TaiwanJ completed enrollment for chronic liver disease (CLD) trial

TaiwanJ’s Phase II trial on JKB-122 for CLD therapy successfully reached the target enrollment in January 2017. After receiving the approval of its IND filing from the FDA/TFDA in 2014 Q1, TaiwanJ rolled out the trial to eligible subjects at the study sites in both Taiwan and the US. The trial result is anticipated to disclose in 2017 Q3 when the data analysis is complete. 

In 2016, WHO reported that chronic hepatitis C virus infection affected an estimated 130-150 million globally. A significant number of those will develop liver fibrosis and liver cirrhosis or liver cancer. Approximately 700,000 people die each year from hepatitis C-related liver diseases. In recent years, direct-acting antiviral (DAA) therapeutics also became available in the market and can cure approximately 90% of persons with hepatitis C infection, thereby reducing the risk of death from liver cancer and cirrhosis. However, the access to diagnosis and treatment still remains low. Moreover, the antivirals are only effective in treating viruses, not CLD, and these DAA drugs are also too expensive for many chronic HCV patients not receiving governmental subsidies for their medical care. 

JKB-122 is an antagonist of Toll-like receptor 4 (TLR4) which is part of human innate immune system and a key mediator of the release of pro-inflammatory cytokines.  Through modulating TLR4 signaling, JKB-122 exerts its anti-inflammatory effects and ameliorates hepatitis and ensuing liver fibrosis. Currently there is no approved therapeutic available in the market to treat patients with CLD resulting from HCV infections. JKB-122 is a repositioned product of an FDA-approved drug. It has a good safety profile and could likely become a top choice for treating chronic liver disease due to HCV, HBV and other causes.

Taiwanj Pharmaceuticals, listed in Taipei Exchange, is an emerging specialty pharma actively engaged in drug development for liver diseases.