Micrograph of autoimmune hepatitis. Credit: Nephron.

TaiwanJ Pharmaceuticals has reported positive results from Phase II clinical trial evaluating the efficacy and safety of JKB-122 for the treatment of patients with refractory Autoimmune Hepatitis (AIH).

JKB-122 is currently under development as a small molecule and a long-acting TLR4 antagonist.

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The solution has demonstrated anti-fibrotic, immuno-modulating, and anti-inflammatory effects for the treatments of several chronic liver diseases such as non-alcoholic fatty liver disease (NAFLD), autoimmune hepatitis (AIH), and non-alcoholic steatohepatitis (NASH).

Patients enrolled in the Phase II trial showed improvement on the targeted objectives and relevant biomarkers after being treated with JKB-122 for a period of 24 weeks.

“As an orphan drug designation, the study result of JKB-122 provides a further opportunity for the AIH treatment.”

TaiwanJ Pharmaceuticals said in a statement: “According to the trial results, the Phase II study has successfully achieved its primary endpoint with the statistical significance (P<0.05) in efficacy compared to the baseline in the responder group, mean change of ALT is -70.0 IU (80.6%), P=0.004.

“In addition, the secondary endpoints of the trial were achieved with the mean change of AST -32.8 IU (67.2%), P=0.022, the mean change of GGT -77.0 IU (66.8%), P=0.033, the mean change of ALP -17.8 IU (29.4 %).

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“Moreover, the drug JKB-122 is safe and well-tolerated in this study. As an orphan drug designation, the study result of JKB-122 provides a further opportunity for the AIH treatment.”

TaiwanJ enrolled 20 subjects in the US as part of the Phase II trial.

Subjects were treated with a once-daily dose of 5mg JKB-122, which was eventually increased to a monthly dose of up to 40mg JKB-122 in case their ALT performance was not improved during the trial.

The 24-week trial saw 31% of subjects respond positively to the study treatment.