Non-alcoholic fatty hepatitis (NASH) new drug Namodenoson: Significant and persistent reduction in liver fat and inflammation throughout Phase II study

Can-Fite Biopharmaceuticals has announced its A3 adenosine receptor agonant Namodenoson for the treatment of non-alcoholic fatty liver disease (NAFLD) Phase II dataThe results showed that Namodenoson produced statistically significant improvements in all efficacy indicators at a dose of 25 mg, as well as strong safety and good toleranceFile photo: NamodenosonPhase II double-blind, placebo-controlled study recruited 60 NAFLD patients with or without non-alcoholic fatty hepatitis (NASH)Patients with signs of active inflammation take oral 12.5 mg (n s 21) or 25 mg (n s 19) Namodenoson twice dailyThe patient was treated for 12 weeks and followed up to 16 weeksanti-inflammatory effectsNamodenoson significantly reduced the rise of two liver enzymes in the damaged liver: tinnine transaminase (AST) and alanine transaminase (ALT), and added anti-inflammatory cytokine lipolicosin, also known as anti-fibrosis factorThe serolipid-incosin levels in the 25 mg dose group increased by 220 ng/mL, and the serolipid-linkedin levels in the 12.5 mg dose group increased by 539 ng/mL (p - 0.03)patients who achieved ALT normalization in follow-up were 36.8% in a 25 mg dose, compared with 10% in placebo (p - 0.038)At a dose of 12.5 mg, the ratio was 23.8%, and thereduced liver fibrosisshowed a statistically significant decrease in liver fibrosis in patients treated with 25 mg Namodenoson, as measured by the Fibrosis-4 (FIB-4) score compared to placeboCompared to the placebo group, the change in FIB-4 from the baseline improved by -0.089 in patients taking 25 mg Namodenoson, while the placebo group deteriorated by 0.042 points compared to the baselineFIB-4 is a non-invasive marker of liver fibrosisreduce liver fat degenerationin the Namodenoson 25 mg treatment group, the proportion of patients with a high erasde scoring decreased from 37.5% to 13.3%, while the proportion of patients with a high eras degeneration score decreased from 37.5% to 35.3% in the placebo treatment groupFat denation is evaluated by measuring The Controlled Attenuation Parameter (CAP) of FibroScanall NASH patients were relieved25% of patients randomly assigned to the Namodenoson 25 mg dose group had NASH at baseline, compared with no NASH patients in the placebo groupAfter 12 weeks of treatment, all NASH patients treated with 25 mg Namodenoson were relieved compared to 5% of new NASH patients in the placebo group, p .009NASH is evaluated by fibroScan-AST (FAST) ratings and measured by FibroScan Elastic Imaging, CAP and Serum ASTweight lossin the 25 mg and 12.5 mg Namodenoson groups, the weight loss was linearA3 adenosine receptors (A3AR)stable expression of A3AR biomarkers, indicating the presence of receptors after long-term treatment and reflecting the effectiveness of the targetsafetyNamodenoson is safe and well tolerated, with no serious adverse reactions and no hepatotoxicity