TNF Pharmaceuticals Launches Study Series to Preserve Lean Muscle Mass During GLP-1 Weight Loss Treatment
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical-stage biopharmaceutical company focused on developing innovative therapies for autoimmune and inflammatory conditions, has announced the initiation of its first clinical study in a series aimed at preserving lean muscle mass during and after GLP-1 (glucagon-like peptide-1) treatment for weight loss and chronic weight management. The study will evaluate the effects of the company’s novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preventing muscle loss associated with GLP-1 treatments, which are increasingly used for weight management in overweight and obese patients.
Addressing a Critical Challenge in Weight Loss Treatments
GLP-1 receptor agonists, including drugs like Wegovy® and Ozempic®, have become widely prescribed for weight loss, especially in patients suffering from obesity and related conditions. These medications, by mimicking the action of the GLP-1 hormone, help regulate blood sugar levels, reduce appetite, and promote weight loss. However, despite their benefits, clinical studies have shown that a significant portion of the weight lost in GLP-1-treated patients may consist of lean body mass, including skeletal muscle mass. This is a major concern, as the loss of muscle can have negative impacts on overall health, mobility, and long-term metabolic function.
Dr. Mitchell Glass, President and Chief Medical Officer of TNF Pharmaceuticals, highlighted the problem: “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.” This loss of muscle mass, known as sarcopenia, can further contribute to health complications, such as increased frailty, lower strength, and a higher risk of metabolic diseases.
Isomyosamine: Targeting Inflammation to Preserve Muscle Mass
To address this issue, TNF Pharmaceuticals is focusing on its novel drug, isomyosamine, which targets TNF-alpha (TNF-α), a cytokine involved in inflammation and immune responses. TNF-α is known to play a key role in the development and progression of sarcopenia by promoting inflammatory processes that contribute to muscle wasting. By regulating TNF-α and other pro-inflammatory cytokines, isomyosamine aims to mitigate inflammation and preserve muscle mass during GLP-1 weight loss treatments.
Dr. Glass emphasized the company’s mission: “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.” The first study in this series will specifically evaluate TNF-α levels in patients receiving GLP-1 agonists like Wegovy® or Ozempic® who show signs of increased inflammation, which is often linked to the loss of muscle mass. By addressing this inflammation, isomyosamine has the potential to enhance the effectiveness of GLP-1 weight loss therapies while preserving critical lean muscle.
Initial Study and Future Clinical Trials
The first study, which is observational in nature, will focus on identifying the role of inflammation and TNF-α in patients undergoing GLP-1 treatment. These patients will be monitored for signs of sarcopenia, and isomyosamine’s ability to regulate TNF-α levels will be evaluated. The results of this observational study will inform the design of subsequent clinical trials, which will include a broader patient population to assess isomyosamine’s efficacy in preventing muscle loss and promoting healthier weight management outcomes.
Dr. Glass explained, “Findings from the initial observational study will inform our forward move into multiple planned clinical studies designed to evaluate isomyosamine’s effects in our target population of GLP-1 patients.” TNF Pharmaceuticals is also collaborating with Renova Health, a company specializing in AI-driven healthcare solutions, to optimize patient selection and site identification for the upcoming studies. This collaboration leverages Renova’s advanced AI and machine learning technologies to ensure the efficient selection of patient cohorts and study sites, facilitating a faster and more precise evaluation process.
David Jacobs, CEO of Renova Health, expressed enthusiasm about the partnership: “We are proud to partner with TNF to tackle the critical challenges faced by patients using GLP-1 medications. 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.”
TNF Pharmaceuticals TNF Pharmaceuticals
The Growing Market for GLP-1 Medications
The market for GLP-1 receptor agonists is rapidly expanding. Valued at $49.3 billion in 2024, it is projected to reach $105 billion by 2029, growing at a compound annual growth rate (CAGR) of 19.2%. The increasing prevalence of obesity and related metabolic diseases, alongside the proven efficacy of GLP-1 medications in managing these conditions, is driving this growth. According to the Centers for Disease Control and Prevention (CDC), obesity alone costs the U.S. healthcare system nearly $173 billion annually, making it a critical public health issue that necessitates effective treatment options.
Given this market growth, the importance of preserving lean muscle mass during weight loss treatments becomes even more significant. By ensuring that weight loss does not come at the expense of muscle mass, TNF Pharmaceuticals’ isomyosamine could help improve patient outcomes and provide a safer, more sustainable approach to chronic weight management.
Isomyosamine: A Promising Solution for Inflammation-Driven Diseases
Isomyosamine is a novel plant-derived alkaloid that regulates the immune system by modulating several pro-inflammatory cytokines, including TNF-alpha. By inhibiting TNF-α, which is responsible for initiating and maintaining inflammation, isomyosamine has the potential to treat a variety of age-related diseases and disorders driven by chronic inflammation. Research has shown that TNF-α plays a central role in the pathogenesis of numerous inflammatory conditions, including sarcopenia, autoimmune diseases, and other metabolic disorders.
TNF Pharmaceuticals is focusing on expanding isomyosamine’s clinical applications to address diseases associated with inflammation, offering a new avenue for treatment and improving patients’ quality of life. In addition to sarcopenia, the drug is being developed for a range of conditions marked by chronic inflammation, further establishing its potential in the biopharmaceutical space.
About TNF Pharmaceuticals, Inc.
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) is a clinical-stage pharmaceutical company focused on developing two promising drug platforms aimed at treating the root causes of disease rather than merely alleviating symptoms. The company’s isomyosamine platform addresses chronic inflammation, while its second platform, Supera-CBD, targets chronic pain, addiction, and epilepsy. Supera-CBD is a synthetic derivative of cannabidiol (CBD), and it aims to improve upon existing CBD therapies, including both FDA-approved drugs and non-regulated CBD products. For more information about TNF Pharmaceuticals, visit www.tnfpharma.com.
