Can-Fite's Namodenoson Shows Promise in Pancreatic Cancer and Obesity Studies

Can-Fite BioPharma Ltd. (NYSE American: CANF) announced that its drug candidate namodenoson successfully met the primary endpoint in a Phase 2a study for pretreated pancreatic cancer patients. The Phase 2a study results indicated that namodenoson demonstrated a significant improvement in overall survival rates among patients. The treatment was well-tolerated, with a favorable safety profile.

Secondary endpoints included overall survival (OS) and progression-free survival (PFS). Survival follow-up remains ongoing, with 1/3 of patients currently alive at the time of data cut-off. As follow-up continues, survival outcomes are expected to further mature and will be announced during upcoming scientific meetings.

Can-Fite completed patient enrollment in its Phase 2a pancreatic cancer clinical trial of namodenoson in January. Topline efficacy data is expected in the third quarter of 2026.

The company also announced the publication of a peer-reviewed study in the International Journal of Obesity demonstrating the anti-obesity effect of namodenoson. The article, titled "The anti-obesity effect of namodenoson, an A3 adenosine receptor agonist," is now available online as an Open Access publication.

The study evaluated the effects of namodenoson in adipocytes (3T3-L1 fat cells) in vitro and in a murine high-fat diet model of obesity. The publication reports that namodenoson significantly inhibited adipocyte proliferation and lipid droplet accumulation in a dose-dependent manner. In the high-fat diet model, daily oral administration of namodenoson for four weeks resulted in a statistically significant reduction in weight gain compared to placebo-treated controls.

Mechanistically, namodenoson was shown to modulate key molecular pathways involved in adipogenesis and inflammation. Treatment upregulated adiponectin, a hormone associated with improved metabolic regulation, and suppressed PI3K, NF-κB, Akt, and Wnt/β-catenin signaling pathways, suggesting a multi-pathway metabolic mechanism.

The findings are consistent with previously reported data from a Phase IIa clinical study in patients with metabolic dysfunction-associated steatohepatitis (MASH), in which treatment with namodenoson for three months was associated with reductions in liver fat and body weight. A Phase IIb MASH study is currently enrolling patients and is designed to evaluate effects on inflammation, fibrosis, steatosis, and body weight.

In February, Can-Fite BioPharma received a Canadian patent covering the use of namodenoson for reducing fat mass and body weight, providing intellectual property protection as an anti-obesity therapy. The company reported that a patient with advanced decompensated liver cirrhosis who was treated with namodenoson subsequently underwent a successful liver transplantation.

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.

Namodenoson has demonstrated a favorable safety profile across preclinical and clinical studies and is protected by a broad patent portfolio. The global obesity treatment market is projected to reach $60.5 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 22%, driven by increasing disease prevalence and demand for safe, effective oral therapies.

In addition to the positive trial results, Can-Fite is also focusing on expanding its clinical trials to further explore the drug's efficacy in advanced liver cancer.