TNF Pharmaceuticals Delivers Podium Presentation of Novel Oral TNF-Alpha Inhibitor at Premier International Conference on Frailty and Sarcopenia
TNF Pharmaceuticals (NASDAQ: TNFA) presented positive Phase 2a clinical trial data for its oral TNF-alpha inhibitor drug candidate isomyosamine at the 15th International Conference on Frailty and Sarcopenia Research (ICFSR) in Toulouse, France.
The data demonstrated decreases in biomarkers associated with TNF-α activation in elderly patients with sarcopenia. The company has initiated a Phase 2b clinical trial to evaluate isomyosamine as a treatment for chronic inflammation associated with muscle loss in patients recovering from hip or femur fracture repair surgery.
According to Dr. Mitchell Glass, President and Chief Medical Officer, the presented data supports the rationale for their current Phase 2b study and optimal oral dosing regimen, focusing on isomyosamine's potential for regulating pro-inflammatory cytokines associated with sarcopenia.
TNF Pharmaceuticals (NASDAQ: TNFA) ha presentato dati positivi della fase 2a dello studio clinico per il suo candidato farmaco inibitore della TNF-alfa orale isomyosamine durante la 15ª Conferenza Internazionale sulla Ricerca sulla Fragilità e Sarcopenia (ICFSR) a Tolosa, Francia.
I dati hanno dimostrato riduzioni nei biomarcatori associati all'attivazione della TNF-α in pazienti anziani con sarcopenia. L'azienda ha avviato un studio clinico di fase 2b per valutare l'isomyosamine come trattamento per l'infiammazione cronica associata alla perdita muscolare in pazienti in fase di recupero dopo un intervento chirurgico per riparare fratture dell'anca o del femore.
Secondo il Dr. Mitchell Glass, Presidente e Direttore Medico, i dati presentati supportano la giustificazione per il loro attuale studio di fase 2b e il regime di dosaggio orale ottimale, concentrandosi sul potenziale dell'isomyosamine nel regolare le citochine pro-infiammatorie associate alla sarcopenia.
TNF Pharmaceuticals (NASDAQ: TNFA) presentó datos positivos del ensayo clínico de fase 2a para su candidato a fármaco inhibidor oral de TNF-alfa isomyosamine en la 15ª Conferencia Internacional sobre Investigación en Fragilidad y Sarcopenia (ICFSR) en Toulouse, Francia.
Los datos demostraron disminuciones en los biomarcadores asociados con la activación de TNF-α en pacientes ancianos con sarcopenia. La empresa ha iniciado un ensayo clínico de fase 2b para evaluar el isomyosamine como tratamiento para la inflamación crónica asociada con la pérdida muscular en pacientes en recuperación de cirugía de reparación de fracturas de cadera o fémur.
Según el Dr. Mitchell Glass, Presidente y Director Médico, los datos presentados respaldan la justificación para su estudio actual de fase 2b y el régimen de dosificación oral óptimo, centrándose en el potencial del isomyosamine para regular las citoquinas proinflamatorias asociadas con la sarcopenia.
TNF Pharmaceuticals (NASDAQ: TNFA)는 프랑스 툴루즈에서 열린 제15회 국제 노화 및 근감소증 연구 회의(ICFSR)에서 경구 TNF-알파 억제제 후보물질 isomyosamine의 긍정적인 2a상 임상 시험 데이터를 발표했습니다.
이 데이터는 근감소증이 있는 노인 환자에서 TNF-α 활성화와 관련된 바이오마커의 감소를 보여주었습니다. 이 회사는 고관절 또는 대퇴골 골절 수술 후 회복 중인 환자에서 근육 손실과 관련된 만성 염증 치료를 평가하기 위해 2b상 임상 시험을 시작했습니다.
미첼 글래스 박사(사장 겸 최고 의료 책임자)에 따르면, 발표된 데이터는 현재의 2b상 연구와 최적의 경구 투여 요법의 정당성을 뒷받침하며, 근감소증과 관련된 염증성 사이토카인의 조절에 대한 isomyosamine의 잠재력에 초점을 맞추고 있습니다.
TNF Pharmaceuticals (NASDAQ: TNFA) a présenté des données positives d'essai clinique de phase 2a pour son candidat médicament inhibiteur oral de TNF-alpha isomyosamine lors de la 15e Conférence Internationale sur la Recherche sur la Fragilité et la Sarcopénie (ICFSR) à Toulouse, France.
Les données ont montré des diminutions des biomarqueurs associés à l'activation de TNF-α chez les patients âgés souffrant de sarcopénie. L'entreprise a lancé un essai clinique de phase 2b pour évaluer l'isomyosamine comme traitement de l'inflammation chronique associée à la perte musculaire chez les patients en convalescence après une chirurgie de réparation de fracture de la hanche ou du fémur.
Selon le Dr Mitchell Glass, Président et Directeur Médical, les données présentées soutiennent la justification de leur étude actuelle de phase 2b et le schéma posologique oral optimal, en mettant l'accent sur le potentiel de l'isomyosamine à réguler les cytokines pro-inflammatoires associées à la sarcopénie.
TNF Pharmaceuticals (NASDAQ: TNFA) hat auf der 15. Internationalen Konferenz zur Forschung über Fragilität und Sarkopenie (ICFSR) in Toulouse, Frankreich, positive Daten aus der Phase 2a klinischen Studie für seinen oralen TNF-alpha-Inhibitor-Kandidaten isomyosamine präsentiert.
Die Daten zeigten Rückgänge bei Biomarkern, die mit der Aktivierung von TNF-α bei älteren Patienten mit Sarkopenie verbunden sind. Das Unternehmen hat eine Phase 2b klinische Studie gestartet, um isomyosamine als Behandlung für chronische Entzündungen, die mit Muskelverlust bei Patienten nach einer Hüft- oder Oberschenkelhalsfraktur-Operation verbunden sind, zu bewerten.
Laut Dr. Mitchell Glass, Präsident und Chief Medical Officer, unterstützen die präsentierten Daten die Begründung für ihre aktuelle Phase 2b-Studie und das optimale orale Dosierungsschema, mit einem Fokus auf das Potenzial von isomyosamine zur Regulierung proinflammatorischer Zytokine, die mit Sarkopenie assoziiert sind.
- Positive Phase 2a clinical data showing decreased TNF-α activation biomarkers
- Advancement to Phase 2b clinical trials
- Successful podium presentation at major international conference
- None.
Positive clinical data validates current Phase 2b clinical trial of isomyosamine as a treatment for chronic inflammation associated with muscle loss
The presentation included positive Phase 2a clinical data showing decreases of biomarkers associated with TNF-α activation in elderly patients with sarcopenia. The Company’s recently initiated Phase 2b clinical trial will further evaluate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.
“We were proud to speak about our compelling clinical data for isomyosamine at ICFSR’s premier annual conference on sarcopenia. The data presented showcases the rationale for our current Phase 2b study in elderly sarcopenia patients and the optimal oral dosing regimen going forward,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “We are further exploring isomyosamine’s potential for regulating pro-inflammatory cytokines associated with sarcopenia with an assessment of the drug’s impact on the recovery of mobility and independence for these elderly patients.”
The ICFSR conference was created with the objective to speed the development of high-quality clinical trials in frail older adults by sharing experiences, success and failure alike, to accelerate the discovery of treatments, prevention methods for healthy aging and prevention of disabilities and dependency in older adults.
About Isomyosamine
Isomyosamine (ICD-10-CM code M62.84) 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 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 and the timing of the Company’s planned trial of isomyosamine 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.
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