3142 Development of tools and criteria to select and prioritise candidate interventions for early-phase sarcopenia clinical trials

Abstract Background Recent advances in skeletal muscle biology have identified multiple potential candidate therapeutic interventions for sarcopenia. A systematic approach is needed to prioritise the most promising interventions for early-phase clinical studies. Methods A multidisciplinary team with expertise in sarcopenia, early-phase clinical trials, and geriatric medicine sought to identify target product profile (TPP) and intervention selection tools for neuromuscular conditions. As none were identified for sarcopenia, the group then developed a sarcopenia TPP. An algorithm was created to select interventions most suitable for early-phase trials, combining ‘stop/go’ criteria and traffic-light ratings. The tool was tested by evaluating outputs from a recent horizon scan and was adapted iteratively based on the findings. Results Key characteristics of an effective intervention for sarcopenia, as outlined by the Therapeutic Product Profile (TPP), include: The selection algorithm starts with two questions: ‘Is the drug contraindicated for older adults?’ and ‘Is there already a Phase 2/3 clinical trial evaluating this or similar agents for sarcopenia?’ The assessment considers evidence strength, mechanism of action, effective dose, safety in older adults, administration route and frequency, side effects, patent status, and availability. Examples of interventions include Alverine citrate (deprioritised as it is contraindicated in older adults), melatonin (prioritised for its safety and plausible mechanism), and angiotensin-receptor blockers (deprioritised due to previous Phase II testing). Conclusions The TPP and intervention selection tool show promise in enabling systematic evaluation of candidate sarcopenia interventions. They will now be used to select and prioritise interventions for future trials.