Resolution Therapeutics spun out from the University of Edinburgh in 2020. Credit: Gorodenkoff / Shutterstock.com.

Edinburgh University spin-out Resolution Therapeutics has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a trial of its lead candidate RTX001 in patients with decompensated liver cirrhosis.

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.

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The candidate is supported by preclinical data demonstrating anti-fibrotic and anti-inflammatory advantages relative to non-engineered macrophages.

The Phase I/II open-label EMERALD study plans to measure clinical events as the primary efficacy endpoint. It also plans to evaluate biomarkers, including the Model for End-Stage Liver Disease (MELD) – a scale used to assess disease severity and prioritise patients for a transplant.

The company expects to begin enrolling patients for the study in Q3 2024.

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EMERALD is the second clinical study from Resolution Therapeutics. The company’s ongoing OPAL clinical study, a multi-centre natural history study in patients with liver cirrhosis who have been hospitalised for the first time with hepatic decompensation, is intended to generate novel data on disease trajectory to optimise the control arm for the EMERALD study.

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“Today’s approval from the MHRA is a testament to our outstanding scientific and clinical teams,” said Resolution Therapeutics CEO Dr Amir Hefni. “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.”

Resolution Therapeutics approval from the MHRA follows the presentation of key proof of concept data by the University of Edinburgh at the European Association for the Study of the Liver (EASL) Congress 2024 which took place from 5 to 8 June in Milan, Italy.

Resolution Therapeutics spun out from the University of Edinburgh in 2020.

Edinburgh University presented data at EASL from its MAcrophage Therapy for Liver Cirrhosis (MATCH) Phase II study (ISRCTN10368050), which demonstrated clinical proof of concept for non-engineered macrophage cell therapy as an effective and durable treatment for advanced liver cirrhosis.

There are currently more than 2,000 clinical trials underway in liver cirrhosis and related indications, as per GlobalData’s Clinical Trials database.

GlobalData is the parent company of Clinical Trials Arena.

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