TNF Pharmaceuticals Announces Trial to Explore Effects of Lead Candidate in Sarcopenia/Frailty Induced by GLP-1 Weight Loss Drugs
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) ha collaborato con Renova Health per studiare l'isomyosamina (MYMD-1) come trattamento per la sarcopenia e la fragilità indotte da GLP-1. Lo studio, completamente finanziato, valuterà i livelli di TNF-α nei pazienti che utilizzano Wegovy o Ozempic e mostrano infiammazione associata alla sarcopenia.
Studi indicano che fino al 40% della perdita di peso legata al GLP-1 proviene dalla massa corporea magra, inclusi i muscoli. Se avrà successo, l'isomyosamina potrebbe diventare una terapia innovativa per preservare la massa muscolare durante la perdita di peso indotta da GLP-1. Il mercato del GLP-1 è valutato 49,3 miliardi di dollari nel 2024 e si prevede che raggiungerà 105 miliardi di dollari entro il 2029.
TNFA sta attualmente conducendo uno studio di Fase 2 per la sarcopenia legata all'età e prevede di avviare uno studio di Fase 2b nel primo trimestre del 2025, dopo i risultati positivi della Fase 2a.
TNF Pharmaceuticals (NASDAQ: TNFA) se ha asociado con Renova Health para estudiar la isomiocina (MYMD-1) como tratamiento para la sarcopenia y fragilidad inducidas por GLP-1. El ensayo, totalmente financiado, evaluará los niveles de TNF-α en pacientes que usan Wegovy u Ozempic y que presentan inflamación asociada con la sarcopenia.
Los estudios indican que hasta el 40% de la pérdida de peso relacionada con GLP-1 proviene de la masa corporal magra, incluidos los músculos. Si tiene éxito, la isomiocina podría convertirse en una terapia de primera clase para preservar la masa muscular durante la pérdida de peso inducida por GLP-1. El mercado de GLP-1 está valorado en 49,3 mil millones de dólares en 2024 y se proyecta que alcanzará los 105 mil millones de dólares para 2029.
TNFA está actualmente realizando un ensayo de Fase 2 para la sarcopenia relacionada con la edad y planea lanzar un estudio de Fase 2b en el primer trimestre de 2025 después de resultados positivos de Fase 2a.
TNF Pharmaceuticals (NASDAQ: TNFA)는 GLP-1 유도 근감소증 및 허약증 치료제로서 이소미오사민(MYMD-1)을 연구하기 위해 Renova Health와 파트너십을 체결했습니다. 완전히 자금을 지원받는 이 연구는 Wegovy 또는 Ozempic을 사용하는 환자에서 근감소증과 관련된 염증을 나타내는 TNF-α 수준을 평가할 것입니다.
연구에 따르면 GLP-1 관련 체중 감소의 최대 40%가 근육을 포함한 제지방 체중에서 발생합니다. 성공한다면 이소미오사민은 GLP-1 체중 감소 동안 근육량을 보존하기 위한 최초의 치료법이 될 수 있습니다. GLP-1 시장은 2024년에 493억 달러로 평가되며, 2029년에는 1,050억 달러에 이를 것으로 예상됩니다.
현재 TNFA는 노화 관련 근감소증에 대한 2상 시험을 수행하고 있으며, 2상 A 결과가 긍정적인 경우 2025년 1분기에 2B상을 시작할 계획입니다.
TNF Pharmaceuticals (NASDAQ: TNFA) a établi un partenariat avec Renova Health pour étudier l'isomyosamine (MYMD-1) comme traitement de la sarcopénie et de la fragilité induites par le GLP-1. L'essai entièrement financé évaluera les niveaux de TNF-α chez les patients utilisant Wegovy ou Ozempic, présentant une inflammation associée à la sarcopénie.
Des études indiquent qu'environ 40 % de la perte de poids liée au GLP-1 provient de la masse corporelle maigre, y compris les muscles. Si cela réussit, l'isomyosamine pourrait devenir une thérapie de première classe pour préserver la masse musculaire pendant la perte de poids induite par le GLP-1. Le marché du GLP-1 est évalué à 49,3 milliards de dollars en 2024 et devrait atteindre 105 milliards de dollars d'ici 2029.
TNFA mène actuellement un essai de Phase 2 sur la sarcopénie liée à l'âge et prévoit de lancer une étude de Phase 2b au premier trimestre de 2025, après des résultats positifs de la Phase 2a.
TNF Pharmaceuticals (NASDAQ: TNFA) hat sich mit Renova Health zusammengeschlossen, um Isomyosamin (MYMD-1) als Behandlung für durch GLP-1 induzierte Sarkopenie und Gebrechlichkeit zu untersuchen. Die vollständig finanzierte Studie wird die TNF-α-Spiegel bei Patienten bewerten, die Wegovy oder Ozempic verwenden und Entzündungen aufweisen, die mit Sarkopenie verbunden sind.
