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Viking Therapeutics Submits Investigational New Drug (IND) Application to Conduct Phase 2 Clinical Trial of VK2809 in Patients with Hypercholesterolemia and Fatty Liver Disease
Date:11/17/2015

SAN DIEGO, Nov. 17, 2015 /PRNewswire/ -- 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 that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 study 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 expects to initiate the Phase 2 clinical trial by the end 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 (LDL-C) and fatty liver disease.  Patients will be randomized to receive once-daily doses of VK2809 or placebo for 12 weeks.  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 will assess changes in liver fat content, triglycerides, and inflammatory markers.  Viking expects to complete the study in 2016.

"We are eager to evaluate the therapeutic impact of VK2809 in patients with hypercholesterolemia and fatty liver disease," said Brian Lian, Ph.D., chief executive officer of Viking.  "Prior human data suggest that treatment with VK2809 leads to significant reductions in LDL-C, triglycerides, and atherogenic proteins.  In addition, animal models of hepatic steatosis have demonstrated compelling reductions of liver fat content following treatment.  VK2809's novel liver-targeted mechanism of action provides a unique opportunity to potentially improve plasma lipid levels and reduce hepatic steatosis simultaneously, which may provide important therapeutic benefits for patients.  Together with our recently-initiated Phase 2 clinical trial of VK5211, our lead program for muscle and bone disorders, the Phase 2 VK2809 study will represent the second key clinical trial we will have underway by year-end.  We believe we are making excellent progress toward our goal of unlocking substantial value from our pipeline programs." 

About VK2809
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 cleaved in vivo to 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 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 suggest a highly differentiated therapeutic profile relative to existing oral options for patients with hypercholesterolemia and fatty liver disease, such as nonalcoholic steatohepatitis (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 rapidly becoming a leading cause of cirrhosis and liver failure and affects an estimated 6 to 15 million Americans. 

About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. 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, in 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 hypercholesterolemia 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.

Forward Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking's expectations regarding the company's proposed Phase 2 clinical 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.

 


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