Leicester researchers have successfully completed recruitment to a Phase 2 clinical trial evaluating a novel, first‑in‑class therapy for COPD‑induced muscle weakness and sarcopenia – an area where no approved pharmacological treatments currently exist.
The Chief Investigator on the study, Honorary Consultant Respiratory Physician Dr Neil Greening from University Hospitals of Leicester NHS Trust explains: “Sarcopenia is the progressive loss of muscle strength and physical function. It occurs frequently in the COPD patients that we see in respiratory clinics, and contributes significantly to frailty, loss of independence and increased risk of adverse health outcomes. This is especially true when people with COPD are admitted unwell to hospital, where they can experience rapid loss of muscle and physical function.
“An effective therapy targeting sarcopenia in these patients could improve recovery from hospitalisation, long-term outcomes and quality of life for many people, which is why this trial is so vital.”
In partnership with Rejuvenate Biomed and funded by Wellcome Leap, the MINT-COPD Phase 2 trial is evaluating RJx‑01, which has been developed to target key biological drivers of muscle decline including inflammation, mitochondrial dysfunction and neuromuscular impairment.
A participant on the MINT-COPD trial, Jean Toon, 74 from Birstall in Leicester, said: “I was diagnosed with COPD a number of years ago, after struggling to catch my breath and experiencing tiredness and fatigue. I was approached to take part in the study when I was in hospital, and just thought I would go for it.
“My philosophy is that if I don’t benefit directly, someone in the future will benefit from me doing it.
“It was a real pleasure to be part of it. The weekly visits, tests and exercises all put my mind at rest that I was being looked after, whether I was on the placebo or taking the real medicine.”
This work highlights the strength of the Leicester BRC model in translating scientific innovation into real‑world clinical studies, enabling patients to access cutting‑edge therapies while shaping the future design of global trials.
Topline results, expected in early 2027, have the potential to inform new treatment pathways and improve outcomes for patients with COPD and wider populations affected by muscle loss.
About the MINT-COPD Phase 2 Trial
- Randomized, double-blind, placebo-controlled
- Evaluates safety, tolerability, muscle strength, physical function and fatigue resistance
- Previous Phase 1b study showed improvements in these outcomes with strong safety
RJx-01 targets multiple biological pathways, including:
- Mitochondrial dysfunction
- Inflammation
- Fibrosis
- Neuromuscular impairment
The trial is conducted through a partnership between:
- Rejuvenate Biomed
- University of Leicester
- NIHR Leicester Biomedical Research Centre
It is led by Dr Neil Greening and Dr Hamish McAuley and supported by Wellcome Leap funding.
About Rejuvenate Biomed
Rejuvenate Biomed is an AI-enabled biopharmaceutical company focused on combination therapies for age-related diseases.
Its lead drug, RJx-01:
- Has shown strong safety and tolerability
- Improves muscle strength and function in early trials
- Uses a multi-pathway mechanism
Phase 2 results are expected by the end of 2026. The company also uses proprietary AI platforms to identify future therapies.
About Wellcome Leap
Wellcome Leap is a global initiative funding large-scale, interdisciplinary programmes to deliver major health breakthroughs within 5–10 years.