This news is especially interesting to our typical forum members because this is a combination of two generic drugs that are easily available today, inexpensively. So, people can try this themselves and report back on results. See details in the discussion thread of this post.
Rejuvenate Biomed’s clinical trial demonstrates the therapeutic potential of RJx-01 in sarcopenia
Cutting-edge therapy shows meaningful improvements in muscle strength, function and fatigue resistance, offering hope for millions suffering from sarcopenia
Diepenbeek, Belgium, February 21st, 2024 – Rejuvenate Biomed NV (“Rejuvenate Biomed"), a pioneering clinical-stage platform and pipeline company committed to enhancing lifelong health through innovative therapeutics, today announces breakthrough functional outcome results from its Phase 1b trial of lead candidate RJx-01 for the treatment of sarcopenia.
Sarcopenia, a condition affecting up to 22% of 65-year-olds and 50% of 80-year-olds, is characterized by the progressive loss of muscle strength and physical performance. This decline not only impacts the quality of life but also elevates the risk of falls, disability, and mortality, particularly among the older population.
RJx-01 is a proprietary combination drug [consisting of metformin and galantamine] that was identified by the Company’s in-house drug discovery platform and has shown to have beneficial effects on various preclinical models of sarcopenia [1]. The recent exploratory clinical trial results, which follow earlier confirmation of safety, tolerability, and pharmacokinetics [2], highlight the potential of RJx-01 in addressing the unmet need for effective sarcopenia treatments.
A first test with 42 healthy volunteers - between 65 and 75 years old - yielded ‘ fantastic ’ results. The participants received a cast around one leg for two weeks. Due to the immobilization they lost muscle strength. Everyone then received a training program. In the participants who received the drug - in the form of spheres - the quadriceps and hamstrings recovered significantly faster. The other participants received a placebo. There was also a statistically significantly better score in terms of muscle fatigue (after longer efforts) and muscle responsiveness (as an indicator of stability).
The results are a first win for Rejuvenate Biomed. ‘ The study with patients continues. That’s a no-brainer. If our treatment stabilizes the disease, that’s quite a lot. That allows for early intervention. But of course we hope for an improvement ’, says Rejuvenate CEO and Founder Ann Beliën.
Sarcopenia has a detrimental impact on the quality of life of the elderly. ‘ I saw it with my father. It starts with walking with a stick, then a walker, then a wheelchair. Having less muscle means no longer being able to open a bottle cap, walking less long distances, struggling to shop for groceries, visiting the grandchildren. It’s about those things. We do not want to run the elderly a marathon, but let them return to normal social life, let them age with mobility. ’
The key findings of the Phase 1b trial with RJx-01 reveal promising functional outcomes:
- Improved strength: Participants with disuse-induced sarcopenia treated with RJx-01 exhibited a promising improvement in muscle strength recovery compared to the placebo group. This beneficial effect, assessed through isometric dynamometry, underscores the ability of RJx-01 to promote muscle strength improvement, an outcome that would support the daily activities of sarcopenia patients.
- Improved muscle function: Treatment with RJx-01 led to an important improvement of leg acceleration, assessed through isokinetic dynamometry. The ability to accelerate the limb rapidly is important for functional movement in daily activities and is pivotal in mitigating fall risks – a critical consideration for sarcopenia patients.
- Improved fatigue resistance: Neuromuscular fatigue was assessed by monitoring muscle parameters during a series of leg exercises. Participants receiving RJx-01 showed a reduced propensity for fatigue indicating that RJx-01 can promote physical activities such as walking, a performance improvement that is important for sarcopenia patients.
Dr. Ann Beliën, Founder and Chief Executive Officer of Rejuvenate Biomed, expressed her enthusiasm, stating: “Today marks a pivotal moment in our journey to address age-related diseases, most notably sarcopenia – a condition affecting up to 1 in 5 individuals over 65 years. The impact demonstrated by RJx-01 offers great potential to make a substantial difference for individuals with sarcopenia or muscle strength loss due to other underlying factors. We eagerly anticipate advancing our Phase 2 program later this year, aiming to substantiate RJx-01’s therapeutic potential in addressing sarcopenia and osteoporosis.”
Prof. Dr. Jean-Yves Reginster, Chair of Rejuvenate Biomed’s Clinical Advisory Board, added: “These compelling data confirm RJx-01’s promise to improve physical performance and muscle strength. With aging populations, it is inevitable that the number of people living with long-term health conditions will rise, challenging one’s functional abilities and overall physical performance. Thus, it is crucial that companies like Rejuvenate Biomed work towards the goal of treating and even preventing the development of age-related diseases such as sarcopenia.”
Prof. Dr. Roger Fielding, Clinical Advisory Board member of Rejuvenate Biomed, echoed his resounding endorsement: “The number of people living with muscle-related conditions is increasing, emphasizing the urgent need for viable solutions to improve the age-related decline in muscle performance. The new data announced today by Rejuvenate Biomed regarding RJx-01 are very promising for patients with sarcopenia, as well as for those experiencing a loss of muscle function due to other causes.”
Rejuvenate Biomed will commence a Phase 2 study evaluating RJx-01’s effect on sarcopenia and osteoporosis, as these two diseases often co-exist, so frequently that ‘osteosarcopenia’ has recently been described in medical literature as a distinct syndrome. Additionally, the Company is actively exploring partnership opportunities to investigate RJx-01 in combination with GLP-1 drugs, that are marketed for obesity and diabetes type 2.
The positive outcomes from the Phase 1b trial validate the predictive power of Rejuvenate Biomed’s proprietary drug discovery platforms CombinAgeTM and CelegAgeTM, which efficiently screen small molecules to identify promising therapeutics targeting age-related pathways. Rejuvenate Biomed intends to make these platforms available to third parties through strategic partnerships or licensing agreements.
- Tezze C, et al. JCI Insight 2023; 8(15):e168787. https://doi.org/10.1172/jci.insight.168787
- Rejuvenate Biomed - Positive results Phase 1b trial in sarcopenia
Related
(Galantamine + metformin) overview
The combination drug metformin and galantamine (RJx-01) is under development for the treatment of sarcopenia, disuse-induced muscle atrophy and unspecified indication. The drug candidate is a small molecule combination product. It is administered through oral route. It is being developed based on artificial intelligence driven technology platform.
