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Study achieves primary endpoint, demonstrating statistically significant reductions in liver fat from baseline to week 12 in patients receiving VK2809 as compared to placebo
Ligand is entitled to receive a $10 million milestone payment upon initiation of a Phase 3 clinical trial as well as royalties of 3.5% to 7.5% on commercial sales of VK2809, if approved
SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX) today announced positive top-line results from its Phase 2b clinical trial of VK2809, a novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The study successfully achieved its primary endpoint, with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to Week 12 as compared with placebo. The median relative change from baseline in liver fat as assessed by magnetic resonance imaging and proton density fat fraction (MRI-PDFF) ranged from 38% to 55% for patients receiving VK2809. Additionally, VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and atherogenic lipoproteins compared with placebo. Viking expects to submit the results for presentation at a future medical conference.
Under a license agreement with Viking for VK2809, Ligand is entitled to receive a $10 million milestone upon initiation of a Phase 3 clinical trial, other potential milestone payments and royalties of 3.5% to 7.5% on future worldwide sales of VK2809 by Viking.
“We extend our congratulations to the Viking team for the impressive topline results from the VK2809 VOYAGE trial reported today,” said Todd Davis, CEO of Ligand Pharmaceuticals. “VK2809 is an important partnered asset for Ligand, and the increasing evidence of its clinical efficacy in treating NASH is encouraging.”
Top-line study results reported by Viking include:
Primary Endpoint: Reduction in Liver Fat Content at 12 Weeks
Patients receiving VK2809 experienced statistically significant reductions in liver fat content, as assessed by MRI-PDFF, relative to placebo after 12 weeks of treatment. Importantly, up to 85% of patients receiving VK2809 experienced at least a 30% relative reduction in liver fat content, a level of reduction that is associated with greater likelihood of histologic response in NASH.
| Placebo (n = 62) | VK2809 1 mg QD (n = 17)3,4 | VK2809 2.5 mg QD (n = 58) | VK2809 5 mg QOD (n = 36)4 | VK2809 10 mg QOD (n = 56) |
Mean baseline liver fat content | 20.4% | 21.7% | 20.2% | 18.4% | 21.5% |
Mean relative change in liver fat by MRI-PDFF1,2 | -3.7%
| -16.6% (p=0.082) | -45.3% (p |
