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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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 %).

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

“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.

Clinical Trials Arena Excellence Awards - The Benefits of Entering

Gain the recognition you deserve! The Clinical Trials Arena Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving clinical trials industry advancements. Don’t miss your chance to stand out—submit your entry today!

Nominate Now