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NAFLD treatment achieves liver fat reduction in phase 2 trial
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Results from a phase 2 trial of JKB-122 for treating nonalcoholic fatty liver disease demonstrated significant improvement on diagnosis and biomarkers after 12 weeks, according to a press release from TaiwanJ Pharmaceuticals.
JKB-122 is a small molecule and a long-acting toll-like receptor 4 antagonist with antifibrotic, immune-modulating and anti-inflammatory effects.
The phase 2 trial comprised 121 patients with NAFLD who received 5 mg of JKB-122, 35 mg of JKB-122 or placebo once daily over 12 weeks.
In the 35 mg group, 36.9% of patients achieved a significant reduction of liver fat by 30% or recovered to normal value of alanine aminotransferase levels (P < .05) and 70% showed a significant reduction by over 30% of aspartate aminotransferase levels. Mean change of ALT was –18.3 IU/mL (P = .0067) and mean change of AST was –8.2 IU/mL (P = .0235).
Additionally, the researchers deemed JKB-122 to be safe and well-tolerated.
TaiwanJ Pharmaceuticals plans to file the phase 3 trial application to Taiwan FDA in the second quarter of 2019.
Reference: www.taiwanj.com