Viking Therapeutics Announces VK2809 Phase 2 Study Results Selected for Oral Late-Breaker Presentation at The Liver Meeting® 2018

Presentation to Highlight Positive 12-Week Data for Novel, Liver-Selective Thyroid Receptor Beta Agonist in Patients with Non-Alcoholic Fatty Liver Disease and Elevated LDL-Cholesterol

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Viking Therapeutics, Inc.

Oct 04, 2018, 07:02 ET

SAN DIEGO, Oct. 4, 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 the results from the company's Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) have been selected for presentation as part of the oral late-breaker session of The Liver Meeting^® 2018. The presentation will highlight data from the recently completed Phase 2 clinical trial of VK2809. The Liver Meeting 2018, which is the annual meeting of the American Association for the Study of Liver Diseases (AASLD), is being held November 9 – 13 in San Francisco, CA.

Details of Viking's scheduled presentation are as follows:

Title: VK2809, a Novel Liver-Directed Thyroid Receptor Beta Agonist, Significantly Reduces Liver Fat in Patients with Non-Alcoholic Fatty Liver Disease: A Phase 2 Randomized, Placebo-Controlled Trial
Publication Number: lLB-4
Presentation Type: Oral Late-Breaker
Presenter: Rohit Loomba, MD, MHSc
Session: Late-breaking Abstract Oral Session I
Session Date/Time: Monday, November 12, 2018, 3:00 PM
Presentation Time: 3:45 pm Pacific
Presentation Location: Hall D - General Session, Moscone Center, North and South Buildings

VK2809, Viking's lead development program, is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TRβ) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL-C and NAFLD.

As previously reported, the top-line data from this study showed that the trial successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in LDL-C compared with placebo. In addition, the trial's secondary endpoint was achieved, with VK2809-treated patients experiencing statistically significant reductions in liver fat content compared with placebo, and a majority experiencing ≥50% reductions. VK2809 also demonstrated encouraging safety and tolerability in this study, with no serious adverse events reported among patients receiving VK2809 or placebo.

"We look forward to sharing the results of our recently completed Phase 2 trial of VK2809 as part of the oral late-breaker session at The Liver Meeting," stated Brian Lian, Ph.D., Viking's chief executive officer. "The observed effects on liver fat and plasma lipids in this study highlight the promise of VK2809 as a potentially best-in-class thyroid beta agonist for treating fatty liver diseases, including NAFLD and non-alcoholic steatohepatitis (NASH)."

About VK2809
VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TRβ) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The compound successfully achieved primary and secondary endpoints in a Phase 2 study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). The company is also preparing to evaluate VK2809 in a Phase 1 study for the treatment of patients with GSD Ia. 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 genes associated with lipid metabolism and clearance.

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. The company's clinical programs include VK2809, a small molecule thyroid beta agonist. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content. VK2809 was shown to be safe and well-tolerated in the study. The company's second clinical program is VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared to patients who received placebo. The company is also developing VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes. Additional programs include novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia. Viking holds exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.

Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK2809 and its prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely 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, including those for VK5211 and VK2809; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2017, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.

SOURCE Viking Therapeutics, Inc.