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Viking Therapeutics Announces Initiation of Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)
SAN DIEGO, Nov. 19, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the
About this update from Viking Therapeutics, Inc.
[{"type":"text","content":"SAN DIEGO, Nov. 19, 2019 /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 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).\n\n \nThe 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.\nThe 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.\n\"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, P...