Positive clinical data validates current Phase 2b clinical trial of isomyosamine as a treatment for chronic inflammation associated with muscle loss
BALTIMORE, March 17, 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 that data from the Phase 2a clinical trial of its oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine was presented last week in a podium session at the peer-reviewed 15th International Conference on Frailty and Sarcopenia Research (ICFSR) held March 12-14, 2025, in Toulouse, France.
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.
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.
