Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Range of VK2809 Doses for up to 52 Weeks
SAN DIEGO, Nov. 19, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of a Phase 2b clinical trial of VK2809, its novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). Clinical trial sites are open for patient enrollment following clearance of the company's Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA).
The VOYAGE study is a randomized, double-blind, placebo-controlled, multicenter trial designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3. Patients with certain comorbid conditions such as type 2 diabetes, as well as patients receiving certain lipid-lowing medications, including statins, are eligible for enrollment. The study will target enrollment of approximately 340 patients across five treatment arms: VK2809 1.0 mg daily; VK2809 2.5 mg daily; VK2809 5.0 mg every other day; VK2809 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. The trial has received clearance for the first six months of dosing and, subject to submission and satisfactory regulatory review of data from recently completed 12-month toxicity studies, patients will continue to receive VK2809 for the planned 52-week treatment duration.
"We are excited to advance VK2809 into the next stage of development and look forward to assessing its safety and efficacy in this important trial. The initiation of the VOYAGE study represents the culmination of significant effort by the Viking team, including the successful execution of several key clinical and non-clinical studies to support a new IND, which was recently filed with the FDA's Division of Gastrointestinal and Inborn Errors Products," stated Brian Lian, Ph.D., chief executive officer of Viking. "We believe the results from our previously announced 12-week Phase 2 trial in subjects with hypercholesterolemia and NAFLD provide a compelling proof-of-concept signal that we intend to further explore in this study. Given the high unmet need for new therapies to treat NASH, and VK2809's promising initial data on both liver fat and plasma lipids, we plan to move forward as quickly as possible to demonstrate the drug's potential benefit in this setting."
VK2809 has been evaluated in six completed clinical studies, which enrolled more than 260 subjects. To date, no serious adverse events (SAEs) have been observed in subjects receiving VK2809, and overall tolerability remains encouraging. In addition, the compound has been evaluated in chronic toxicity studies of up to 12 months in duration.
The IND for the VOYAGE study included results from the previously reported 12-week Phase 2 study of VK2809 in subjects with hypercholesterolemia and NAFLD, as well as prior Phase 1 single and multiple-ascending dose studies in healthy volunteers and subjects with mild hypercholesterolemia, respectively. The filing also included results from additional clinical and non-clinical studies.
New studies submitted with the IND, not previously reported, include:
- VK2809-106: A Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of VK2809 when co-administered with atorvastatin. These data confirmed previously reported results demonstrating no meaningful interaction between VK2809 and atorvastatin when co-administered.
- VK2809-105: A Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of VK2809 dosed in an every-other-day (QOD) regimen. These data confirmed previously reported results demonstrating that VK2809 possesses a predictable and consistent PK profile.
- VK2809-103: A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VK2809 in various dosing regimens. These data demonstrated that various alternative dosing regimens may also produce improvement in measures of plasma lipids.
- 26-Week GLP chronic toxicity studies of VK2809 in primates and rodents, as well as a separate four-week GLP toxicity study of VK2809 co-administered with atorvastatin in primates.
The results of the completed VK2809 studies form the basis for enrollment of the intended target population in the VOYAGE study. Select data from these studies may be submitted for presentation at future scientific conferences.
Viking previously announced positive results from a 12-week Phase 2 trial of VK2809 in patients with hypercholesterolemia and NAFLD, which achieved both its primary and secondary endpoints, demonstrating potent reductions in liver fat content and plasma lipids. Key results from the Phase 2 trial data showed that 88% of patients receiving VK2809 experienced ≥ 30% reduction in liver fat content at 12 weeks, including all patients receiving 5 mg daily doses. In addition, patients receiving VK2809 experienced improvements in low-density lipoprotein cholesterol (LDL-C), triglycerides and atherogenic proteins. VK2809 was shown to be safe and well tolerated in this study, with no SAEs reported in any cohort.
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 is currently being evaluated in a Phase 2b clinical trial in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). VK2809 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 compound 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 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, including NASH. In a Phase 2 trial for the treatment of 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.
Follow Viking on Twitter @Viking_VKTX.
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 VK2809 and VK0214; 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, 2018, 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.
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