Rejuvenate Biomed Completes Recruitment in Phase 2 Trial Assessing First-in-Class Multi-Pathway Therapeutic RJx-01 in COPD-Induced Sarcopenia
- Fully recruited Phase 2 trial evaluates RJx-01 in older adults with COPD-induced muscle weakness and sarcopenia, an area with no approved pharmacologic treatments
- RJx-01 offers a multi-pathway approach targeting several drivers of muscle decline, including mitochondrial dysfunction, inflammation, fibrosis and neuromuscular impairment
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Topline data expected by year-end 2026 represents a near-term clinical inflection point for Rejuvenate Biomed’s lead asset and further platform validation
DIEPENBEEK, Belgium, June 01, 2026 (GLOBE NEWSWIRE) -- Rejuvenate Biomed, a clinical-stage biopharmaceutical company developing combination therapeutics for age-related diseases, announced today that it has completed recruitment in its randomized, double-blind, placebo-controlled Phase 2 trial MINT-COPD evaluating RJx-01, its lead investigational therapy, in patients with chronic obstructive pulmonary disease (COPD)-induced muscle weakness and sarcopenia. The expected topline data from this Phase 2 trial will provide important insights to shape future sarcopenia trial designs and represent a key value-creation milestone for Rejuvenate Biomed.
“Completing recruitment brings RJx-01 closer to an important clinical and strategic inflection point,” said Ann Beliën, PhD, Founder and Chief Executive Officer of Rejuvenate Biomed. “Sarcopenia remains a major unmet medical need with no approved therapies. COPD-induced sarcopenia represents a clinically meaningful entry point into the broader sarcopenia treatment landscape. RJx-01’s multi-pathway mechanism, human Phase 1b data and the ongoing Phase 2 program position it as a differentiated therapeutic candidate with potential relevance across multiple muscle health indications. We very much look forward to the sarcopenia patient data by year end.”
Neil Greening, MD, PhD, Consultant Physician at University Hospitals of Leicester and Chief Investigator of the study, added, “Sarcopenia is a key contributor to disability and mortality in patients with COPD, driven by reduced muscle mass, strength and endurance that limits patient mobility and independence. In combination with respiratory symptoms, this loss of functional capacity accelerates overall decline, particularly during hospitalizations associated with acute exacerbations. A therapy that can reduce muscle weakness and sarcopenia in COPD patients could lead to better long-term outcomes and quality of life."
Jean-Yves Reginster, MD, PhD, Professor of Epidemiology, Public Health and Health Economics and a world-renowned expert in musculoskeletal aging and sarcopenia management, commented, “I’m excited and look forward to seeing data from this trial by the end of 2026 and continue to evaluate RJx-01’s potential. RJx-01 represents a first-in-class treatment with the potential to meaningfully address the condition and change the treatment landscape for patients.”
About the MINT-COPD Phase 2 patient trial with RJx-01
The MINT-COPD Phase 2 trial (ISRCTN14321370) is a randomized, double-blind, placebo-controlled study which, in addition to safety and tolerability, will assess RJx-01’s effects on muscle strength, physical function and muscle fatigue resistance. In a prior Phase 1b study, RJx-01 demonstrated meaningful improvements across these parameters in healthy older men with immobilization-induced muscle weakness, alongside an excellent safety and tolerability profile.
RJx-01 is designed to target multiple pathways involved in muscle decline, including mitochondrial dysfunction, inflammation, fibrosis and impairment of neuro-muscular function. Molecular analyses from preclinical studies and a previous Phase 1b trial support its potential disease-modifying mechanism of action.
The ongoing MINT-COPD Phase 2 trial is being conducted through a partnership between Rejuvenate Biomed, the University of Leicester, and the NIHR Leicester Biomedical Research Centre and is led by Dr. Neil Greening and Dr. Hamish McAuley at Leicester. It is supported by multimillion-dollar funding from Wellcome Leap’s Dynamic Resilience program, co-funded by Temasek Trust.
About Sarcopenia
Sarcopenia is characterized by the progressive loss of physical performance and skeletal muscle strength. It is a multifactorial condition that can arise in both acute and chronic settings. Acute sarcopenia is typically driven by sudden muscle disuse and immobilization, such as during hospitalization, postoperative recovery, acute exacerbations of chronic diseases (e.g., chronic obstructive pulmonary disease, COPD), or other periods of enforced inactivity. It can also occur in contexts such as obesity treatment-induced muscle loss, where rapid changes in body composition contribute to transient but clinically meaningful muscle weakness. It is a major contributor to frailty, loss of independence, and increased risk of adverse health outcomes in older adults. There are currently no treatments approved for sarcopenia despite more than 50 million people worldwide are affected with the burden expected to rise as populations age.
About Rejuvenate Biomed
Rejuvenate Biomed is a clinical-stage, AI-enabled biopharmaceutical company developing combination therapies for age-related diseases. Its lead asset, RJx-01 for sarcopenia, has shown strong safety, tolerability, and meaningful improvements in muscle strength, physical function, and fatigue resistance in a Phase 1b study. RJx-01 targets multiple drivers of muscle decline, including mitochondrial dysfunction, inflammation, fibrosis, and neuromuscular impairment. Phase 2 data in COPD-induced sarcopenia are expected by year-end 2026, while other pipeline compounds are advancing toward preclinical proof of concept. The company uses its proprietary CombinAge® AI and CelegAge® in vitro platforms to identify additional combination therapies for age-related diseases.
For more information, please visit https://www.rejuvenatebiomed.com/en.
About the NIHR Leicester Biomedical Research Centre
The National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC) is part of the NIHR and hosted by the University Hospitals of Leicester NHS Trust, in partnership with the University of Leicester, Loughborough University and the University Hospitals of Northamptonshire National Health Service Group. The NIHR Leicester BRC undertakes translational clinical research in priority areas of high disease burden and clinical need.
About Wellcome Leap
Wellcome Leap builds and executes bold, unconventional programs, funded at scale, that aim to deliver breakthroughs in human health over 5 – 10 years. Founded by the Wellcome Trust in 2020 as a US nonprofit with funding that now exceeds $1B, Leap programs target complex human health challenges with the goal of achieving breakthrough scientific and technological solutions. Operating at the intersection of life sciences and engineering, Leap programs require best-in-class, multi-disciplinary, global teams assembled from universities, companies and nonprofits working to solve problems together that they cannot solve alone.
Rejuvenate Biomed contacts
Company contact:
communications@rejuvenatebiomed.com
Media contact:
Madelin Hawtin (LifeSci Communications)
MHawtin@lifescicomms.com
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