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The randomized, Phase 2, double-blind, placebo-controlled clinical trial will evaluate the potential of RJx-01 to maintain muscle integrity in older persons with severe acute exacerbation of COPD
DIEPENBEEK, Belgium, May 19, 2025 (GLOBE NEWSWIRE) -- Rejuvenate Biomed, an AI-enabled, clinical-stage biotech company developing safe, synergistic combination therapeutics that alter the course of age-related diseases, announced today that the first patient has been dosed in its Phase 2 clinical trial evaluating Rejuvenate Biomed's lead investigational compound, RJx-01, in patients with chronic obstructive pulmonary disease (COPD)-related muscle weakness and sarcopenia.
The trial is the result of a partnership between Rejuvenate Biomed, the University of Leicester, the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC), and Wellcome Leap Inc. The study is led by Dr. Neil Greening and Dr. Hamish McCauley from the NIHR Leicester BRC at University Hospitals of Leicester NHS Trust.
"Following promising results from our Phase 1b study of RJx-01, which demonstrated meaningful improvements in muscle strength, function and fatigue resistance in patients with sarcopenia, we are excited to further evaluate RJx-01's potential for the treatment of muscle weakness and sarcopenia in patients with COPD”, said Ann Beliën, PhD, Founder and Chief Executive Officer of Rejuvenate Biomed. "Sarcopenia is an important medical condition that drives further age-related morbidity but is significantly underestimated as a global public health challenge. Currently there are no approved treatments available. We have received consistently positive feedback and excitement from experts in sarcopenia and public health across the world regarding RJx-01's trial and its potential to not only slow progression but restore muscle health in a way they have not seen before.”
Dr Neil Greening, Associate Professor at the University of Leicester and Chief Investigator of the study, said, "It is not widely known that many of the COPD patients with acute severe exacerbations are admitted to the hospital not only for their pulmonary problems but because their reduced overall functional capacity means they struggle at home. Patients with COPD often experience reduced muscle mass, strength and endurance, in addition to respiratory symptoms. This accelerates functional decline, especially during hospitalizations due to exacerbations. A therapy that can reduce muscle weakness and sarcopenia in COPD patients could lead to better long-term outcomes and quality of life. RJx-01 represents a first-in-class treatment that can meaningfully address sarcopenia, and we are excited to continue to evaluate its potential."
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The randomized, Phase 2, double-blind, placebo-controlled trial will evaluate the safety and tolerability of RJx-01, Rejuvenate Biomed's novel combination drug, in 130 older adults following hospitalization with severe acute exacerbation of COPD. In addition, the effects of RJx-01 on physical function, muscle strength and fatiguability will be assessed.
In a previous Phase 1b study, RJx-01 demonstrated meaningful improvements in muscle strength, function and fatigue resistance during and after immobilization-induced muscle weakness in healthy older men. RJx-01 works by targeting multiple cellular pathways involved in loss of muscle quality, including mitochondrial health, neuromuscular junction integrity, autophagy, regeneration and chronic inflammation.
This new Phase 2 clinical study is enabled by multimillion-dollar funding from the Dynamic Resilience program (co-funded by Wellcome Leap and Temasek Trust).
Rejuvenate Biomed welcomes engagement from strategic investors and partners who share the vision of transforming how we age through science and innovation.
About Rejuvenate Biomed
Rejuvenate Biomed is an AI-enabled, clinical-stage biotech company decoding the biology of aging to develop safe, synergistic combination therapeutics that holistically address the root causes of age-related diseases. Its lead Phase 2 asset, RJx-01, has already demonstrated significant potential in treating sarcopenia. By targeting multiple disease pathways simultaneously, the company aims to provide more effective treatments that can alter the course of disease. Utilizing two clinically validated proprietary drug discovery platforms, AI-enabled in silico CombinAgeTM and in vivo CelegAgeTM, Rejuvenate Biomed has generated a robust pipeline of five unique candidate combination drugs targeting different age-related diseases. These conditions range from neuromuscular, musculoskeletal, metabolic, neurodegenerative and immunology related indications. The company's disease-agnostic drug discovery platforms continue to provide insight by uncovering hidden patterns in biomedical data and translating these into future therapeutic opportunities, driving pipeline growth and potential partnerships. Rejuvenate Biomed is dedicated to promoting healthy aging. 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. Programs that aim to deliver breakthroughs in human health over 5 - 10 years. Founded by Wellcome 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
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Media contact:
Madelin Hawtin (LifeSci Communications)
