Rejuvenate Biomed, NIHR Leicester BRC, and Wellcome Leap Collaborate for Phase 2 COPD-Sarcopenia Study

Rejuvenate Biomed, in collaboration with the University of Leicester, the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC), and Wellcome Leap Inc., has announced the initiation of a Phase 2 clinical trial targeting sarcopenia in patients with chronic obstructive pulmonary disease (COPD). This trial is set to begin patient enrollment in the first half of 2025.

COPD remains a significant global health concern, ranking as the third leading cause of death worldwide. While primarily a respiratory condition, COPD also has notable systemic effects, including the deterioration of skeletal muscle mass and function, known as sarcopenia. This muscle degradation is exacerbated during acute exacerbations of COPD, often leading to hospitalizations and further physical decline. The systemic effects of sarcopenia are critical determinants of patient outcomes, influencing mortality, morbidity, and healthcare resource use, independent of the severity of respiratory impairment. This underscores the need for therapeutic strategies specifically targeting muscle dysfunction in COPD patients to enhance their overall health outcomes.

In a previous Phase 1b trial, Rejuvenate Biomed's novel combination drug, RJx-01, showed promising results as an oral treatment for sarcopenia. Participants exhibited significant improvements in muscle strength, function, and resistance to fatigue in conditions of disuse-induced muscle weakness.

The upcoming Phase 2 trial will be a double-blind, placebo-controlled study involving 130 elderly individuals who have been hospitalized due to severe acute exacerbations of COPD. The primary objectives will be to assess the safety and tolerability of RJx-01. Additionally, the trial will evaluate the drug's impact on physical function, muscle strength, and fatigue levels.

This clinical study is supported by a multimillion-dollar grant from Wellcome Leap's Dynamic Resilience program, which is co-funded by Temasek Trust. The Dynamic Resilience program focuses on enhancing biological resilience in clinically vulnerable populations by identifying resilience biomarkers and mechanisms, and by facilitating proof-of-concept studies and clinical trials for potential preventative treatments. Dr. Neil Greening and Dr. Hamish McCauley from the NIHR Leicester BRC at University Hospitals of Leicester NHS Trust will lead the study.

“We are grateful for the support provided by NIHR Leicester BRC and Wellcome Leap as we investigate RJx-01’s potential to treat muscle weakness in COPD patients,” said Dr. Ann Beliën, Founder and CEO of Rejuvenate Biomed. She emphasized that the positive outcomes from their Phase 1b study highlight RJx-01’s promise in preventing and treating sarcopenia caused by various conditions, thereby improving patients' quality of life. She looks forward to beginning this Phase 2 study in COPD patients.

Dr. Neil Greening from the University of Leicester remarked on the significant challenge that muscle wastage poses for COPD patients, particularly during hospital stays due to exacerbations. He noted the importance of finding methods to preserve muscle function and expressed his enthusiasm for the collaboration with Rejuvenate Biomed on this pioneering study, enabled by Wellcome Leap.

Prof. Lynne Cox, Program Director of Wellcome Leap’s Dynamic Resilience program, highlighted the urgent need for treatments that can prevent muscle wastage and the progression of frailty during hospitalizations for acute illnesses. She expressed excitement about supporting the exceptional clinical, academic, and industry teams involved in this study, which addresses a major unmet medical need.

Rejuvenate Biomed is a clinical-stage biotech company focused on developing combination therapies to combat age-related diseases by targeting multiple disease pathways. Their lead asset, RJx-01, has shown potential in treating sarcopenia, and the company continues to advance its pipeline of combination drugs using its proprietary drug discovery platforms. The NIHR Leicester BRC, part of the NIHR and hosted by the University Hospitals of Leicester NHS Trust, conducts translational research in high-priority areas. Wellcome Leap, founded in 2020, aims to deliver breakthroughs in human health through bold, interdisciplinary programs.