Rejuvenate Biomed reveals promising efficacy results in sarcopenia trial

Combination of metformin and galantamine demonstrates ‘meaningful improvements’ in muscle strength, function and fatigue resistance.

Longevity biotech Rejuvenate Biomed has revealed functional outcome results from the recent Phase 1b trial of its lead drug in patients with sarcopenia. The Belgian company says its lead candidate, RJx-01, a novel combination of metformin and galantamine, demonstrated positive clinical outcomes, including improvements in muscle strength, function, and fatigue resistance.

Sarcopenia, a condition affecting a substantial percentage of older adults, involves a progressive loss of muscle strength and physical performance, impacting the quality of life and increasing the risk of falls, disability, and mortality.

Following positive preclinical results, Rejuvenate Biomed commenced a randomized, double-blind, placebo-controlled study involving 42 healthy male subjects aged 65 to 75 with disuse-induced sarcopenia, and today revealed positive functional outcome results, including:

  • Improved strength: Participants showed a significant improvement in muscle strength recovery compared to the placebo group, as assessed through isometric dynamometry.
  • Improved muscle function: Participants achieved a notable improvement in leg acceleration, crucial for functional movement in daily activities.
  • Improved fatigue resistance: Participants exhibited reduced neuromuscular fatigue during leg exercises.

Rejuvenate Biomed, which previously confirmed the safety, tolerability, and bioavailability of RJx-01, now plans to commence a Phase 2 study later this year to evaluate the drug’s effects on sarcopenia and osteoporosis. The frequent coexistence of these two conditions has seen the emergence of the term “osteosarcopenia” in medical literature.

“Today marks a pivotal moment in our journey to address age-related diseases, most notably sarcopenia – a condition affecting up to one in five individuals over 65 years,” Dr Ann Beliën, CEO of Rejuvenate Biomed. “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.”

The company is also actively exploring partnership opportunities to investigate RJx-01 in combination with GLP-1 drugs, commonly used for obesity and type 2 diabetes, which have also been linked to the loss of muscle mass.

“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,” said Professor Jean-Yves Reginster, Chair of the company’s Clinical Advisory Board. “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.”

RJx-01 was discovered using Rejuvenate Biomed’s proprietary drug discovery platforms, which efficiently screen small molecules to identify promising therapeutics targeting age-related pathways. The company says it plans to make these platforms available to third parties through strategic partnerships or licensing agreements.

Photograph courtesy of Rejuvenate Biomed