TNF Pharmaceuticals Initiates Phase 2b Clinical Trial of First Oral TNF-Alpha Inhibitor

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage biopharmaceutical company committed to developing novel oral therapies for autoimmune and inflammatory conditions, has initiated a Phase 2b clinical trial of its lead drug candidate, isomyosamine (MYMD-1), as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery. This marks an important milestone in the company's mission to develop a novel science for immuno-metabolic regulation and increased longevity.

The Phase 2b trial is a randomized, placebo-controlled, double-blind study involving 60 patients who will be treated with isomyosamine or placebo for up to 90 days after surgery. The study aims to measure the extent and time course of recovery, comparing active dosing to placebo, to evaluate functional improvement. The primary endpoint is the change in muscle mass and strength from baseline to day 90, as assessed by dual-energy X-ray absorptiometry (DXA) and isokinetic dynamometry, respectively.

The initiation of this trial comes on the heels of positive results achieved in an earlier Phase 2a trial, which demonstrated the safety and efficacy of isomyosamine in reducing inflammation and preserving muscle mass in patients with sarcopenia. The global market value for TNF inhibitors was estimated to be $39.7 billion in 2024, with an expected CAGR of 3.6% for the next five years, reaching $47.3 billion by 2029. The introduction of an oral TNF-alpha inhibitor like isomyosamine has the potential to significantly impact this market by offering a more convenient, cost-effective, and potentially safer treatment option for patients.

The Phase 2b trial is being conducted at the University of Florida, in collaboration with Renova Health, a leading innovator supporting superior healthcare outcomes. The study aims to further explore the efficacy of isomyosamine in preventing progressive muscle loss and frailty in patients undergoing hip or femur fracture repair surgery. The results of this trial will provide valuable insights into the potential of isomyosamine as a treatment for chronic inflammation associated with muscle loss and frailty, and could open up a new market for the drug, contributing to the estimated $40+ billion TNF inhibitor market.

In conclusion, the initiation of the Phase 2b clinical trial of isomyosamine represents a significant step forward in the development of a novel oral TNF-alpha inhibitor for the treatment of chronic inflammation associated with muscle loss. With a growing market for TNF inhibitors and the potential for an oral treatment option to offer improved patient convenience and adherence, the success of this trial could have a substantial impact on the market and on the lives of patients affected by sarcopenia and frailty.