Namodenoson Improves Decompensated Liver Cirrhosis Episodes

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Treatment with Namodenoson resulted in positive effects in a patient with decompensated liver cirrhosis treated under a compassionate use program in Israel, according to an announcement from Can-Fite BioPharma.¹

According to a February 18, 2025, press release, at 20 months of treatment, the patient has reported notable improvements in symptoms related to the disease, including fatigue and edema. Additionally, since beginning therapy, the patient has not experienced any gastrointestinal bleeding episodes, their moderate ascites has gradually resolved, their liver stiffness has declined, and their elevated globulin levels have started to decrease.¹

"The patient's positive response to Namodenoson is extremely encouraging. We currently have very limited options for treating patients with decompensated liver disease beyond liver transplantation. Unfortunately, due to a shortage of donor organs, many patients die while waiting for a transplant,” commented Ohad Etzion, MD, chief of gastrointestinal and liver diseases at Soroka Medical Center in Israel.¹ “Namodenoson may offer a potential solution by stabilizing the disease and providing patients with precious time until a transplant becomes available.”

A small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor, Namodenoson is currently being evaluated in a phase 3 trial for advanced liver cancer, a phase 2b trial for the treatment of metabolic dysfunction-associated steatohepatitis, and a phase 2a study in pancreatic cancer, an indication for which it has been granted US Food and Drug Administration Orphan Drug Designation.^1,2

Can-Fite previously initiated a compassionate use program at the Soroka Medical Center, Beersheva, Israel, for the treatment of decompensated patients with Namodenoson. The first patient to receive the drug under the program was a 63-year-old female with a history of decompensated primary biliary cirrhosis. Prior to the treatment with Namodenoson and despite best medical care, she developed ascites and was admitted to the hospital with acute variceal bleeding.³

Decompensated cirrhosis is often associated with liver failure and currently has no approved therapeutic options other than liver transplantation. While some drugs can treat symptoms, no therapeutic approach has shown efficacy in slowing disease progression.¹

An estimated 1 in 400 adults in the United States have cirrhosis, although actual numbers may be higher than that because many people with cirrhosis are not diagnosed due to a lack of symptoms until later stages. As cirrhosis gets worse, the liver begins to fail, and a transplant is eventually required.⁴

In the United States, more than 103,000 people are currently on the national transplant waitlist, nearly 10,000 of whom are seeking a liver transplant. According to data from the Organ Procurement and Transplantation Network, 17 people die each day while waiting for a transplant, underscoring the need for effective therapies that stabilize disease until a transplant becomes available.⁵

References

1. Can-Fite BioPharma. Disappearance of Decompensated Liver Cirrhosis Episodes After Treatment with Can-Fite's Namodenoson. February 18, 2025. Accessed February 18, 2025. https://ir.canfite.com/news-events/press-releases/detail/1077/disappearance-of-decompensated-liver-cirrhosis-episodes

2. Can-Fite BioPharma. FDA Grants Orphan Drug Designation to Can-Fite’s Namodenoson for Pancreatic Cancer. October 9, 2024. Accessed February 18, 2025. https://ir.canfite.com/news-events/press-releases/detail/1068/fda-grants-orphan-drug-designation-to-can-fites

3. Can-Fite BioPharma. Improvement in Patient with Decompensated Liver Cirrhosis Upon Treatment with Namodenoson. July 1, 2024. Accessed February 18, 2025. https://ir.canfite.com/news-events/press-releases/detail/1059/improvement-in-patient-with-decompensated-liver-cirrhosis

4. National Institutes of Health. Cirrhosis. June 2023. Accessed February 18, 2025. https://www.niddk.nih.gov/health-information/liver-disease/cirrhosis/definition-facts

5. Health Resources & Services Administration. Organ Donation Statistics. October 2024. Accessed February 18, 2025. https://www.organdonor.gov/learn/organ-donation-statistics