NASH is a liver disease that exists along a continuum of progressive liver deterioration and is characterized by fatty deposits, inflammation and cellular damage. Globally, an estimated 6% of the population has NASH with approximately 16 million patients in the United States as of 2015. Over time, individuals with NASH may develop scarring or fibrosis of the liver which can progress to loss of liver cells and irreversible scarring, or cirrhosis, and ultimately require liver transplant. There is an increased risk of liver cancer in NASH patients as well as a higher risk of death from cardiovascular disease.
Clinical Progression of Fatty Liver Disease
Today, there are no approved therapies for NASH, and the disease, therefore, represents a significant unmet medical need. While numerous drug targets are being explored to treat NASH, it has been challenging to demonstrate significant clinical benefit across the key disease characteristics of inflammation, ballooning and fibrosis.
Targeting FXR has been shown clinically to improve each of these three characteristics of NASH. The FXR agonist class for the treatment of NASH has evolved over time as drug developers have sought to harness its potential; however, each iteration to date has had limitations.
MET409 was purposefully designed to be an optimized next-generation FXR agonist with features of a non-bile acid chemical structure and sustained FXR engagement. With this profile, we believe MET409 has the potential to be a best-in-class NASH drug with a key differentiated safety and efficacy profile from other FXR agonists in development.
No bile acid or steroidal elements (non-bile acid)
Sustained FXR engagement
Selective and potent for FXR
Oral, once-daily dosing
Safety and Efficacy
Compliance and Convenience