TNF Pharmaceuticals Launches Study Series Aimed at Preserving Lean Muscle Mass During GLP-1 Weight Loss Treatment
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) ha avviato una serie di studi per valutare il suo farmaco inibitore della TNF-alfa orale, isomyosamine, per preservare la massa muscolare magra durante il trattamento per la perdita di peso con GLP-1. Gli studi si concentrano sui pazienti che assumono Wegovy® o Ozempic®, poiché fino al 40% della perdita di peso totale dai trattamenti GLP-1 proviene dalla massa corporea magra.
Il primo studio esaminerà i livelli di TNF-α nei pazienti con GLP-1 mostrando un'infiammazione aumentata associata alla sarcopenia (perdita progressiva della massa muscolare). TNF sta collaborando con Renova Health, che utilizzerà la sua tecnologia di intelligenza artificiale e apprendimento automatico per analizzare e identificare i pazienti ottimali e i siti di studio.
L'iniziativa mira al mercato degli GLP-1 in rapida crescita, valutato 49,3 miliardi di dollari nel 2024 e si prevede che raggiunga 105 miliardi di dollari entro il 2029, con un CAGR del 19,2% dal 2023 al 2029.
TNF Pharmaceuticals (NASDAQ: TNFA) ha comenzado una serie de estudios para evaluar su medicamento inhibidor de TNF-alfa oral, isomyosamine, para preservar la masa muscular magra durante el tratamiento de pérdida de peso con GLP-1. Los estudios se centran en pacientes que toman Wegovy® u Ozempic®, ya que hasta el 40% de la pérdida total de peso de los tratamientos GLP-1 proviene de la masa corporal magra.
El primer estudio examinará los niveles de TNF-α en pacientes con GLP-1 que muestran inflamación aumentada asociada con sarcopenia (pérdida progresiva de masa muscular). TNF está colaborando con Renova Health, que utilizará su tecnología de inteligencia artificial y aprendizaje automático para analizar e identificar grupos óptimos de pacientes y sitios de estudio.
La iniciativa apunta al mercado de GLP-1 en rápida expansión, valorado en 49,3 mil millones de dólares en 2024 y que se espera alcance 105 mil millones de dólares para 2029, con una Tasa Compuesta de Crecimiento Anual (CAGR) del 19,2% del 2023 al 2029.
TNF 제약 (NASDAQ: TNFA)는 GLP-1 체중 감량 치료 동안 지방이 아닌 근육량을 유지하기 위해 구강 TNF-알파 억제제인 이소미오사민의 연구 시리즈를 시작했습니다. 이 연구는 Wegovy® 또는 Ozempic®을 복용하는 환자에 중점을 두고 있으며, GLP-1 치료에서의 총 체중 감소의 최대 40%가 지방이 아닌 체중에서 온다는 점에 주목하고 있습니다.
첫 번째 연구는 근육량이 점진적으로 감소하는 사르코페니아와 관련된 염증이 증가한 GLP-1 환자의 TNF-α 수준을 조사할 것입니다. TNF는 레노바 헬스와 협력 중이며, AI 및 기계 학습 기술을 활용하여 최적의 환자 그룹과 연구 장소를 분석하고 식별할 것입니다.
이 이니셔티브는 2024년 493억 달러로 평가되는 빠르게 성장하는 GLP-1 시장을 겨냥하고 있으며, 2029년까지 1050억 달러에 도달할 것으로 예상되며, 2023-2029년 동안 연평균 성장률(CAGR)은 19.2%입니다.
TNF Pharmaceuticals (NASDAQ: TNFA) a lancé une série d'études pour évaluer son médicament inhibiteur oral de TNF-alpha, isomyosamine, afin de préserver la masse musculaire maigre pendant le traitement de perte de poids par GLP-1. Les études se concentrent sur les patients prenant Wegovy® ou Ozempic®, car jusqu'à 40 % de la perte de poids totale résultant des traitements GLP-1 provient de la masse corporelle maigre.
La première étude examinera les niveaux de TNF-α chez les patients GLP-1 présentant une inflammation accrue associée à la sarcopénie (perte progressive de masse musculaire). TNF collabore avec Renova Health, qui utilisera sa technologie d'intelligence artificielle et d'apprentissage automatique pour analyser et identifier des groupes de patients optimaux et des sites d'étude.
L'initiative vise le marché des GLP-1 en forte croissance, évalué à 49,3 milliards de dollars en 2024 et prévu d'atteindre 105 milliards de dollars d'ici 2029, avec un taux de croissance annuel composé (CAGR) de 19,2 % de 2023 à 2029.
