Late Breaking Poster Presentation Reports New Results Demonstrating Robust Liver Fat Reductions Across Key Subgroups, Including Patients with Type 2 Diabetes and Among Those with F2 or F3 Fibrosis
Presentation also Highlights Previously Reported Results Showing Successful Achievement of Study's Primary Endpoint, Statistically Significant Liver Fat Reductions from Baseline to Week 12 Among Patients Receiving VK2809
52-Week Biopsy Results Expected 1H 2024
SAN DIEGO, Nov. 13, 2023 /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 presentation of new results from the ongoing Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). The latest findings from the VOYAGE study were featured in a late breaking poster presentation at the Liver Meeting® 2023, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is being held November 10-14, 2023, in Boston.
As previously reported, the VOYAGE 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. Newly reported findings demonstrated robust and comparable liver fat reductions among patients with or without type 2 diabetes, as well as patients with either F2 or F3 fibrosis. These data demonstrate that VK2809's potential therapeutic activity is not meaningfully impacted by the presence of type 2 diabetes or by patients' stage of fibrosis. The data are important as the presence of liver fat and associated lipotoxicity are believed to play a contributing role in the onset and progression of NASH.
Highlights from the AASLD presentation 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 magnetic resonance imaging, proton density fat fraction (MRI-PDFF) relative to placebo after 12 weeks of treatment. The median relative reduction from baseline in liver fat ranged from 38% to 55% for patients receiving VK2809. 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 a 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 |