TaiwanJ Pharmaceuticals Gains FDA Approval for Entering Phase 2 Clinical Study on Autoimmune Hepatitis, an Orphan Disease

    ZHUBEI, TAIWAN, October 16, 2015 /24-7PressRelease/ -- TaiwanJ Pharmaceuticals announced that the US Food and Drug Administration (FDA) had approved its IND application for the Phase 2 clinical trial of JKB-122, a TLR4 (Toll-like Receptor 4) antagonist, on patients with autoimmune hepatitis (AIH) who are refractory to or intolerant to current standard of care (SOC). AIH is an orphan disease and currently there is no clinically effective treatment except for steroids. The trial will be conducted by Duke Clinical Research Institute (DCRI) in several medical centers in the U.S.

Said Dr. Andrew Muir, the Principal Investigator of this clinical trial at DCRI, "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 estimated around 50,000 in US alone. The causes for AIH are not fully understood. However, it is a liver inflammation disease with varying degrees of severity that includes a wide spectrum of clinical symptoms. In serious condition, AIH patients may develop liver fibrosis or cirrhosis. The emerging evidence suggests a mediating role of TLR-4, the innate immune system, in the pathogenesis and progression of AIH.

Prednisone or budesonide, which is often combined with azathioprine, is the current regimen to treat AIH. Most AIH cases are chronic and patients need to be on steroid-based medication for a long period which inevitably results in developing steroid-related side effects. However, a sudden withdrawal of the medication is not recommended. Statistic figures of epidemiology indicate that 88% of the AIH patients who stop the medication will relapse within five years, and the frequency of relapse is highly correlated with the terminal stage of liver diseases, liver cirrhosis for instance. Therefore, developing a drug like TaiwanJ's JKB-122 that is tailored to treat AIH with minor side effects just meets the medical need.

TaiwanJ Pharmaceuticals Co., Ltd., headquartered in Hsinchu Biomedical Science Park, Taiwan, is an emerging clinical stage specialty pharmaceutical company. TaiwanJ has developed a pipeline of compounds for treating chronic liver diseases (fatty liver disease, liver inflammation, and liver fibrosis), GI diseases, and cancer.

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