FDA Approves Can-Fite's IND for Namodenoson Phase IIb MASH Study

RAMAT GAN, Israel-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company focused on developing small molecule drugs for cancer and inflammatory diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for Namodenoson. This clearance is for treating patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), in the company’s ongoing Phase IIb clinical trial.

Namodenoson is an orally available small molecule drug that targets the A3 adenosine receptor. This receptor is over-expressed on the surface of liver cells affected by MASH but not on normal cells, potentially making Namodenoson a very specific treatment option for MASH. In a Phase IIa clinical study, Namodenoson demonstrated its ability to reduce liver fat, inflammation, and fibrosis with a strong safety profile. Currently, Can-Fite is enrolling patients in Europe and Israel for the Phase IIb study, and the FDA’s IND approval will enable the inclusion of patients from the United States.

The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study involving subjects with biopsy-confirmed MASH. The main goal of the trial is to assess the efficacy of Namodenoson against a placebo in 140 subjects by examining a histological endpoint. Participants are randomly assigned in a 2:1 ratio to receive either 25 mg of Namodenoson or a matching placebo every 12 hours for a duration of 36 weeks.

"The IND approval for Namodenoson in the treatment of MASH patients allows us to include U.S. patients in our study, which will contribute to the diversity of the study population," said Motti Farbstein, Can-Fite CEO. "We are already enrolling patients and aim to complete recruitment in the coming months. We are dedicated to improving the lives of MASH patients and are proud to develop a potential new treatment for this disease, based on the promising efficacy shown in the Phase IIa study."

The incidence of MASH is rising in the United States, correlating with increasing rates of obesity and diabetes, and it is estimated to affect 2-5% of American adults. By 2028, Vantage Market Research projects that the pharmaceutical market for MASH will grow to $21.9 billion. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for treating MASH with moderate to advanced liver fibrosis, potentially opening avenues for more drugs targeting this significant market.

Namodenoson binds with high affinity and selectivity to the A3 adenosine receptor (A3AR), which is highly expressed in diseased cells but has low expression in normal cells, accounting for its excellent safety profile. Namodenoson has been evaluated in Phase II trials for hepatocellular carcinoma and non-alcoholic fatty liver disease (NAFLD) alongside NASH. Can-Fite BioPharma Ltd. is an advanced clinical-stage drug development company with a platform technology aimed at multi-billion dollar markets in cancer, liver, and inflammatory diseases. The company's lead drug candidate, Piclidenoson, has recently completed a Phase III trial for psoriasis and is expected to move into a pivotal Phase III trial. Namodenoson is currently undergoing a Phase IIb trial for steatotic liver disease and a Phase III trial for hepatocellular carcinoma, with additional plans for a Phase IIa study in pancreatic cancer. Namodenoson has also received Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second-line treatment for hepatocellular carcinoma by the FDA. Can-Fite’s third drug candidate, CF602, has demonstrated effectiveness in treating erectile dysfunction. These drugs have shown an excellent safety profile in clinical studies involving over 1,600 patients.