Rejuvenate Biomed has dosed the first subject in the randomised Phase II trial to assess its lead compound, RJx-01, for treating individuals with muscle weakness and sarcopenia associated with chronic obstructive pulmonary disease (COPD).
This placebo-controlled, double-blind trial is set to assess the tolerability and safety of the combination drug in 130 older adult subjects who have been hospitalised with severe acute exacerbation of COPD.
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In addition, the trial will test the drug’s impact on muscle strength, physical function, and fatiguability.
The study is a collaborative effort between the company, the University of Leicester, UK, the National Institute for Health and Care Research Leicester Biomedical Research Centre, and Wellcome Leap.
Dr Neil Greening and Dr Hamish McCauley from the NIHR Leicester BRC at the University Hospitals of Leicester National Health Service (NHS) Trust are leading the study.
According to the company, in an earlier Phase I trial, RJx-01 showed improvements in muscle strength, fatigue resistance, and function in healthy older male subjects.
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By GlobalDataThe drug targets several cellular pathways related to muscle quality decline, including mitochondrial health and neuromuscular junction integrity.
The current research is supported by funding from the Dynamic Resilience programme, jointly funded by Temasek Trust and Wellcome Leap.
Rejuvenate Biomed CEO and founder Ann Beliën said: “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.”
Rejuvenate Biomed’s drug discovery process leverages two platforms, AI-enabled in silico CombinAge and in vivo CelegAge, leading to the development of a pipeline of five candidate combination drugs.
These candidates target various age-related diseases, including neuromuscular, metabolic, musculoskeletal, neurodegenerative, and immunology-related indications.
