Can-Fite Files IND for Namodenoson Phase IIb MASH Trial

Can-Fite BioPharma, a company specializing in the development of innovative pharmaceuticals for cancer and inflammatory diseases, has submitted an IND application to the FDA for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). The company is currently conducting a Phase IIb clinical study for this condition, with patient recruitment actively underway in Europe and Israel.

The drug in question, Namodenoson, has demonstrated the ability to alleviate liver fat, inflammation, and scarring, as well as assist in weight reduction. These findings were part of a Phase IIa study, the results of which have been published in a respected scientific journal. Can-Fite is now seeking FDA approval to expand the study to include participants from the United States.

The Phase IIb trial is designed to be a multicenter, randomized, double-blind, placebo-controlled study involving subjects diagnosed with MASH through a biopsy. The primary goal is to assess the effectiveness of Namodenoson compared to a placebo in 140 MASH patients, using histological endpoints as the benchmark. Participants will be randomly assigned to receive either Namodenoson 25 mg orally every 12 hours or an equivalent placebo for a period of 36 weeks.

Can-Fite's CEO, Motti Farbstein, expressed enthusiasm for the potential therapeutic impact of Namodenoson on MASH patients. He highlighted that previous human studies have shown significant anti-MASH effects from the drug's treatment. The unique liver-protective mechanism of Namodenoson could offer substantial therapeutic benefits by potentially reducing inflammation and liver fat and scarring.

The prevalence of MASH in the United States is on the rise, paralleling the increasing rates of obesity and diabetes, and is projected to affect 2-5% of adult Americans. By 2028, the pharmaceutical market for MASH is expected to reach $21.9 billion. The recent FDA approval of Rezdiffra (resmetirom) for MASH treatment with moderate to advanced liver fibrosis by Madrigal Pharmaceuticals in March 2024 signals a growing interest in drugs targeting this significant market.

Namodenoson is an orally administered drug that selectively binds to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells and less so in healthy cells. This selective action contributes to the drug's favorable safety profile. Can-Fite BioPharma is an advanced clinical stage company with a platform technology aimed at addressing significant markets in cancer, liver, and inflammatory disease treatments. Their lead drug candidate, Piclidenoson, recently reported topline results in a Phase III trial for psoriasis and is anticipated to initiate a pivotal Phase III study. The company is also planning a Phase IIa study for pancreatic cancer and has received Orphan Drug Designation and Fast Track Designation for Namodenoson from the FDA.