Rejuvenate Biomed, a clinical-stage company advancing therapeutics to delay the onset of age-related diseases, has completed a six-week clinical proof-of-mechanism study with lead candidate RJx-01 for the treatment of sarcopenia.
Sarcopenia is a musculoskeletal disease characterised by the progressive loss of skeletal muscle strength and mass, which manifests chronically with age or as an acute condition induced by muscle disuse, for example following immobilisation due to a stay in hospital. Chronic sarcopenia affects up to 22% of 65-year-olds and 50% of 80-year-olds, with no currently approved drug treatments.
RJx-01, a novel combination drug comprising galantamine and metformin, demonstrated positive results in 42 elderly male subjects with disuse-induced muscle atrophy. In this Phase Ib trial, a randomised, double-blind, placebo-controlled study, 42 healthy men aged 65 to 75 volunteered to have one leg immobilised in a cast for two weeks, thereby inducing mild acute sarcopenia. Subsequently, they were closely monitored during the immobilisation 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 (21) received RJx-01, while the other half (21) received a placebo. Following this period, all volunteers underwent a personalised muscle strength rehabilitation programme.
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 II programme focused on RJx-01 in the treatment of sarcopenia in 2024.
Dr Silke Huettner, Chief Medical Officer of Rejuvenate Biomed, said: “This proof-of-mechanism study has confirmed the excellent pharmacokinetics, as well as the safety and tolerability profile of RJx-01. As we eagerly anticipate the forthcoming results on the exploratory endpoints, we are confident to embark on a Phase II programme dedicated to the treatment of sarcopenia in 2024. The advancement of our lead programme is paving the way for the expansion of the broader pipeline via our drug discovery platforms.”