TaiwanJ Pharmaceuticals Co., Ltd. Announces Positive Top-Line Results from Phase 2 Study of JKB-122 on Non-Alcoholic Fatty Liver Disease
October 24, 2018 at 03:28 am EDT
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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.
TaiwanJ Pharmaceuticals Co., Ltd. is a Taiwan-based company principally engaged in the research and development of new drugs. The Company is specialized in early research of new drugs and development of clinical drugs. The Company's products are used for the treatment of chronic liver diseases. The Company is in the development stage and not generating any revenue.