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
28th 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.
Notes for Editors:
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.
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SOURCE Resolution Therapeutics