TNF Pharmaceuticals (NASDAQ: TNFA) hat eine Reihe von Studien eingeleitet, um sein orales TNF-alpha-Inhibitor-Medikament isomyosamine zur Erhaltung der fettfreien Muskelmasse während einer GLP-1 Gewichtsreduktionstherapie zu evaluieren. Die Studien konzentrieren sich auf Patienten, die Wegovy® oder Ozempic® einnehmen, da bis zu 40% des gesamten Gewichtsverlusts aus GLP-1-Behandlungen aus fettfreier Körpermasse stammt.
Die erste Studie wird die TNF-α-Spiegel bei GLP-1-Patienten untersuchen, die eine erhöhte Entzündung im Zusammenhang mit Sarkopenie (fortschreitender Verlust der Muskelmasse) aufweisen. TNF arbeitet mit Renova Health zusammen, das seine KI- und Machine-Learning-Technologie nutzen wird, um optimale Patientengruppen und Studienstandorte zu analysieren und zu identifizieren.
Die Initiative zielt auf den schnell wachsenden GLP-1-Markt ab, der 2024 auf 49,3 Milliarden US-Dollar geschätzt wird und bis 2029 auf 105 Milliarden US-Dollar anwachsen soll, mit einer durchschnittlichen jährlichen Wachstumsrate (CAGR) von 19,2% von 2023 bis 2029.
- Entry into high-growth GLP-1 market worth $49.3B in 2024
- Strategic partnership with Renova Health for AI-powered patient analysis
- Targeting large addressable market with obesity costing US healthcare $173B annually
- Still in clinical stage with no approved products
- Studies are in early observational phase without proven efficacy
Insights
The launch of TNF Pharmaceuticals' study series represents a strategic move to address a critical gap in the booming GLP-1 market. While GLP-1 agonists like Wegovy® and Ozempic® have revolutionized weight loss treatment, the concerning 40% lean mass loss represents a significant medical challenge that could impact long-term patient outcomes.
The focus on TNF-alpha inhibition through isomyosamine is particularly noteworthy. TNF-alpha is a key inflammatory mediator in muscle wasting conditions and its targeted inhibition could potentially preserve muscle mass without interfering with the primary weight loss mechanisms of GLP-1s. This approach could create a valuable complementary therapy in the $100B projected GLP-1 market.
The partnership with Renova Health adds a important technological edge through AI-driven patient selection. This could accelerate study timelines and improve outcome predictions, potentially reducing development costs and increasing success probability. The phased approach, starting with observational studies of inflammation markers, demonstrates a methodical scientific strategy that could de-risk the development process.
For investors, this represents a calculated entry into the high-growth GLP-1 market through a complementary rather than competitive approach. Success in this program could position TNF Pharmaceuticals as a key player in optimizing GLP-1 therapy outcomes, particularly given the growing concerns about muscle mass preservation in long-term weight management.
The market opportunity here is compelling from multiple angles. With GLP-1s projected to grow from
What's particularly interesting is TNF's positioning strategy. Rather than competing directly with established GLP-1 players, they're developing a complementary therapy that could become a standard add-on treatment. This approach could facilitate faster market adoption and potential partnership opportunities with major GLP-1 manufacturers.
The AI-driven study design through Renova Health partnership indicates a sophisticated approach to clinical development that could accelerate time-to-market while optimizing resource allocation. This tech-enabled efficiency could provide significant competitive advantages in development speed and cost management.
Series of studies to observe signals of inflammation and TNF-alpha levels in patients taking GLP-1s including Wegovy® or Ozempic®
Lean body mass accounts for up to
Potential entry into high growth GLP-1 market of nearly
“The body of evidence for the GLP-1 drug class shows that up to
The first study examines TNF-α levels in patients receiving the GLP-1 agonist Wegovy® or Ozempic® who show signs of increased inflammation associated with sarcopenia, which is the progressive loss of muscle mass. Isomyosamine targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia.
“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,” Dr. Glass continued. “Our collaboration partner, Renova Health, is using its proprietary AI and machine learning technology to analyze and identify optimal patient pools and study sites, enabling an efficient progression of our study series over the coming months.”
"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.”
Valued at
About Isomyosamine
Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.
About TNF Pharmaceuticals, Inc.
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch, the success and timing of, the Company’s planned trial of isomyosamine (MYMD-1®) as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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1 Drug Discovery and Development, March 2024
2 Research and Markets, GLP-1 Market: Industry Trends and Global Forecasts to 2035…., August 2024
3 Global Data, March 2024
4 Centers for Disease Control and Prevention (CDC), About Obesity, January 2024
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Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com
Source: TNF Pharmaceuticals, Inc.
FAQ
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