Studien zeigen, dass bis zu 40 % des durch GLP-1 bedingten Gewichtsverlusts aus fettfreier Körpermasse, einschließlich Muskeln, stammen. Bei Erfolg könnte Isomyosamin eine erstklassige Therapie zur Erhaltung der Muskelmasse während des GLP-1-Gewichtsverlusts werden. Der GLP-1-Markt wird 2024 auf 49,3 Milliarden Dollar geschätzt und soll bis 2029 105 Milliarden Dollar erreichen.
TNFA führt derzeit eine Phase-2-Studie zur altersbedingten Sarkopenie durch und plant für das erste Quartal 2025 eine Phase-2b-Studie nach positiven Ergebnissen der Phase-2a.
- Fully funded study for potential entry into $49.3B GLP-1 market
- Market expected to reach $105B by 2029 with 19.2% CAGR
- Positive Phase 2a results in aging-related sarcopenia trial
- First-in-class therapy potential for GLP-1-induced muscle loss
- None.
Insights
This collaboration marks a strategic entry into the booming GLP-1 market, targeting a critical unmet need in muscle preservation. The focus on sarcopenia as a side effect of GLP-1 drugs like Wegovy and Ozempic represents a significant market opportunity, given that 40% of GLP-1-induced weight loss comes from lean muscle mass. With the GLP-1 market projected to reach
The partnership with Renova Health brings AI capabilities for patient selection, which could accelerate trial enrollment and optimize outcomes. The fully funded status of the trial indicates strong financial backing without diluting current shareholders. The timing aligns well with TNFA's existing Phase 2 sarcopenia program, allowing for potential synergies in clinical development.
The mechanism of targeting TNF-alpha inflammation in GLP-1-induced muscle loss is scientifically sound and could position isomyosamine as a first-in-class therapy. This represents a novel approach to addressing a major limitation of GLP-1 drugs, potentially creating a complementary treatment that could become standard of care for millions of patients.
The positioning of isomyosamine in the GLP-1 ecosystem is particularly compelling from a market perspective. The GLP-1 market's expected
The collaboration with Renova Health demonstrates smart market positioning - targeting a specific complication of popular GLP-1 drugs rather than competing directly with them. This approach could lead to faster market adoption and potential partnership opportunities with major GLP-1 manufacturers. The use of AI for patient selection suggests a more efficient, data-driven approach to clinical development, which could reduce costs and accelerate time to market.
Fully funded study to evaluate Wegovy and Ozempic patients at risk for increased inflammation associated with sarcopenic muscle deterioration
Collaboration partner to use AI and machine learning to identify targeted patient pool
Potential entry into high growth GLP-1 market valued at nearly
“The GLP-1 drug class has transformed the pharmaceutical landscape in recent years as the prevalence of obesity surges to record numbers. While GLP-1 receptor agonists are highly effective in treating overweight and obesity, rapid and extensive weight loss can bring a range of dangerous complications including sarcopenic loss of muscle mass and bone density,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “Since our lead drug targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia, we believe it could provide a much-needed solution for preserving muscle mass in GLP-1-induced weight loss.
“We look forward to collaborating with Renova Health, a leading innovator supporting superior healthcare outcomes. Together we will work to identify the optimal patient pool, sample size, dosing regimen, and other key objectives for a successful open label trial,” Dr. Glass added.
Studies have shown that up to
“Renova Health is excited to partner with TNF Pharmaceuticals,” said David Jacobs, CEO of Renova Health. “Together, we share a commitment to putting patients first and exploring innovative ways to achieve better outcomes at lower costs. This collaboration reflects our dedication to treating patients as real people, not just data points.”
Dr. Juliet Daniel, Medical Director of Renova Health, added, “This partnership combines Renova’s ‘Hyper-Personalized’ patient engagement expertise with TNFA’s promising research. Together, we aim to address key challenges in GLP-1 therapies and advance care for patients affected by inflammation and muscle loss.”
Currently valued at
According to the CDC, obesity costs the
TNFA is currently conducting a Phase 2 clinical trial of isomyosamine as a treatment for aging-related sarcopenia. Based on statistically significant positive results from the smaller Phase 2a study, the Company plans to launch a Phase 2b study early in the first quarter of 2025.
About Isomyosamine
Isomyosamine (MYMD-1®) 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 TNFα plays a causative role in the pathogenesis of various age-related diseases.
About Renova Health
Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health’s success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit www.renovahealth.care
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.
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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 |
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 and the timing of the Company’s planned trial of 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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Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com
Source: TNF Pharmaceuticals, Inc.
FAQ
What is the market size potential for TNFA's GLP-1-related treatment?
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What percentage of GLP-1 weight loss comes from lean body mass?
How will TNFA's isomyosamine potentially benefit Wegovy and Ozempic patients?
What is the partnership between TNFA and Renova Health focused on?
