TNF Pharmaceuticals has achieved a key safety data milestone supporting expanded and longer-term clinical studies of its novel TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in multiple indications.
The company successfully completed an FDA-recommended study of isomyosamine that demonstrated clinical safety throughout 13 weeks of treatment at all dose levels evaluated.
“Positive data from this milestone study confirms isomyosamine’s historically strong safety profile and enables us to extend the duration of future clinical trials. We believe we are fully equipped to advance our comprehensive isomyosamine platform in a longer-term clinical trial in sarcopenia and future studies in multiple conditions associated with immunometabolic dysregulation,” said Mitchell Glass, MD, President and Chief Medical Officer of TNFA.
Sarcopenia/frailty: TNFA plans to launch a Phase 2b clinical trial of isomyosamine’s efficacy in sarcopenia early in the first quarter of 2025. The study will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier Phase 2 clinical study.
The sarcopenia treatment market is estimated to be USD 3.07 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 4.48 percent and is estimated to reach USD 4.02 billion by 2029.
GLP-1 muscle loss: the company recently announced a planned trial of isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty. The fully funded study is expected to evaluate TNF-α levels in patients receiving GLP-1 agonist Wegovy or Ozempic who show signals for increased inflammation associated with sarcopenia. Currently valued at USD 49.3 billion, the GLP-1 agonist market is projected to reach UUSD 105 billion by 2029, growing at an expected CAGR of 19.2 percent from 2023 to 2029.2 According to the Centers for Disease Control and Prevention, obesity costs the US healthcare system nearly USD 173 billion annually.
TNF inhibitor drug category: the global market value for TNF inhibitors was estimated to be USD 39.7 billion in 2024. Growing at an expected CAGR of 3.6 percent for the next five years, the TNF inhibitor market is expected to reach USD 47.3 billion by 2029.
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