Viking Therapeutics Completes Enrollment in Phase 2 Study of VK2809 in Patients with Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
SAN DIEGO, June 5, 2018 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that enrollment has been completed in the company's ongoing Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). VK2809 is a novel, orally available small molecule thyroid receptor agonist that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promise in this patient population.
The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL cholesterol (LDL-C) and NAFLD. Patients have been randomized to receive once-daily oral doses of VK2809 or placebo for 12 weeks followed by a four-week off-drug phase. The trial's primary endpoint will evaluate the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. Secondary and exploratory endpoints include assessments of changes in liver fat content, triglycerides, and other lipid markers. Viking expects to announce results from this trial in the second half of 2018.
"We are pleased to have completed patient enrollment in this important study and remain on track to report top-line results during the second half of this year. We believe VK2809's potent activity at the thyroid beta receptor may provide benefit to patients with fatty liver disease, such as non-alcoholic steatohepatitis (NASH)," said Brian Lian, Ph.D., chief executive officer of Viking. "In vivo studies have shown that treatment with VK2809 leads to significant improvement in markers related to NASH development, severity and progression. In addition, prior clinical data in subjects with mild hypercholesterolemia have demonstrated that treatment with VK2809 results in significant reductions in LDL cholesterol, triglycerides and atherogenic proteins."
In a Phase 1b study in patients with mild hypercholesterolemia, treatment with VK2809 resulted in placebo-adjusted reductions in low-density lipoprotein ranging from 15% to 40%. Patients also experienced significant reductions in triglycerides, as well as the atherogenic proteins lipoprotein-a and apolipoprotein B. Consistent with its liver- and receptor-selective mechanism of action, treatment with VK2809 has also demonstrated rapid reduction of liver fat in animal models of hepatic steatosis. Furthermore, results from an in vivo evaluation of VK2809 in a model of diet-induced NASH demonstrated statistically significant reductions in fibrosis, steatosis and the NAFLD activity score (NAS) in animals treated with VK2809 compared with vehicle-treated controls. Gene expression analyses demonstrated significant improvements in genes related to fibrosis, steatosis, insulin sensitivity and metabolic control.
These preclinical and clinical study results suggest a differentiated therapeutic profile for VK2809 relative to existing development programs targeting hypercholesterolemia and fatty liver disease, such as NASH. The potential markets for these indications are significant. In the U.S., approximately 33% of adults, or 71 million people, have elevated LDL cholesterol. Additionally, NASH is becoming recognized as a leading cause of cirrhosis and liver failure and affects an estimated 6 to 15 million Americans.
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SOURCE Viking Therapeutics, Inc.
Company Codes: NASDAQ-SMALL:VKTX