Viking Therapeutics, Inc. (VKTX) announced positive 52-week histologic data from its Phase 2b VOYAGE study of VK2809 in patients with non-alcoholic steatohepatitis (NASH).
The study achieved its primary endpoint, with patients receiving VK2809 showing statistically significant reductions in liver fat content from baseline to Week 12 compared to the placebo group.
The recently announced results emphasize secondary endpoints that evaluated histologic changes via hepatic biopsy after 52 weeks of VK2809 treatment.
Notably, up to 75% of patients treated with VK2809 achieved NASH resolution without worsening fibrosis, compared to 29% in the placebo group. Moreover, 57% of VK2809-treated patients showed more than a one-stage improvement in fibrosis with no worsening of NASH, whereas only 34% of the placebo group experienced such improvement. Additionally, 48% of VK2809-treated patients achieved both NASH resolution and greater than one-stage improvement in fibrosis, compared to 20% for the placebo group.
Treatment-related adverse events were consistent with previously reported data at week 12.
