Viking Therapeutics initiates VOYAGE study for VK2809 in NASH
Viking Therapeutics has initiated the VOYAGE study, a phase 2b clinical trial of its liver-selective thyroid hormone receptor beta agonist VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH).
The California-based biopharma company said that clinical trial sites have been opened for enrolling patients after it got clearance of investigational new drug (IND) application for the NASH drug candidate from the United States Food and Drug Administration (FDA).
Designed as a randomized, double-blind, placebo-controlled, multicenter trial, the VOYAGE study will evaluate the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3.
Viking Therapeutics said that patients having certain comorbid conditions like type 2 diabetes, and also patients subjected to certain lipid-lowing drugs, including statins, are eligible for enrollment in the VOYAGE clinical trial.
The mid-stage clinical trial is aiming to enroll nearly 340 patients across five treatment arms.
The primary endpoint of the VOYAGE clinical trial will assess the relative change in liver fat content, on the basis of magnetic resonance imaging, proton density fat fraction (MRI-PDFF), from baseline to Week 12 in NASH patients treated with VK2809 in comparison to placebo. Secondary endpoints include assessment of histologic changes on the basis of hepatic biopsy after 52 weeks of dosing.
Brian Lian – CEO of Viking Therapeutics said: “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.
“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 assessed in six completed clinical studies that enrolled a total of more than 260 patients and till date, no serious adverse events have been observed in subjects receiving the liver-selective thyroid hormone receptor beta agonist, while overall tolerability has been encouraging.