Autoimmune hepatitis (AIH) is a rare condition which causes inflammation in the liver. It can lead to cirrhosis and ultimately, liver failure. The typical treatment for patients with the disease includes immune suppressors and corticosteroids. However, these can cause serious side effects. AIH patients are in desperate need of a new, effective therapy.
According to a recent announcement from TaiwanJ Pharmaceuticals, we’re one step closer. The company has just released positive results from their Phase II clinical trial.
TaiwanJ’s Phase II trial was examining JKB-122 as a potential therapeutic option for AIH.
JKB-122 is a TLR4 antagonist. It has previously produced anti-inflammatory, anti-fibrotic, and immuno-modulating effects for chronic liver diseases. These include sonalcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD).
This Phase II trial lasted a total of 24 weeks. Each of the 20 participants were given 5mg of JKB-122 each day to start. Those who were not showing improvement were given a higher dose of the drug, increased up to 40mg. 80% of the participants followed the study to completion and 31% of them showed a response to the treatment. This percentage was statistically significant and the trial therefore achieved its primary endpoint.
Additionally, JKB-122 was found to be safe and well-tolerated by patients.
TaiwanJ is now working on their FDA application for a Phase II/III study of the drug. Their hope is to initiate this trial in the second quarter of 2019. If this trial is also successful, hopefully we will see JKB-122 become a new therapeutic option for those suffering from autoimmune hepatitis soon.
You can read more about this trial and TaiwanJ’s Autoimmune Hepatitis research here.