VK2809



NAME OF DRUG : VK2809

ALSO KNOWN AS : VK2809

LABORATORY : VIKING

STATUS AND ADVANCEMENT

Type of drug : THR-? Agonist prodrug

Clinical trials advancement : Analysing Results Phase 2a

Estimated time to market : 95 months.

LABORATORY ABSTRACT ON THE DRUG

 

Full Data Set for VK2809 in Diet-Induced NASH Model Presented at AASLD

On October 24, 2017, Viking Therapeutics, Inc. (VKTX) announced the presentation of results from a study of VK2809 in an in vivo model of non-alcoholic steatohepatitis (NASH). Statistically significant improvements in a number of key measures were seen during the study and gene expression analysis showed statistically significant changes in expression for genes associated with the development and progression of NASH.

Male wild-type C57BL/6J mice were maintained on a high fat diet for 37 weeks prior to initiation of the study. Liver biopsies were performed and the mice were stratified according to steatosis score and fibrosis stage. Treatment with once daily vehicle control, 30 mg/kg elafibranor (active control), or 10 mg/kg VK2809 continued for eight weeks while continuing the high fat diet. At the end of the study, plasma and liver lipids, liver steatosis, collagen, fibrosis, and hydroxyproline content as well as NAFLD activity score (NAS) were all evaluated. RNAseq analysis was performed on liver samples. An outline of the study is provided below.

 

Similar to what was seen in previous studies of VK2809, there was a significant decrease in plasma triglycerides (- 50%) and plasma cholesterol (-73%) for mice treated with VK2809 compared to vehicle control. There was also a statistically significant decrease in plasma cholesterol for mice treated with VK2809 compared to elafibranor. There was no significant difference in plasma ALT levels for VK2809-treated mice

 

In addition, levels of liver triglycerides (-70%), liver total cholesterol (-65%) and liver total lipid content (-80%) were all significantly lower in mice treated with VK2809 compared to vehicle control mice. The difference in liver triglycerides and liver cholesterol was also significant between VK2809- and elafibranor-treated mice.

 

There was 50% less liver fibrosis in VK2809-treated mice compared to vehicle control-treated mice, as assessed by quantitative histological assessment of picrosirius red stain. The following figures show the level of fibrosis (red areas) in liver sections after eight weeks of treatment.

 

Lastly, the changes seen in lipid content and fibrosis translated to improvements in the NAFLD Activity Score (NAS) for mice treated with both VK2809 and elafibranor.

 

RECENT NEWS ON VK2809

2018-09-18 : Viking Therapeutics Announces Positive Top-Line Results from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol

2017-10-24 : Viking Therapeutics Presents Results from In Vivo Study of VK2809 in Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH) at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)

2017-10-24 : VKTX: Poster Presentations on VK2809 and VK0214 Highlight Positive Preclinical Data for Both Compounds...vs ELAFIBRANOR

2017-09-11 : Viking Therapeutics Announces Results of Gene Expression Analysis from In Vivo Study of VK2809 in Non-Alcoholic Steatohepatitis (NASH)

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