Non-Alcoholic Steatohepatitis 2017 Progress Update

Big-time investors of late have been investing a substantial portion of their R&D sources for the treatment of Non-Alcoholic Steatohepatitis (NASH). The market for NASH is poised to witness rapid growth unlike other lucrative but saturated markets like cancer.

A chronic liver disease, NASH is caused by excessive fat accumulation in the liver which in turn is known as steatosis. NASH is known to affect up to 15 million people in the United Stated and could lead inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. It is expected to be the leading cause for liver transplantation by 2020. Notably, it is currently the leading cause of liver transplants for people under 50 in the United States.

NASH patients are also known to be affected by obesity and type II diabetes. The disease is prevalent in European countries along with developing countries. The market for this disease is projected around $20-$35 billion. With no treatments currently approved for this disease, the market opportunity is significant.

Let us take a look at the companies whose candidates are being evaluated at present for the treatment of NASH.

Intercept Pharmaceuticials, Inc. ICPT is presently evaluating lead drug Ocaliva. The drug is already approved in the United States for the treatment of primary biliary cholangitis (PBC) with an inadequate response to or intolerant to the standard of care, UDCA. The company currently has an ongoing phase III trial, REGENERATE, in non-cirrhotic NASH patients with liver fibrosis and top-line data from interim analysis is expected in the first half of 2019.

The company also completed a phase II trial, CONTROL, to evaluate the lipid metabolic effects of Ocaliva and cholesterol management effects of concomitant statin administration in NASH patients. The company also plans to initiate a phase III trial in NASH patients with cirrhosis in the second half of 2017. Given the success of the phase II trial, we expect Intercept to be one of the first companies to obtain an approval for NASH.

Biotech bigwig Gilead Sciences Inc. GILD also has quite a few programs for patients diagnosed with NASH along with advanced fibrosis. These include selonsertib (ASK-1 inhibitor; phase III), GS-9674 (FXR agonist; phase II) and GS-0976 (ACC inhibitor; phase II). The company plans to initiate combination studies with three agents in 2017.

Given the increasing competition in once lucrative hepatitis C market, Gilead is looking to diversify its portfolio and foray into emerging fields of CAR T therapy and NASH. The company earlier acquired Phenex’s farnesoid X receptor program comprising small molecule FXR agonists for the treatment of liver diseases including NASH.

Another major player in the biotech space, Bristol-Myers Squibb Company BMY has a mid-stage candidate in the NASH space. BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21), a key regulator of metabolism, in patients with biopsy-confirmed NASH (F1-F3) achieved its primary endpoint of significant reduction in liver fat versus placebo in April. The company was entitled the rights to research, develop and commercialize BMS-986036 from Ambrx, Inc.

Swiss major Novartis Inc. NVS entered into a clinical trial agreement with Allergan plc AGN to conduct a phase IIb study in April, involving the combination of a Novartis FXR agonist and Allergan's cenicriviroc for the treatment of NASH. The company has a collaboration and license agreement with Conatus Pharmaceuticals Inc. CNAT for the global development and commercialization of emricasan for patients with decompensated liver cirrhosis caused by NASH.

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Bottom Line

Given the potential in the market, there are many other big pharma and biotech companies having pipeline candidates for the treatment of NASH. We expect a lot of activity in the space going forward. A potential approval of any drug for NASH will attract more players.

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