Viking Therapeutics to Present New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The Digital International Liver Congress™ 2020
Oral Presentation to Highlight New Efficacy Data Measured at Week 16 and Additional Week 12 Efficacy Data Stratified by Baseline Characteristics and Risk Factors
SAN DIEGO, Aug. 20, 2020 /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 data from the company's 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) will be presented at the Digital International Liver Congress™ 2020. The study results will be featured in an oral presentation at the annual meeting of the European Association for the Study of the Liver (EASL), being held virtually August 27-29, 2020.
As previously reported, the Phase 2 study of VK2089, Viking's novel liver-selective thyroid receptor beta agonist, successfully achieved both its primary and secondary efficacy endpoints, demonstrating median relative reductions in liver fat ranging from 53.8% to approximately 60%, and response rates of up to 100%, both of which represent unprecedented efficacy from an oral agent. The Digital International Liver Congress presentation will include new efficacy data measured at Week 16, four weeks following the completion of treatment. Additional new data will be reported on 12-week efficacy results stratified by baseline patient characteristics and known disease risk factors.
Details of the presentation are as follows:
VK2809, a Novel Liver-Directed Thyroid Receptor Agonist, Produces Durable Reductions in Liver Fat in Patients with Non-Alcoholic Fatty Liver Disease: Results of 4-Week Follow-Up Assessment from a 12-Week Phase 2 Randomized, Placebo-Controlled Trial
Presentation Number: AS073
Date/time: Friday, August 28, 2020, 6:00 – 6:15 a.m. EST
Session: NAFLD – Pharmacological Therapy
Presenter: Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center, and Professor of Medicine, University of California at San Diego
Viking is currently evaluating VK2809 in the Phase 2b VOYAGE study in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis.
VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. In 2019, the company initiated the Phase 2b VOYAGE trial. This trial is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3. The study is targeting enrollment of approximately 340 patients across five treatment arms: 1.0 mg daily; 2.5 mg daily; 5.0 mg every other day; 10.0 mg every other day; and placebo.
The primary endpoint of the study will evaluate the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809, as compared to placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing. U.S. enrollment is continuing and we remain on schedule to begin opening ex-U.S. sites during the third quarter of 2020.
About Viking Therapeutics, Inc.
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking'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 novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, which is currently being evaluated in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company is also developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD).
Viking's other programs include 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 with patients who received placebo. Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.
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.