TNF Pharmaceuticals has initiated a fully funded Phase 2b clinical trial for isomyosamine, an oral TNF-α inhibitor, targeting muscle loss (sarcopenia or frailty) in patients post hip or femur fracture surgery. This study builds on positive Phase 2a results and addresses a significant unmet need in a market with no FDA-approved oral TNF-α inhibitors, estimated at over $40 billion. The trial aims to explore isomyosamine’s efficacy in preventing inflammation-driven muscle loss after these surgeries.
This research holds considerable importance because hip and femur fracture patients, often elderly, experience rapid muscle loss and functional decline post-surgery, leading to complications, delayed recovery, and increased healthcare costs. Successfully mitigating this inflammatory response and muscle loss could substantially improve patient outcomes and potentially reduce the economic burden associated with these fractures. Furthermore, this research tackles sarcopenia, a condition affecting a substantial and growing global population with limited treatment options and high associated healthcare costs.
The Phase 2b trial, a randomized, placebo-controlled double-blind study at the University of Florida, will involve 60 patients receiving isomyosamine or a placebo for 90 days post-surgery. Researchers will track recovery time and functional improvement. Isomyosamine stands out as an oral TNF-α inhibitor, differentiating it from current injectable or infusion-based treatments. Early studies suggest it selectively targets overactive TNF-α without compromising normal immune responses to infection, and it appears to lack the serious side effects associated with traditional immunosuppressants.
Positive trial results could position isomyosamine as a first-in-class oral therapy for preventing muscle loss and frailty after hip and femur fractures, significantly impacting patient care. This could also validate isomyosamine’s broader potential in treating other inflammatory conditions and age-related diseases, solidifying its role in a growing market. Further, it may establish a new standard of care, offering a more convenient and potentially safer alternative to existing therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
