscores the potential of their technology to provide new therapeutic options for patients suffering from severe liver conditions.
Commenting on the approval, Dr. Clifford Brass, Chief Medical Officer of Resolution Therapeutics, expressed his excitement and noted that receiving the MHRA’s green light to begin the Phase I/II EMERALD study for RTX001 marks a significant milestone in their program.
He emphasized that this approval underlines the therapeutic potential of engineered macrophage cell therapy for end-stage liver disease and reflects the company’s commitment to advancing innovative treatments.
In addition, Dr. Amir Hefni, Chief Executive Officer of Resolution Therapeutics, highlighted the dedication and expertise of their scientific and clinical teams.
He stated that this achievement is a testament to their outstanding efforts and brings them one step closer to realizing their mission: transforming outcomes for patients suffering from inflammatory organ diseases through macrophage cell therapy
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