JKB-122  is a small molecule and a long-acting TLR4 antagonist. This drug has demonstrated in preclinical models anti-fibrotic, immuno-modulating,  and anti-inflammatory activities and improvement of liver injuries by hepatoprotectant property.   JKB-122 is the lead compound of the TaiwanJ pipeline for CLD.  Currently, JKB-122 has been approved by the US FDA for a couple of Phase II Clinical Trials in different indications.

 A Phase II clinical trial in Taiwan [NCT02149368] to evaluate its anti-inflammatory efficacy before antifibrotic studies is in the patient recruiting stage in Taiwan.  The study design of the trial is a two-stage adaptive group sequential design with one planned interim analysis.  Currently, the trial is in the Stage 1 of Phase II (with 60 patients as the target).

JKB-122 has received an orphan disease designation from US FDA as well as a Phase II IND application for treating autoimmune hepatitis (AIH).  The proof of concept study was demonstrated in a preclinical model of AIH. The AIH clinical trial has been initiated in the US, led by Professor Andrew Muir at Duke Clinical Research Institute, Durham, NC .  A separate Phase II trial on JKB-122 in patients with NAFLD has been initiated by recruiting patients at Taiwan.

JKB-122 has demonstrated good clinical efficacy in patients with Crohn’s disease in three Phase 2 pilot studies by a third party.  TaiwanJ holds the patent on Crohn’s disease of JKB-122. JKB-122 as monotherapy or in combination with other agents may emerge as an alternative to standard of care but with good safety profile.
JKB-122 will be developed via FDA 505(b)(2) regulatory pathway.  A new  patentable  slow release formulation has been developed and application will be filed soon.