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 that they have entered into an agreement to execute a Phase 2 clinical trial in patients with chronic obstructive pulmonary disease (COPD)-related sarcopenia.
COPD is the third largest cause of mortality worldwide1, and one of the major long-term conditions leading to disability. While COPD is primarily a lung disease, it has significant systemic effects that extend beyond the respiratory system, including impaired skeletal muscle mass and function, also referred to as sarcopenia.
Often, people living with COPD end up in hospital with a flare-up of their condition, where there is further worsening of their physical function. These systemic manifestations of sarcopenia for which therapeutic interventions are lacking, are important predictors of mortality, morbidity and healthcare utilization independent of the severity of lung function impairment.
As such, there is a strong rationale for the development of pharmaceutical agents that target skeletal muscle dysfunction in patients with COPD to improve overall patient outcomes.
In a Phase 1b trial, Rejuvenate Biomed’s novel combination drug RJx-01 demonstrated great potential as an oral treatment for sarcopenia, showing meaningful improvements in muscle strength, function, and fatigue resistance in people with disuse-induced muscle weakness.
The new study, a double-blind placebo-controlled trial, will evaluate the safety and tolerability of RJx-01 in 130 older individuals following hospitalization with severe acute exacerbation of COPD. In addition, the effects of RJx-01 on physical function, muscle strength and fatiguability will be assessed.
The clinical study is enabled by a multimillion dollar award from Wellcome Leap’s Dynamic Resilience program (co-funded by Temasek Trust).
The Dynamic Resilience program aims to improve biological resilience in clinically vulnerable people at-risk of adverse outcomes after a stressor event, by identifying resilience biomarkers and mechanisms and facilitating proof-of-concept studies and clinical trials of potential preventative interventions.
This study will be led by Dr Neil Greening and Dr Hamish McCauley from the NIHR Leicester BRC at University Hospitals of Leicester NHS Trust.
“We are grateful for the support of NIHR Leicester BRC and Wellcome Leap as we explore the potential of RJx-01 as a treatment for patients living with COPD suffering from muscle weakness,” said Dr. Ann Beliën, Founder and Chief Executive Officer of Rejuvenate Biomed.
“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. We look forward to initiating this Phase 2 study in COPD patients.“
Dr Neil Greening, Associate Professor at the University of Leicester said “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. Findings ways to maintain muscle function is increasingly important, which is why we’re delighted to be working with Rejuvenate Biomed and on this world-first study, enabled by Wellcome Leap.”
Prof Lynne Cox, Program Director of Wellcome Leap’s Dynamic Resilience program added: “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.”
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- Institute for Health Metrics and Evaluation. Global Burden of Disease Study 2019 (GBD 2019) results. Seattle, WA: Institute for Health Metrics and Evaluation, 2019