NASH Race Heats up as Viking Therapeutics Announces Stellar Phase II Data

Clinical Results

San Diego-based Viking Therapeutics announced positive top-line data from a 12-week Phase II clinical trial of VK2809 in non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C). Company shares blasted 140 percent in premarket trading at the news.

NAFLD and LDL-C are part of what is generally called non-alcoholic steatohepatitis, or NASH, a chronic disease where fat accumulates in the liver. It is similar to cirrhosis of the liver but is found in people with little or no alcohol intake. It is related to the obesity epidemic. NASH and related diseases currently have no specific treatments other than lifestyle changes and treatments for high cholesterol.

VK2809 is an oral, tissue and receptor-subtype selective agonist of the thyroid beta receptor that has selectivity for liver tissue. In the trial, the drug hit its primary endpoint, showing statistically significant decreases in LDL-C compared to placebo. It also hit its secondary endpoint, statistically significant reductions in liver fat content compared to placebo.

The company plans to present data at The Liver Meeting 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) called in San Francisco November 9 to 13.

Patients receiving the drug showed reductions in LDL-C of 20 percent or more compared to those receiving placebo. They also showed statistically significant improvements in other lipids, including atherogenic proteins apolipoprotein B and lipoprotein (a).

“This proof-of-concept study demonstrates robust improvement in liver fat by VK2809 versus placebo,” said Rohit Loomba, director, NAFLD Research Center and professor of medicine, University of California, San Diego (UCSD), in a statement. “The trial utilized a state-of-the-art method, MRI-PDFF, as a non-invasive quantitative biomarker of changes in liver fat content. Previous studies by our group have shown that a 30 percent or greater reduction in MRI-PDFF is associated with higher odds of histologic response in NASH. The quantum of liver fat reduction along with LDL-lowering properties of VK2809 are potentially likely to be beneficial in patients with non-alcoholic steatohepatitis (NASH) who have a significant risk of not only liver fibrosis progression but also cardiovascular disease.”

The drug also appears safe, with no serious adverse events observed.

NASH is an area of interest to quite a number of companies, including Madrigal Pharmaceuticals, Gilead Sciences, Intercept Pharmaceuticals, GENFIT, Novo Nordisk, Shire, Novartis and Allergan.

Probably the company closest to having a product for NASH on the market is Intercept Pharmaceuticals, which expects a readout of its Phase III REGENERATE clinical trial in the first half of 2019. It is looking at obeticholic acid (OCA). OCA is on the market as Ocaliva for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA or as monotherapy for adults unable to tolerate UDCA.

Brian Lian, chief executive officer of Viking, stated, “We are encouraged by the preliminary efficacy and safety profile VK2809 has shown in this study. VK2809’s effect on liver fat at 12 weeks appears to exceed all other oral agents currently in development for NASH, supporting our view that VK2809 has a best-in-class profile. Based on published data from multiple studies, we anticipate that these liver fat reductions would result in longer-term histologic benefit. In addition, the improvement in lipid parameters observed in this study suggests potential benefits in cardiovascular health, an important consideration in this population. We look forward to pursuing further development of VK2809 in NASH.”

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