Can-Fite Reports Additional Findings from Successful Phase II NASH Study: 25 mg Dose of Namodenoson Significantly Reduced Liver Fat and Fibrosis
Business Wire Business Wire•May 18, 2020
Can-Fite Reports Additional Findings from Successful Phase II NASH Study: 25 mg Dose of Namodenoson Significantly Reduced Liver Fat and Fibrosis
All cases of NASH significantly resolved after 12 weeks of treatment with Namodenoson 25 mg
Namodenoson’s safety profile and efficacy in Phase II position the drug for advanced clinical trials in the treatment of NAFLD/NASH, a projected $35 billion market by 2025
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced additional findings from its Phase II study of Namodenoson in the treatment of patients with non-alcoholic fatty liver disease (NAFLD) with or without non-alcoholic steatohepatitis (NASH). On April 7, the Company reported topline results from the Phase II study indicating Namodenoson had achieved its efficacy endpoints in a dose dependent and statistically significant manner, while continuing to demonstrate a good safety profile. Most significantly, a more recent in-depth review of the Phase II data reveal 25 mg of Namodenoson was found to resolve significantly all cases of NASH, representing 25% of the 25 mg treated group, as compared to an increase in new NASH cases in the placebo group from a baseline of 0 to 5.9%.
In the Phase II study, 25 mg of Namodenoson was shown to reduce hepatic fibrosis (scar tissue in the liver resulting from the liver trying to repair itself), reduce steatosis (fat buildup in the liver), and improve the FAST score, a measure for NASH (liver stiffness and an enzymatic biomarker of liver damage).
Hepatic Fibrosis Reduced
Patients treated with 25 mg of Namodenoson had a statistically significant reduction in hepatic fibrosis as measured by the Fibrosis-4 (FIB-4) score, as compared to placebo. FIB-4 change from baseline improved by -0.089 in patients dosed with 25 mg of Namodenoson, as compared to the placebo group which deteriorated from baseline by 0.042 points, with p=0.026. FIB-4 is a non-invasive marker of hepatic fibrosis consisting of four parameters including age, platelet counts, and two liver enzymes, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), which are elevated in a damaged liver.
Steatosis Reduced
In the Namodenoson 25 mg treated group, the proportion of patients with high steatosis scores declined from 37.5% to 13.3% of the population, as compared to the placebo treated group in which the proportion of patients with high steatosis scores decreased from 37.5% to 35.3% of the population, with p=0.08. Steatosis was assessed by Controlled Attenuation Parameter (CAP) measurement of the FibroScan, a non-invasive marker of hepatic steatosis.
NASH – All Cases Resolved
25% of patients randomized into the Namodenoson 25 mg dosed group had NASH at baseline, as compared to none in the placebo group, which comprised of patients who had NAFLD without NASH at baseline. Following 12 weeks of treatment, all NASH cases were resolved in patients treated with 25 mg of Namodenoson, as compared to new NASH that developed in the placebo group representing 5% of that population, with p<0.009. NASH was evaluated by FibroScan-AST (FAST) score, a noninvasive marker of NASH, the severe form of NAFLD (equivalent to biopsy findings of NAS≥4, F≥2), measured by FibroScan elastography, CAP and serum AST.
"The data show that Namodenoson reversed and eliminated NASH, and may prevent the progression of NAFLD into NASH. We are very pleased and impressed by these results. Given the clear need for approved drugs in this indication, we believe Namodenoson is a strong candidate for advanced stage clinical development as a treatment for both NAFLD and NASH," stated Prof. Rifaat Safadi of Hadassah Medical Center, the Principal Investigator of the study.
The Phase II double-blind, placebo-controlled, dose-finding efficacy and safety study enrolled 60 patients with NAFLD with or without NASH in three clinical sites in Israel. Patients with evidence of an active inflammation were treated twice daily with 12.5 mg (n=21) or 25 mg (n=19) of oral Namodenoson vs. placebo (n=20). The patients were treated for 12 weeks and followed-up until week 16. The study’s end points included alanine aminotransferase (ALT) and aspartate aminotransferase (AST) blood level, % of liver fat, liver stiffness, serum adiponectin, leptin and patient’s weight loss. Based on topline results, 25 mg was determined to be the optimal dosage.
An estimated 85 million Americans have NAFLD, which may lead to an exponential rise in incidence of NASH, a more severe form of NAFLD, to close to 43 million Americans in the next five years. The NASH treatment market is estimated to reach $35-40 billion by 2025.
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