Viking Therapeutics (VKTX) Announces Dosing of First Patient in VK2809 Phase 2

October 4, 2016 7:07 AM EDT

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Viking Therapeutics, Inc. (Nasdaq: VKTX) announced that the first patient has been dosed in the company's Phase 2 clinical trial of VK2809 in patients with primary hypercholesterolemia and non-alcoholic 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.

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 approximately 80 patients with elevated LDL cholesterol (LDL-C) and non-alcoholic fatty liver disease. Patients will be 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 inflammatory markers.

"We are excited to have this trial underway as it represents an important milestone for both the company and the development of novel treatments for hypercholesterolemia and fatty liver disease. This study will be critical in validating VK2809's unique liver-targeted mechanism of action, which we believe provides differentiated benefits by simultaneously reducing hepatic steatosis, an important driver of non-alcoholic steatohepatitis (NASH), and improving plasma lipid levels," said Brian Lian, Ph.D., chief executive officer of Viking. "Prior data have shown that treatment with VK2809 can lead to rapid histologic improvement in animal models of hepatic steatosis, as well as significant reductions in LDL-C, triglycerides, and atherogenic proteins in humans. Along with our ongoing Phase 2 trial of VK5211 in hip fracture, this trial will provide a second important Phase 2 study readout that we expect will demonstrate the potential value of our pipeline of novel therapies for metabolic and endocrine disorders."

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