Pharmaceutical company TaiwanJ Pharmaceuticals said on Monday that its phase II clinical trial of JKB-122 in refractory Autoimmune Hepatitis (AIH) patients demonstrated improvement on targeted objectives and relevant biomarkers under the 24-week study.

AIH is reportedly an immune modulated chronic liver disease with unknown etiology and no effective therapeutic agents for it.

The company stated 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).

Under the clinical trial, a total of 20 subjects in US participated in the company's phase 2, escalating dose, open study of JKB-122 for the treatment of Autoimmune Hepatitis (AIH), with focus on both drug efficacy and safety. All subjects received once daily 5mg increased monthly up to 40mg JKB-122.

According to the trial results, the phase 2 study has successfully achieved its primary endpoint with the statistical significance in efficacy compare to the baseline in the responder group. The entire testing period lasts 24 weeks, 80% of the patients completed the study.

In addition, the company is carrying out further process to file the phase II/III clinical study application of JKB-122 on AIH to US FDA in Q2 2019.