Belgium-based Rejuvenate Biomed has dosed the first subject in the randomized Phase II trial to assess its lead compound, RJx-01, for treating patients with muscle weakness and sarcopenia associated with chronic obstructive pulmonary disease (COPD).
“Following promising results from our Phase Ib 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 CEO of Rejuvenate Biomed.
Sarcopenia is a condition characterized by loss of skeletal muscle mass and function. It primarily affects older adults. Sarcopenia is often associated with COPD, with a study estimating its prevalence to be 15-20% in stable COPD.
RJx-01 is a proprietary combination drug developed using Rejuvenate’s CombinAge and CelegAge drug discovery platforms. The company notes that it works by targeting multiple cellular pathways involved in loss of muscle quality, including mitochondrial health, neuromuscular junction integrity, autophagy, regeneration and chronic inflammation.
Phase II trial design
The placebo-controlled Phase II will evaluate the combination drug in 130 participants following hospitalization with severe acute exacerbation of COPD. In addition to safety and tolerability, the study will evaluate the effects of RJx-01 on physical function, muscle strength, and fatigue.
The trial is funded through the Dynamic Resilience program, co-funded by Wellcome Leap and Temasek Trust. It is being run in partnership with the University of Leicester (UK), the UK’s National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC), and Wellcome Leap Inc.
“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,” said Dr Neil Greening, Associate Professor at the University of Leicester and the study’s chief investigator.
“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.”
Last year, Rejuvenate reported results from a Phase Ib trial of RJx-01 for the treatment of sarcopenia. The therapy demonstrated meaningful improvements in muscle strength, function, and fatigue resistance during and after immobilization-induced muscle weakness in healthy older men.
