Introduction
For two decades, the scientific advance of investigative drug candidates for PBC into clinical development seemed like an illusion. FDA approval of obeticholic acid (i.e. ocaliva) in 2016 as a breakthrough therapeutics developed by Intercept (ICPT) for patients with mild PBC heightened clinical interest in developing therapeutics for non-viral liver diseases.
Seladelpar by CymaBay (CBAY) is widely believed to be a top contender for PBC therapeutics that could capture a good chunk of the addressable market. This is based on the plethora of clinically meaningful benefits, anti-cholestatic, anti-inflammatory, and anti-pruritogenic