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news.The US Food and Drug Administration (FDA) had approved TaiwanJ Pharmaceuticals' investigational new drug (IND) application for the phase 2 clinical trial of JKB-122 on autoimmune hepatitis (AIH).
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JKB-122 is a TLR4 (Toll-like Receptor 4) antagonist on patients with AIH who are refractory to or intolerant to the existing standard of care (SOC).
Duke Clinical Research Institute (DCRI) will carry out the study in various medical centers across the US.
Andrew Muir, the principal investigator of this clinical trial at DCRI, said: "A new therapy other than the current SOC is urgently needed to reduce inflammation of the liver, thus preventing or reversing the deterioration of liver function in AIH patients."
AIH is a rare autoimmune disease with a prevalence expected around 50,000 in US alone.
It is a liver inflammation disease with changing degrees of severity that includes a spectrum of clinical symptoms.
AIH patients may develop liver fibrosis or cirrhosis in serious condition.
TaiwanJ said the emerging evidence indicate a mediating role of TLR-4, the innate immune system, in the pathogenesis and progression of AIH.
JKB-122 is an off-patent drug with properties in animal models of anti-fibrotic, immuno-modulating and anti-inflammatory activities that can avoid or reduce inflammation-associated liver damage.