TaiwanJ Pharmaceuticals, a specialty pharmaceutical company dedicated to the development and commercialization of small molecules for unmet medical needs such as NASH and Cancers, recently announced the results of phase II clinical trial of JKB-122 for the treatment of refractory Autoimmune Hepatitis (AIH) patients that demonstrated improvement on targeted objectives and relevant biomarkers from the JKB-122 treated subjects after the completion of 24-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).

According to the trial results, the phase 2 study has successfully achieved its primary endpoint with the statistical significance (P<0.05) in efficacy compare to the baseline in the responder group. For JKB-122, TaiwanJ Pharmaceuticals is carrying out further process to file the phase II/III clinical study application on AIH to FDA in Q2, 2019.