Leicester has welcomed the first patient onto a clinical trial evaluating whether a medicine can maintain muscle integrity in patients with acute 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.
Ann Beliën, PhD, Founder and Chief Executive Officer of Rejuvenate Biomed, said: “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.”
“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.”
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).
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