Rejuvenate Biomed NV (Rejuvenate), has published RJx-01 efficacy data in two mouse models in JCI Insight, a peer-reviewed journal dedicated to biomedical research.
The paper, titled “A combination of metformin and galantamine exhibits synergistic benefits in the treatment of sarcopenia,” has been published in collaboration with researchers at the Venetian Institute of Molecular Medicine and Padova University in Italy.
RJx-01 is a safe, orally administered and proprietary combination drug comprised of metformin and galantamine. RJx-01 was identified by Rejuvenate Biomed’s CombinAge and CelegAge drug discovery platforms and is being developed for sarcopenia and other age-related diseases.
Based on these published results, Rejuvenate has started the evaluation of RJx-01 in a 6-week placebo-controlled Phase 1b clinical trial in 42 elderly volunteers with disuse-induced muscle atrophy. Results of this clinical proof-of-mechanism trial are expected later this year.
The data published in JCI Insight demonstrate that RJx-01 significantly enhanced physical performance, muscle mass and force, neuromuscular junction stability and systemic inflammation in an Opa1-/- mouse model of sarcopenia. In addition, RJx-01 significantly improved physical performance and muscle strength in aging wildtype mice. Skeletal muscle ultrastructure, mitochondrial morphology, autophagy, lysosomal function, and satellite cell content were also significantly enhanced in this model.
Both metformin and galantamine are approved drugs that have well-established safety profiles. Metformin is commonly used to treat Type 2 diabetes while galantamine is used to treat Alzheimer’s disease. The combination of both is now, for the first time, investigated in sarcopenia.
Dr. Evi Mercken, PhD, Chief Scientific Officer of Rejuvenate Biomed, said: “Sarcopenia is an age-related muscle disease which affects millions of people worldwide, adversely impacting their functional mobility and putting them at risk of events like falls. The encouraging results of our recent work bring us a step closer to an effective pharmacological treatment for sarcopenia that would enhance quality of life, particularly among the elderly”.
The published data also confirm the strong predictive value of Rejuvenate’s proprietary platforms, AI driven “CombinAge” and in vivo C. elegans “CelegAge”, as well as the utility of both platforms for screening small molecules for modulation of age-related pathways.
Rejuvenate is using these two platforms to identify a pipeline of other drug combinations with the potential to combat age-related diseases. Rejuvenate intends to make both platforms available to third parties through partnering or licensing agreements.
Dr. Ann Beliën, PhD, Founder and Chief Executive Officer of Rejuvenate Biomed, added: “This is an exciting day for Rejuvenate Biomed. These results demonstrate the real promise of our combination drug RJx-01 as a potential option for the treatment of sarcopenia and confirm the validity of our drug discovery platforms, CombinAge and CelegAge. This would not have been possible without the hard work and dedication of our talented team at Rejuvenate Biomed.”