Rejuvenate Biomed Doses First Patient in Phase 2 COPD Muscle Weakness Trial of RJx-01

Rejuvenate Biomed has dosed the first patient in its Phase 2 clinical trial evaluating RJx-01, a novel combination therapeutic to treat muscle weakness and sarcopenia in chronic obstructive pulmonary disease (COPD) patients. The AI-enabled biotech targets age-related diseases by developing synergistic therapies that influence fundamental aging mechanisms. This trial focuses on older adults recovering from hospitalization due to severe COPD exacerbation.

“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 evaluate further 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, no approved treatments are available. We have received consistently positive feedback and excitement from experts in sarcopenia and public health worldwide 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.”

The study is conducted in collaboration with the University of Leicester, the NIHR Leicester Biomedical Research Centre, and Wellcome Leap Inc. It is a randomized, double-masked, placebo-controlled trial involving 130 patients, designed to assess the safety, tolerability, and efficacy of RJx-01 on outcomes such as physical function, muscle strength, and fatigue. Dr. Neil Greening and Dr. Hamish McCauley of the NIHR Leicester BRC led the trial.

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, endurance, and 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."

RJx-01 previously showed positive results in a Phase 1b study, improving muscle performance in healthy older men experiencing immobilization-induced weakness. The compound acts on several aging-related biological pathways, including mitochondrial function, neuromuscular junction integrity, and chronic inflammation. The Phase 2 trial is supported by multimillion-dollar funding from the Wellcome Leap and Temasek Trust-backed Dynamic Resilience program, and Rejuvenate Biomed is seeking strategic partners to help advance its mission.