Green light for engineered macrophage cell therapy study 


Resolution Therapeutics has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence a Phase I/II EMERALD study for its lead candidate RTX001 for patients with decompensated liver cirrhosis. 

EMERALD is an open-label, Phase I/II study which will investigate the safety and efficacy of RTX001. The primary analysis will focus on safety and major clinical events including death. The study will also evaluate biomarkers such as the Model for End-Stage Liver Disease (MELD) score which is used to assess disease severity and prioritise patients for a transplant. The EMERALD study will initiate in Q3 2024.  

The MHRA approval follows 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. Resolution also presented its proprietary macrophage cell therapy platform, demonstrating the engineering and cryopreservation of autologous macrophages with a pro-regenerative phenotype for the treatment of end stage liver disease (ESLD). 

Dr Clifford Brass, Chief Medical Officer of Resolution Therapeutics, commented: “This marks a significant milestone in our programme and underlines the therapeutic potential of engineered macrophage cell therapy for end-stage liver disease.” 

Dr Amir Hefni, Chief Executive Officer of Resolution Therapeutics, said: “This takes us one step closer to bringing our mission, to transform outcomes for patients suffering with inflammatory organ diseases through macrophage cell therapy, to the clinic.”

Megan Thomas, Multimedia Editor, DDW

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