Rejuvenate Biomed has announced the dosing of the first subject in its randomized Phase II clinical trial evaluating RJx-01, the company's lead compound for treating muscle weakness and sarcopenia associated with chronic obstructive pulmonary disease (COPD).
The double-blind, placebo-controlled trial will assess both the safety and tolerability of this combination drug in 130 older adult subjects who have been hospitalized with severe acute exacerbation of COPD. Beyond safety endpoints, the study will measure RJx-01's effects on muscle strength, physical function, and fatiguability.
This clinical investigation represents a collaborative effort between Rejuvenate Biomed, the University of Leicester, UK, the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre, and Wellcome Leap. Dr. Neil Greening and Dr. Hamish McCauley from the NIHR Leicester BRC at the University Hospitals of Leicester NHS Trust are leading the study.
Promising Phase I Results
According to Rejuvenate Biomed, RJx-01 has already shown encouraging results in an earlier Phase I trial, where the compound demonstrated improvements in muscle strength, fatigue resistance, and function in healthy older male subjects. The drug's mechanism of action targets several cellular pathways associated with muscle quality decline, including mitochondrial health and neuromuscular junction integrity.
The current research receives financial support from the Dynamic Resilience programme, jointly funded by Temasek Trust and Wellcome Leap.
Addressing an Unmet Medical Need
Sarcopenia, characterized by progressive loss of skeletal muscle mass and function, represents a significant but often underrecognized global health challenge, particularly in aging populations and those with chronic conditions like COPD.
Ann Beliën, CEO and founder of Rejuvenate Biomed, emphasized the significance of this trial: "Sarcopenia is an important medical condition that drives further age-related morbidity but is significantly underestimated as a global public health challenge. Currently, there are no approved treatments available."
She added, "We have received consistently positive feedback and excitement from experts in sarcopenia and public health across the world 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."
Innovative Drug Discovery Approach
Rejuvenate Biomed's drug development strategy leverages two proprietary platforms: AI-enabled in silico CombinAge and in vivo CelegAge. This approach has facilitated the development of a pipeline comprising five candidate combination drugs targeting various age-related diseases, including neuromuscular, metabolic, musculoskeletal, neurodegenerative, and immunology-related indications.
The company's focus on combination therapies represents an innovative approach to addressing complex age-related conditions where multiple cellular pathways may be involved in disease progression.
COPD and Muscle Weakness
COPD affects millions worldwide and is characterized by progressive airflow limitation and respiratory symptoms. Beyond the primary pulmonary manifestations, COPD patients frequently experience systemic effects, including skeletal muscle dysfunction and weakness, which significantly impact quality of life and functional capacity.
Muscle weakness in COPD patients is associated with reduced exercise capacity, increased healthcare utilization, and higher mortality rates. The development of therapies specifically targeting this aspect of COPD could potentially improve overall outcomes and quality of life for patients living with this chronic condition.
As the trial progresses, researchers will be closely monitoring both the safety profile and efficacy signals of RJx-01, with hopes that this compound could become the first approved treatment specifically addressing sarcopenia in COPD patients.
