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TNF Pharmaceuticals (NASDAQ: TNFA) has initiated a Phase 2b clinical trial for isomyosamine, their oral TNF-alpha inhibitor drug candidate, targeting chronic inflammation associated with muscle loss in post-surgical hip/femur fracture patients.
The fully funded, randomized, placebo-controlled study at the University of Florida will evaluate 60 patients for up to 90 days post-surgery. The trial builds on previous positive Phase 2a results and aims to explore isomyosamine's efficacy in preventing progressive muscle loss and frailty.
Key advantages of isomyosamine include:
- Oral administration versus current injection/infusion-only options
- Selective TNF-α blocking where overactivated
- Ability to cross blood-brain barrier
- Lower risk of serious side effects compared to traditional treatments
The target market is substantial:
- TNF-alpha inhibitor market: $39.7B (2024), expected to reach $47.3B by 2029
- Sarcopenia affects 10-16% of elderly population
- Sarcopenia treatment market: $3.07B (2024), projected to reach $4.0B by 2029
TNF Pharmaceuticals (NASDAQ: TNFA) has initiated a series of studies to evaluate its oral TNF-alpha inhibitor drug, isomyosamine, for preserving lean muscle mass during GLP-1 weight loss treatment. The studies focus on patients taking Wegovy® or Ozempic®, as up to 40% of total weight loss from GLP-1 treatments comes from lean body mass.
The first study will examine TNF-α levels in GLP-1 patients showing increased inflammation associated with sarcopenia (progressive muscle mass loss). TNF is collaborating with Renova Health, which will utilize its AI and machine learning technology to analyze and identify optimal patient pools and study sites.
The initiative targets the rapidly growing GLP-1 market, valued at $49.3 billion in 2024 and projected to reach $105 billion by 2029, with a CAGR of 19.2% from 2023-2029.
TNF Pharmaceuticals (NASDAQ: TNFA) has partnered with Renova Health to study isomyosamine (MYMD-1) as a treatment for GLP-1-induced sarcopenia and frailty. The fully funded trial will evaluate TNF-α levels in patients using Wegovy or Ozempic who show inflammation associated with sarcopenia.
Studies indicate up to 40% of GLP-1-related weight loss comes from lean body mass, including muscle. If successful, isomyosamine could become a first-in-class therapy for preserving muscle mass during GLP-1 weight loss. The GLP-1 market is valued at $49.3 billion in 2024 and projected to reach $105 billion by 2029.
TNFA is currently conducting a Phase 2 trial for aging-related sarcopenia and plans to launch a Phase 2b study in Q1 2025 following positive Phase 2a results.
TNF Pharmaceuticals (NASDAQ: TNFA) announced significant positive topline results from a Phase 2a study of MYMD-1® (isomyosamine) for sarcopenia treatment. The double-blind, placebo-controlled study in patients aged 65+ showed significant decreases in inflammatory biomarkers, including TNF-α (P=0.008), IL-6 (P=0.03), and sTNFR1 (P=0.02), with no serious adverse events reported.
Based on these results, the company plans to initiate a Phase 2b study in early 2025. The global TNF inhibitor market is valued at $39.7 billion in 2024, expected to reach $47.3 billion by 2029. The sarcopenia treatment market, currently at $3.07 billion, is projected to grow to $4.02 billion by 2029, with over 50 million people affected globally.
TNF Pharmaceuticals (Nasdaq: TNFA) is advancing its lead program, MYMD-1®, through fully funded mid-stage clinical trials. MYMD-1 is a small molecule that blocks excessive TNF-alpha activity to regulate the immuno-metabolic system. The company's next clinical studies will focus on sarcopenia/frailty following statistically significant results from a Phase 2 study.
MYMD-1 met primary endpoints in reducing chronic inflammatory markers with statistical significance in sarcopenia/frailty. The company also holds FDA-cleared Phase 2 INDs for MYMD-1 in rheumatoid arthritis and Hashimoto's thyroiditis. TNFA is preparing to reveal its next steps towards value creation and long-term growth.
TNF Pharmaceuticals, formerly MyMD Pharmaceuticals, has begun trading under its new Nasdaq stock symbol TNFA as of July 24, 2024. This change reflects the company's focus on inhibiting TNF-alpha to regulate the immuno-metabolic system. The company's lead clinical candidate, MYMD-1, blocks excess TNF-α activity, potentially restoring immune system control and regulation.
Dr. Mitchell Glass, President and Chief Medical Officer, emphasized that this rebranding aligns with their core science and highlights MYMD-1's potential as the first TNF-α inhibitor in its indication. The company's CUSIP remains unchanged, and current stockholders need not take any action regarding the symbol change.
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