TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) is advancing its novel TNF-alpha (TNF-α) inhibitor drug, isomyosamine, for sarcopenia and muscle loss associated with GLP-1 therapies. The company has achieved a key safety milestone and is planning a Phase 2b clinical trial for sarcopenia, as well as studies focused on preserving lean muscle mass during GLP-1 treatment.
Isomyosamine Demonstrates Safety, Enabling Expanded Clinical Studies
TNF Pharmaceuticals successfully completed an FDA-recommended study of isomyosamine, demonstrating clinical safety throughout 13 weeks of treatment at all dose levels evaluated. This positive data supports the expansion of clinical studies to longer durations and multiple indications.
"Positive data from this milestone study confirms isomyosamine’s historically strong safety profile and enables us to extend the duration of future clinical trials," said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. "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."
Phase 2b Trial Planned for Sarcopenia/Frailty
TNFA plans to launch a Phase 2b clinical trial of isomyosamine’s efficacy in sarcopenia early in the first quarter of 2025. This trial will further explore the drug’s efficacy in sarcopenia/frailty, building on statistically significant positive results from an earlier Phase 2 clinical study. The sarcopenia treatment market is estimated to reach $4.02 billion by 2029, growing at a CAGR of 4.48% from $3.07 billion in 2024.
Addressing GLP-1-Induced Muscle Loss
TNF Pharmaceuticals is also addressing the issue of muscle loss associated with GLP-1 receptor agonists like Wegovy and Ozempic. Studies have shown that up to 40% of total weight loss in GLP-1 patients is lean body mass, including skeletal muscle mass. The company has initiated a study series to evaluate the impact of isomyosamine in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management.
The first study examines TNF-α levels in patients receiving GLP-1 agonists who show signs of increased inflammation associated with sarcopenia. Isomyosamine targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia.
"The body of evidence for the GLP-1 drug class shows that up to 40% of total weight loss in GLP-1 patients is lean body mass including skeletal muscle mass," said Dr. Glass. "The purpose of our clinical study series is to assess isomyosamine’s potential to preserve lean muscle mass during and following GLP-1 weight loss in chronic overweight and obese patients of all age groups."
Collaboration with Renova Health
TNF Pharmaceuticals is collaborating with Renova Health, leveraging their AI and machine learning technology to analyze and identify optimal patient pools and study sites. This collaboration aims to enable efficient progression of the study series.
"We are proud to partner with TNF to tackle the critical challenges faced by patients using GLP-1 medications," said David Jacobs, Chief Executive Officer of Renova Health. "This collaboration is expected to allow us to leverage our advanced AI and machine learning capabilities for precise cohort selection and patient engagement, enabling us to uncover deeper, more meaningful patient insights that will enhance the study’s impact."
Market Opportunity
The GLP-1 receptor agonist market is currently valued at $49.3 billion and is projected to reach $105 billion by 2029, growing at a CAGR of 19.2% from 2023 to 2029. The TNF inhibitor market is also substantial, estimated at $39.7 billion in 2024 and expected to reach $47.3 billion by 2029, growing at a CAGR of 3.6%.
TNF Pharmaceuticals aims to address the unmet need for therapies that can preserve muscle mass during weight loss, particularly in the context of GLP-1 treatment, with isomyosamine potentially becoming a first-in-class therapy for this growing population.
