Clinical study to explore potential of metformin and galantamine combination to address sarcopenia in patients with COPD.
Longevity biotech Rejuvenate Biomed has announced plans to conduct a Phase 2 clinical trial for its experimental drug RJx-01 as a potential treatment for sarcopenia, an age-related condition involving loss of muscle mass and strength. The trial, scheduled to begin patient enrollment in early 2025, will assess the drug’s potential to address sarcopenia in patients with chronic obstructive pulmonary disease (COPD).
COPD, the third leading cause of death worldwide, is a progressive condition marked by respiratory complications. However, its effects extend beyond the lungs, and one of its most debilitating complications is sarcopenia, which affects nearly a quarter of COPD patients. Sarcopenia is particularly pronounced in patients hospitalized for COPD, with hospital stays often resulting in further loss of muscle mass and functional decline. This muscle weakness contributes to higher mortality and morbidity rates, increased disability and mounting healthcare costs.
RJx-01, a combination of metformin and galantamine, is one of five combination drugs in Rejuvenate Biomed’s development pipeline. Through its AI-driven drug discovery platforms, the company identifies and targets disease pathways associated with age-related conditions, including neuromuscular, musculoskeletal, metabolic, cardiovascular, nephrological and neurodegenerative diseases.
The new Phase 2 study will examine the efficacy and safety of RJx-01 in 130 older patients who have experienced a severe COPD exacerbation. The study builds on promising data from Rejuvenate Biomed’s Phase 1b trial, in which RJx-01 showed improvements in muscle strength, functional mobility and fatigue resistance among individuals with sarcopenia. The trial, involving 42 participants aged 65 to 75, revealed significant gains in muscle strength, along with improved functional leg acceleration and resistance to neuromuscular fatigue during exercise.
“Positive results from our recent Phase 1b study underscore RJx-01’s potential to prevent and treat sarcopenia induced by other conditions, and improve patients’ quality of life,” said Dr Ann Beliën, CEO of Rejuvenate Biomed. “We look forward to initiating this Phase 2 study in COPD patients.”
‘Urgent need’ for treatments
The funding for the Phase 2 trial is supported by a “multimillion dollar” award from Wellcome Leap’s Dynamic Resilience program, which focuses on developing interventions to enhance biological resilience in clinically vulnerable individuals, especially those at risk of significant decline after a major health event.
“We urgently need treatments that can help prevent muscle wastage and frailty progression when people are hospitalized with acute illness, to enable them to return home and live safely and independently,” said Professor Lynne Cox, program director of Wellcome Leap’s Dynamic Resilience program.
Belgium-based Rejuvenate Biomed is partnering with the UK’s Leicester Biomedical Research Centre (BRC) and US-based Wellcome Leap on the trial, which seeks to improve physical resilience and long-term outcomes for COPD patients. The trial at the Leicester BRC will be led by Dr Neil Greening and Dr Hamish McCauley from the University Hospitals of Leicester NHS Trust.
“Muscle wastage is a significant burden for many of our COPD patients and it can impact on their ability to recover, particularly when they are in hospital and experiencing exacerbations,” said Greening.
