- Sarcopenia – age-related loss of muscle mass and strength – affects up to 1 in 5 elderly people globally [i] but there are no approved drugs
- The newly-published data validate the predictive value of Rejuvenate Biomed's proprietary drug discovery platforms and have accelerated the advancement of RJx-01 into an ongoing 6-week placebo-controlled trial in human volunteers
DIEPENBEEK, Belgium, Aug. 9, 2023 /PRNewswire/ -- Rejuvenate Biomed NV ("Rejuvenate"), a clinical-stage company dedicated to the discovery and development of therapeutics to delay the onset of multiple age-related diseases, today announced the publication of 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 CombinAgeTM and CelegAgeTM 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.
The published data also confirm the strong predictive value of Rejuvenate's proprietary platforms, AI driven "CombinAgeTM" and in vivo C. elegans "CelegAgeTM", 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. 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".
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, CombinAgeTM and CelegAgeTM. This would not have been possible without the hard work and dedication of our talented team at Rejuvenate Biomed."
About Rejuvenate Biomed
Rejuvenate Biomed is a privately held, clinical stage, platform and pipeline company committed to the discovery and development of safe and proprietary combination drugs that delay the onset of multiple age-related diseases. Using proprietary drug discovery platforms, Rejuvenate Biomed explores synergies of well-known and safe small molecules that, when developed as unique combination drugs, have the potential to influence age-related molecular mechanisms, and thus alter the process of degenerative diseases. Rejuvenate Biomed's strategy is to rapidly build a pipeline of clinical development candidates by screening novel combinations of approved compounds. It is also working with companies to utilize its unique In Silico and In Vivo platforms that have the potential to efficiently screen small molecule libraries for modulation of a broad range of age-related pathways. To learn more about their approach, click here.