Viking Therapeutics announced the final 52-week data from its Phase 2b VOYAGE clinical trial of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as MASH) on November 19, 2024. The oral late breaker presentation at the 75th Liver Meeting 2024 summarized that VK2809 successfully achieved the trial's primary and secondary endpoints.
Patients treated with VK2809 demonstrated NASH resolution ranging from 63% to 75%, compared with 29% for placebo, without worsening of fibrosis. Additionally, improvement in fibrosis without worsening of NASH was observed in 44% to 57% of VK2809-treated patients, compared with 34% for placebo. Up to 50% of patients achieved both NASH resolution and fibrosis improvement, compared to 20% for placebo.
The study also showed statistically significant reductions in liver fat content, ranging from 37% to 55% at Week 52, and placebo-adjusted reductions in LDL-C ranging from 20% to 25%. VK2809 demonstrated encouraging safety and tolerability throughout the 52-week treatment period, with 94% of treatment-related adverse events reported as mild or moderate and low discontinuation rates.
These compelling histological and lipid-lowering results position VK2809 as a potentially best-in-class therapy for NASH/MASH and fibrosis. The data support its therapeutic potential and suggest a long-term cardioprotective effect, which is a valuable benefit in this patient population.
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