Viking Therapeutics to Conduct Phase 2 Trial of VK2809 in Patients With Cholesterolemia and Fatty Liver Disease

SAN DIEGO, July 29, 2015 (GLOBE NEWSWIRE) -- Viking Therapeutics, Inc. ("Viking") (NASDAQ:VKTX), 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."

VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor that is entering Phase 2 development for the treatment of patients with hypercholesterolemia and fatty liver disease.  VK2809 belongs to a family of novel prodrugs which are cleavedin vivoto release potent thyromimetics.  Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression of low-density lipoprotein (LDL) receptors and increasing mitochondrial fatty acid oxidation.

In a Phase 1b clinical trial, VK2809 demonstrated statistically significant reductions in LDL cholesterol, triglycerides, and certain proteins associated with inflammation and cardiovascular disease.  Furthermore, published preclinical data from multiple animal studies demonstrate that VK2809 significantly reduces liver fat content in models of hepatic steatosis and also possesses additive cholesterol lowering activity in combination with statins.  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 rapidly becoming a leading cause of cirrhosis and liver failure and affects an estimated 6 to 15 million Americans.

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders. The company's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated. The company's clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, entering Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist entering Phase 2 development for cholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Viking is also developing novel and selective agonists of the thyroid beta receptor for adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.

This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking's expectations regarding the company's proposed Phase 2 trial and investigational new drug (IND) application for VK2809, as well as VK2809's potential to produce therapeutic benefits. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements.