There are currently no approved drug treatments for sarcopenia despite it affecting up to half of people aged over 80 years.
A 6-week clinical proof-of-mechanism study examining RJx-01, a novel combination drug comprising galantamine and metformin, has demonstrated positive results among 42 elderly subjects.
The drug is developed by Beligium-based firm, Rejuvenate Biomed, a clinical-stage company seeking to advancce therapeutics that delay the onset of age-related diseases.
In this successful Phase 1b trial, RJx-01 met all primary and secondary endpoints. RJx-01 was deemed generally safe and well tolerated with no reported serious or severe adverse events related to the treatment. The trial also reported “excellent bioavailability”.
Results evaluating the impact of RJx-01 on exploratory pharmacodynamic parameters, including blood and muscle-related biomarkers, along with clinical assessments of muscle mass and strength, are anticipated later this year. Rejuvenate Biomed is gearing up to initiate a Phase 2 programme focused on RJx-01 in the treatment of sarcopenia in 2024.
“This proof-of-mechanism study has confirmed the excellent pharmacokinetics, as well as the safety and tolerability profile of RJx-01,” said Dr. Silke Huettner, chief medical officer of Rejuvenate Biomed.
“As we eagerly anticipate the forthcoming results on the exploratory endpoints, we are confident to embark on a Phase 2 program dedicated to the treatment of sarcopenia in 2024. The advancement of our lead program is paving the way for the expansion of the broader pipeline via our drug discovery platforms.”
Sarcopenia is a musculoskeletal disease characterised by the progressive loss of skeletal muscle strength and mass. It poses a significant health challenge, especially to older adults.
The disease manifests chronically with age or as an acute condition induced by muscle disuse, for example following immobilization due to a stay in hospital. Chronic sarcopenia affects up to 22 per cent of 65-year-olds and 50 per cent of 80-year-olds. There are no currently approved drug treatments.
As part of the randomised, double-blind, placebo-controlled study, 42 healthy men aged 65 to 75 volunteered to have one leg immobilized in a cast for two weeks, thereby inducing mild acute sarcopenia.
Subsequently, they were closely monitored during the immobilization phase and for an additional four weeks post-cast removal in the recovery phase. Throughout the entire six-week treatment duration, half of the participants received RJx-01, while the other half received a placebo. Following this period, all volunteers underwent a personalised muscle strength rehabilitation program.
This significant clinical trial builds on preclinical proof-of-concept data generated from two mouse models. These promising results were recently published in JCI Insight, titled “A combination of metformin and galantamine exhibits synergistic benefits in the treatment of sarcopenia“.
Rejuvenate Biomed has developed two proprietary drug discovery platforms, in silico CombinAge and in vivo CelegAge, to screen molecule libraries across a wide spectrum of age-related pathways. These molecules are developed into unique combination drugs with the potential to influence the underlying molecular mechanisms of ageing.