San Diego's Viking Therapeutics Inc. said its drug VK2809 significantly reduced liver cholesterol and fat in a mid-stage trial.
The 12-week phase 2 study enrolled patients with non-alcoholic fatty liver disease, or NAFLD, and elevated low-density lipoprotein cholesterol, or LDL-C, also known as bad cholesterol.
NAFLD is associated with increased risk of diabetes, high blood pressure and kidney disease, among others. High levels of LDL-C is associated with increased risk of heart disease and stroke.
Viking Therapeutics evaluated VK2809 against placebo. VK2809-treated patients were dosed either daily, labeled QD, or every other day, labeled QOD.
VK2809 achieved the trial's main goal of delivering statistically significant reductions in LDL-C: 20.2% in the 11 QD patients and 23.6% in the 13 QOD patients. Viking Therapeutics did not provide a number for the 11 placebo-treated patients.
The company also noted statistically significant improvements in other lipids, which suggest potential cardiovascular benefit associated with VK2809 treatment.
A secondary goal of statistically significant reductions in liver fat content was also achieved. The 11 QD patients saw a 59.7% median relative reduction in liver fat, compared to 56.5% in the 13 QOD patients and 8.9% in the 11 placebo-treated patients.
Additionally, VK2809 showed an encouraging safety and tolerability profile, with no serious adverse events reported, the company said. Viking Therapeutics said overall adverse events were evenly distributed across all treatment groups, with a slightly greater incidence among placebo-treated patients, compared to VK2809-treated patients.
Viking Therapeutics presented the data Nov. 12 at the American Association for the Study of Liver Diseases' annual meeting in San Francisco.
The company said it also plans to evaluate VK2809 as a treatment for Glycogen storage disease type Ia, a genetic disorder that impairs organ function.
