Viking Therapeutics Reports Will Conduct Phase 2 Trial of VK2809 in Patients with Cholesterolemia, Fatty Liver Disease

Viking Therapeutics, Inc. ("Viking")

, a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, today announced plans to conduct a Phase 2 trial of VK2809 in patients with hypercholesterolemia and fatty liver disease. 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 promising therapeutic potential in this patient population. Viking intends to file an investigational new drug (IND) application and initiate the clinical development program in the fourth quarter of 2015. The planned Phase 2 study will be a randomized, double-blind, parallel group, placebo-controlled trial designed to evaluate the efficacy, safety and tolerability of VK2809 in approximately 100 patients with elevated LDL cholesterol and fatty liver disease. Viking expects to complete the study in 2016. VK2809 has demonstrated an encouraging preliminary efficacy, safety and tolerability profile in previous clinical studies. In a Phase 1b study in patients with mild hypercholesterolemia, treatment with VK2809 resulted in placebo-adjusted reductions in low-density lipoprotein that exceeded 40% at high doses. 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. Further animal data have shown that VK2809 has additive cholesterol lowering activity in combination with statins. These characteristics combine to suggest a highly differentiated therapeutic profile relative to existing oral options for patients with hypercholesterolemia and fatty liver disease, such as nonalcoholic steatohepatitis (NASH). "We look forward to advancing VK2809 into clinical development, as we believe the compound's novel mechanism-of-action and impressive data to date position it as an exciting, first-in-class approach to the dual challenge of hypercholesterolemia and hepatic steatosis," said Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "Importantly, our ability to target the therapeutic activity of the compound specifically to liver tissue presents a unique opportunity to develop a product that simultaneously addresses the large population of patients suffering from both disorders."