Rejuvenate Biomed, the University of Leicester, the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC), and Wellcome Leap Inc. have announced a partnership to conduct a Phase 2 clinical trial investigating a potential treatment for chronic obstructive pulmonary disease (COPD)-related sarcopenia. The trial will evaluate RJx-01, Rejuvenate Biomed's novel combination drug, with patient enrollment expected to begin in the first half of 2025.
The double-blind, placebo-controlled study will assess the safety and tolerability of RJx-01 in 130 older individuals following hospitalization with severe acute exacerbation of COPD. The trial will also measure the drug's effects on physical function, muscle strength, and fatiguability.
Addressing a Critical Unmet Need in COPD Management
COPD ranks as the third largest cause of mortality worldwide and is a major contributor to long-term disability. While primarily a respiratory disease, COPD has significant systemic effects, including sarcopenia—the impairment of skeletal muscle mass and function.
Patients with COPD often experience worsening physical function during hospital stays for acute exacerbations. These muscle-related complications are important predictors of mortality, morbidity, and healthcare utilization, independent of lung function impairment severity.
Dr. Neil Greening, Associate Professor at the University of Leicester, emphasized the significance of this issue: "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. Finding ways to maintain muscle function is increasingly important."
Promising Early Results for RJx-01
RJx-01 has already shown potential as an oral treatment for sarcopenia in earlier trials. In a Phase 1b study, the drug demonstrated meaningful improvements in muscle strength, function, and fatigue resistance in people with disuse-induced muscle weakness.
"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, Founder and Chief Executive Officer of Rejuvenate Biomed. "We look forward to initiating this Phase 2 study in COPD patients."
Multi-Million Dollar Support from Wellcome Leap
The clinical study is enabled by a multi-million dollar award from Wellcome Leap's Dynamic Resilience program, co-funded by Temasek Trust. This program aims to improve biological resilience in clinically vulnerable populations at risk of adverse outcomes after stressor events.
Prof. Lynne Cox, Program Director of Wellcome Leap's Dynamic Resilience program, highlighted the urgent need for such treatments: "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. We are therefore excited to support the globally excellent clinical, academic and industry teams in this study which addresses that major unmet need."
Study Leadership and Design
The Phase 2 trial will be led by Dr. Neil Greening and Dr. Hamish McCauley from the NIHR Leicester BRC at University Hospitals of Leicester NHS Trust. The study is described as a "world-first" investigation into maintaining muscle function in COPD patients experiencing acute exacerbations.
About Rejuvenate Biomed
Rejuvenate Biomed is an AI-powered, clinical-stage biotech company focused on developing safe, synergistic combination therapeutics that address the root causes of age-related diseases. The company utilizes two proprietary drug discovery platforms—the AI-enabled in silico CombinAge™ and in vivo CelegAge™—to generate treatments targeting multiple disease pathways simultaneously.
Beyond RJx-01, the company has a robust pipeline of five unique combination drugs targeting various age-related conditions, including neuromuscular, musculoskeletal, metabolic, cardiovascular, nephrological, and neurodegenerative indications.
Potential Impact on Patient Care
If successful, this trial could lead to the development of the first effective pharmaceutical intervention specifically targeting skeletal muscle dysfunction in COPD patients. Such a treatment could significantly improve recovery outcomes following hospitalization, potentially reducing mortality rates, decreasing hospital readmissions, and enhancing patients' quality of life.
The collaboration between Rejuvenate Biomed, academic institutions, and research organizations represents a comprehensive approach to addressing this complex health challenge, combining pharmaceutical innovation with clinical expertise and research funding.
