The $35 billion race to treat liver disease
Right now four companies are leading efforts to commercialize a drug to reverse the effects of NASH: Intercept Pharmaceuticals, Gilead Sciences, Allergan and French biotech GENFIT. All are in Phase 3 clinical trials.
The first to make a significant breakthrough in 2016, Intercept already has a drug called Ocaliva (obeticholic acid) that has been approved by the FDA to treat another liver disease, called primary biliary cholangitis, an autoimmune disease that can lead to cirrhosis that primarily affects women.
Gilead Sciences, which was the first to market Hep C drugs and capture a first-to-market advantage, is now in a late-stage study for Selonsertib in hopes it could become the first drug to win approval for treating NASH next year. It could follow up with other NASH drugs — FXR agonist GS-9674 and ACC inhibitor GS-0976. The company is hopeful that one of the combos of the drugs it is studying will advance to Phase 3 clinical trials in 2019.
Allergan is in Phase 3 of a global clinical trial of its drug, Cenicriviroc, which helps reduce fibrosis in NASH patients It has enrolled 2,000 patients to evaluate the effectiveness of the drug.
GENFIT is currently evaluating a drug called Elafibranor, which it claims reverses NASH to prevent fibrosis progression while giving patients cardioprotective benefits. It works by aiding proteins that maintain liver homeostasis and helps stop the main cells responsible for liver fibrosis.
Scientists are optimistic that the current wave of research will result in useful treatments for fibrosis related liver disease. We will know a lot more about this by the end of 2019 as research is moving quickly.
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