TaiwanJ Pharmaceuticals Co., Ltd. announced the results of phase II clinical trial of JKB-122 for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) that demonstrated significant improvement on relevant diagnosis and biomarkers from the JKB-122 treated subjects after the completion of 12-week study. JKB-122 is a small molecule and a long-acting TLR4 antagonist showing anti-fibrotic, immuno-modulating, and anti-inflammatory effects for the treatments of chronic liver diseases including Non-Alcoholic Fatty Liver Disease (NAFLD), Autoimmune Hepatitis (AIH), and Non-Alcoholic Steatohepatitis (NASH). A total of 121 subjects in Taiwan participated in a phase 2, randomized, multiple-dose, double-blind, placebo-controlled study of JKB-122 for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD), focusing on both drug efficacy and safety. All subjects were divided into 3 testing groups, respectively receiving once daily 5 mg, 35 mg JKB-122, and placebo during the study. The entire testing period lasts 12 weeks. According to the unblinded results, the phase 2 study has successfully achieved its primary endpoint with the statistical significance (P<0.05) in efficacy. In 35 mg JKB-122 treated group, there were 36.9% of subjects showing statistically significant reduction by over 30% or recovering to normal value in alanine aminotransferase (ALT) with reduction of liver fat content monitored by Magnetic Resonance Spectroscopy (MRS); mean change of ALT, -18.3 IU, P=0.0067. In addition, the secondary endpoints of the trial were achieved, with 70% of subjects showing statistically significant reduction by over 30% in aspartate aminotransferase (AST); mean change of AST, -8.2 IU, P=0.0235. The whole group showed statistically significant reduction with triglyceride (TG) recovered to normal; mean change of TG, -26.0 IU, P=0.0225. There were 33% of subjects showing liver fat content (by MRS) reduced over 30%; liver fat content (by MRS) showed statistically significant reduction; mean change of liver fat content, -4.2 IU, P=0.0005. High-density lipoproteins (HDL) showed statistically significant increase; mean change of HDL, +2.7 IU, P=0.0084. Tissue inhibitor of metalloproteinase 1 (TIMP-1) showed statistically significant reduction; mean change of TIMP-1, -37.8 IU, P=0.0391.