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The $35 billion race to treat liver disease

  • The race is on in the pharmaceutical industry to develop drugs to treat a form of fatty liver disease called nonalcoholic steatohepatitis, also known as NASH.
  • Industry experts estimate the global market for these new drugs is $35 billion.
  • The U.S. is spending $5 billion annually in health-care costs related to the disease, which include chemotherapy, transplants, tests and hospitalizations, reports the Center for Disease Analysis.
  • The National Institutes of Health estimates as many as 12 percent of U.S. adults have this disease, or 30 million people.
  • In spite of the large U.S. patient population at risk, the CDC has not addressed the crisis, and there is no FDA-approved treatment available, experts point out.

    Even worse, signs of the disease are asymptomatic, so a person often is not diagnosed with NASH until it advances to a late stage, when cirrhosis begins to ravage the body.By that point the only option is a transplant to avert death. That's because physicians typically do not screen for fatty liver disease as part of the annual physical they give patients when they analyze for other life-threatening conditions, like heart disease, diabetes, breast and colon cancer.

    A fuller discussion can be found here.

    This article was written by Lori Loannou, a friend, who is a senior editor for CNBC. I've summarized a little of it here but recommend the full article to you.

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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