Clinical trial focus: Developing JKB-122 as a new treatment for autoimmune hepatitis – principles and future directions

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Background
Autoimmune hepatitis (AIH) is a rare disease caused by the body’s immune system attacking the liver, resulting in inflammation and potentially scarring. A combination of genetics and environment may trigger the disease but the detailed mechanism for the disorder is still unknown [1].

Autoantibodies are the indicators utilized to diagnose AIH; however, serological markers and histological evidence provide the best evidence for AIH progression [2]. Alanine aminotransferase (ALT) level is the major indicator of liver inflammation; it has been demonstrated that if a patient has normalized liver function within 3 months following treatment this generally results in a good prognosis: failure to normalize liver function tests (ALT and aspartate aminotransferase (AST)) within 6 months after diagnosis increases the probability of cirrhosis and liver transplant in the long run [3].

Treatment failure, incomplete response and intolerance to the standard-of-care (SOC) occurs in 9–34 % of the AIH population [3]. Alternative treatments are provided if the patient fails to normalize liver function, defined as ALT/AST within normal ranges. However, currently alternative treatments include immunosuppressants which, while effective, may reduce overall immunity leading to infections or other serious conditions such as cardiovascular disease and de novo malignancies. [4] To this end, an alternative immune-modulator that does not suppress overall immunity may serve the unmet medical needs of AIH patients.

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