3189 Isomyosamine for the treatment of sarcopenia in older adults

Abstract Introduction Sarcopenia, a condition marked by the loss of muscle mass and function, significantly impacts older adults, contributing to frailty and decreased independence. Chronic inflammation is believed to play a key role in its progression. Isomyosamine, a small molecule derived from tobacco alkaloids, has the potential to regulate key inflammatory cytokines, including tumour necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and soluble TNF receptor 1 (sTNFR1), offering a therapeutic strategy for sarcopenia. Method In a Phase II clinical trial, older adults diagnosed with sarcopenia were administered once-daily oral doses of Isomyosamine (ranging from 600 mg to 1050 mg) for 28 days. Blood samples were collected at baseline and on Days 7, 14, 21, and 28 to measure inflammatory biomarkers. The pharmacokinetics (absorption and elimination) of the drug were also assessed. Safety and tolerability were evaluated by monitoring adverse events. Results Significant reductions in TNF-α levels were observed at both Day 7 (p = 0.04) and Day 14 (p = 0.04). IL-6 and sTNFR1 were also reduced after the first dose in most cohorts. No serious adverse events were reported, and the drug was well-tolerated. However, due to the rapid absorption and elimination of Isomyosamine, once-daily dosing may not be sufficient for therapeutic efficacy, suggesting a need for more frequent dosing in future trials. Conclusion(s) Isomyosamine shows promise as a treatment for sarcopenia, significantly reducing inflammatory biomarkers in older adults. A new Phase II clinical trial will evaluate the effects of more frequent dosing on functional recovery in patients with sarcopenia who have suffered hip or femur fractures. This study, expected to begin in Q1 2025, will assess changes in mobility and inflammatory markers to further investigate the drug’s potential in improving clinical outcomes.