Positive clinical data validates commencement of a larger Phase 2b clinical trial in elderly patients post-hip fracture
Drug shown to decrease biomarkers associated with TNF-alpha activation in elderly patients with sarcopenia
BALTIMORE, April 16, 2025--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) ("TNF" or the "Company"), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, announced today that a platform presentation of an abstract titled "Isomyosamine for the Treatment of Sarcopenia in Older Adults" was delivered by Mitchell Glass, M.D., President and Chief Medical Officer of TNF, at the British Geriatrics Society (BGB) Spring Meeting 2025, held April 9-11, 2025, in Belfast, Ireland and online.
During his presentation, Dr. Glass spoke about the Company’s small-molecule TNF-alpha (TNF-α) inhibitor, isomyosamine, which has shown potential for regulating pro-inflammatory cytokines associated with sarcopenia. In response to a question, he emphasized the Company's commitment to sarcopenia as an initial indication, including muscle wasting as an effect of treatment with GLP-1 agonists. He also commented on the Company's plans to extend Phase 3 into the UK and Europe.
"An earlier Phase 2 study of isomyosamine demonstrated its safety and tolerability in elderly patients with sarcopenia, with significant reductions in inflammatory biomarkers such as TNF-α, IL-6, and soluble TNF receptor 1 (sTNFR1). We are currently enrolling patients in a larger Phase 2b clinical trial that will investigate isomyosamine’s effect on cellular inflammation and recovery of ambulation speed in elderly patients post-hip fracture. An increased sample size and more frequent dosing in the follow-up trial will enable us to better evaluate the drug's potential to improve both clinical and biochemical outcomes in sarcopenic patients," Dr. Glass explained.
The British Geriatrics Society is the membership association for professionals specializing in the healthcare of older people across the UK. Founded in 1947, BGS has over 5,000 members, and it is the only Society in the UK offering specialist expertise in the wide range of healthcare needs of older people.
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.
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, 2024, filed by the Company on April 11, 2025, 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.
