TNF Pharmaceuticals Inc (Nasdaq: TNFA), a clinical stage biopharmaceutical company developing novel oral therapies for autoimmune and inflammatory conditions, on Wednesday announced positive clinical data supporting the expansion of its Phase 2b study for isomyosamine, its novel TNF-alpha (TNF-α) inhibitor drug, into multiple indications.

The company has successfully completed an FDA-recommended safety study, which showed favorable results over 13 weeks at all dose levels.

TNFA plans to initiate a Phase 2b clinical trial in early 2025 to assess the efficacy of isomyosamine in treating sarcopenia, a market expected to reach USD4.02bn by 2029. Additionally, the company will launch a study to evaluate isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty in patients using GLP-1 agonists like Wegovy or Ozempic, targeting a rapidly growing USD105bn market by 2029.

Isomyosamine, a novel small molecule, modulates inflammatory cytokines including TNF-α, which plays a key role in aging and various age-related diseases. The TNF inhibitor market alone is projected to reach USD47.3bn by 2029.