Nonalcoholic steatohepatitis, or NASH, is one of the most rapidly growing health problems around the world. A form of nonalcoholic fatty liver disease, NASH causes inflammation of the liver that results in damage to the organ, which itself can lead to scarring of the liver, known as cirrhosis. And eventually, that can lead to liver failure, liver cancer or death.

Still, to date there are no drugs specifically approved by the Food and Drug Administration or other regulators for NASH. NAFLD, NASH and NASH with advanced fibrosis are often associated with Type 2 diabetes, and according to an October 2019 meta-analysis, the global incidence of NASH among people with Type 2 diabetes is about 37%.

Nevertheless, several companies have been working to develop drugs for NASH, including one that could win FDA approval this year and another that could get approval next year. Below are four companies that have drugs for NASH in Phase III development or have them under FDA review.

Intercept Pharmaceuticals

  • NASDAQ: ICPT
  • Headquarters: New York
  • Market cap: $3.2 billion

An FDA advisory committee meeting is scheduled for April 22 to discuss whether or not to recommend Intercept’s obeticholic acid for approval to treat fibrosis associated with NASH. If the agency approves the drug, that would make obeticholic acid – or OCA – the first-ever approved drug for the disease, hitting the market as early as the first half of this year.

Intercept’s application is based on results of the Phase III REGENERATE study of nearly 2,500 patients, which have shown that the drug can successfully improve fibrosis without worsening of the disease. That endpoint, along with resolution of NASH, is one of the two that the FDA has recognized as being valid for winning approval.

Genfit

  • EPA: GNFT
  • Headquarters: Lille, France
  • Market cap: 641.6 million ($697.7 million)

Coming in at second place is Genfit, whose lead candidate for NASH is elafibranor. The company plans to release data from its Phase III study during the first quarter of this year, with an eye on filing for approval with the FDA in the fourth quarter, assuming those data are positive.

While that would position elafibranor for approval next year and a launch in June 2021, CEO Pascal Prigent said in an interview that it would necessarily be competing against Intercept’s OCA, but would serve a complementary role. That’s because it is designed to bring about resolution of NASH rather than targeting fibrosis, making combination of the two a possibility.

Madrigal Pharmaceuticals

  • NASDAQ: MDGL
  • Headquarters: West Conshohocken, Pennsylvania
  • Market cap: $1.4 billion

Like Genfit, Madrigal is developing its drug, resmetirom, for resolution of NASH, particularly in patients who do not have cirrhosis and have stage 2 or stage 3 liver fibrosis. The company is running a Phase III clinical trial of 2,000 patients that it initiated in March of last year and that is expected to reach its primary completion date in June of 2021 – around the time that Genfit is expected to launch its drug.

The company published Phase II data in The Lancet in November, showing that patients treated with resmetirom showed a relative reduction in fat around the liver compared with those receiving placebo.

Allergan

  • NYSE: AGN
  • Headquarters: Dublin
  • Market cap: $66.3 billion

At the moment, Allergan is best known for its pending $63 billion acquisition by Chicago-based drugmaker AbbVie, in one of the largest biopharma acquisition deals to be announced last year.

But Allergan is also among companies with a Phase III drug for NASH. The drug is called cenicriviroc, or CVC, which Allergan acquired control of when it took over Tobira Therapeutics for $1.7 billion in 2016. CVC is in the Phase III AURORA trial, which opened in April 2017 and is set to enroll 2,000 patients. Like OCA, the drug is designed to improve fibrosis of the liver. Primary completion of the study is expected in October 2021.

Other companies in late-stage development

Numerous other companies are also moving NASH drugs into Phase III or later development, but these tend to be further behind the aforementioned four. These include:

Galmed Research and Development: Phase III/IV ARMOR study initiated in September 2019, primary completion in June 2022.

TaiwanJ Pharmaceuticals: Phase III study of JKB-122 expected to initiate in June 2020

Cirius Therapeutics: Phase III study of MSDC-0602K expected to initiate in early 2020

Photo: Sakramir, Getty Images



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