TaiwanJ attained the enrollment milestone in NASH trial
2017-01-12

With the completion of subject recruitment in mid December, 2016, TaiwanJ Pharmaceuticals recently announced that its Phase II trial on JKB-121 for nonalcoholic steatohepatitis (NASH) therapy successfully reached enrollment milestone.  The trial was initiated in the 3rd quarter of 2015 after USFDA granted the IND filing, with ensuing subject recruitment conducted at 13 study sites across the United States.   Subjects eligible for the trial are diagnosed with NASH  (NAS > 4), hepatic fibrosis, and elevated fat (hepatic steatosis) and liver enzymes. The trial comprises safety and efficacy of JKB-121 as a treatment for NASH. The trial results are expected in the 3rd quarter of 2017. 

JKB-121, repositioned as a first-in-class medication of NASH, has an excellent safety profile in clinical use. JKB-121 can be a versatile drug for treating NASH; through modulation of Toll-Like Receptor 4 (TLR-4), JKB-121 demonstrates therapeutic effects against activated hepatic stellate cells (HSC), multiple pathological features of NASH in animal studies, including accumulation of hepatic fat, elevated liver enzymes (AST and ALT), inflammatory hepatic injury, and fibrosis progression.  Blocking TLR-4 can blunt down-stream inflammatory and fibrogenic pathways, prevent lipid-induced insulin resistance, and ameliorate NASH.

NASH therapeutics are a global unmet medical need with a huge potential market, where big pharmas and small biotech companies have been racing fiercely in recent years to come up with the first FDA-approved drug for NASH, likely by 2019. The market value of NASH medication will reach 38 billion USD by 2030 as estimated by Deutsche Bank and some market consulting firms.