Resolution Therapeutics Receives MHRA Approval to Commence Phase I/II EMERALD Study for Lead Candidate RTX001

EMERALD Study will investigate safety and efficacy of engineered macrophage cell therapy in patients with decompensated liver cirrhosis

LONDON and EDINBURGH, Scotland, June 27, 2024 /PRNewswire/ -- Resolution Therapeutics Limited ("Resolution"), a clinical-stage biopharmaceutical company developing macrophage cell therapies to treat end-stage liver disease today announces it 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.

EMERALD is an open-label, Phase I/II study which will investigate the safety and efficacy of engineered macrophage cell therapy, RTX001, in patients with decompensated liver cirrhosis. 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.

Dr Clifford Brass, Chief Medical Officer of Resolution Therapeutics, commented: "We are excited to have received approval from the MHRA to begin working on our Phase I/II EMERALD study for our lead candidate RTX001. This marks a significant milestone in our program 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: "Today's approval from the MHRA is a testament to our outstanding scientific and clinical teams. 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."

The U.K. MHRA approval 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. 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).

Resolution is hosting an R&D Webinar on Friday 28^th June 2024 at 12.30 BST / 07.30 EDT with world leading hepatologist, Arun Sanyal, M.D., Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. Please use the following link to register.  A replay will be available on the News page of the Resolution Website following the event's completion. 

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About Resolution Therapeutics

Resolution Therapeutics is a clinical-stage biopharmaceutical company pioneering macrophage cell therapy for transformative outcomes in inflammatory organ diseases. The Company leverages its proprietary platform to engineer autologous macrophages with distinct pro-regenerative properties as cell therapy medicines capable of delivering superior patient outcomes across the spectrum of inflammatory organ disease. Resolution's initial focus is on developing RTX001, its lead product candidate with first-in-class potential supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages, for patients diagnosed with end-stage liver disease. The Company is also advancing efforts to expand the potential of its platform beyond the liver into indications where engineered macrophages have therapeutic potential. Resolution Therapeutics is based in Edinburgh and London. Learn more by visiting https://resolution-tx.com/ and engage with us on LinkedIn.

About RTX001

RTX001 is an engineered autologous macrophage cell therapy designed to deliver increased anti-fibrotic and anti-inflammatory effects in patients with end-stage liver disease. The product candidate is engineered using a unique combination of therapeutic genes known to be expressed in macrophages to enhance the inherent regenerative properties of the modality for superior efficacy and durability. The clinical development program for RTX001 currently consists of two clinical studies. The ongoing OPAL study is a multi-center natural history study in patients with liver cirrhosis who have been hospitalised for the first time with hepatic decompensation. The objective of the OPAL study is to generate novel data on disease trajectory to optimise the control arm for the planned EMERALD study. The planned Phase I/II EMERALD study is an open-label first-in-human study of RTX001 measuring clinical events as the primary efficacy endpoint. The EMERALD study is expected to initiate as early as the third quarter of 2024.