Viking Therapeutics has unveiled the final results of its phase 2b VOYAGE trial of oral small molecule VK2809 in metabolic dysfunction associated steatohepatitis (MASH). At the 52-week mark, the drug reduced liver fat content by an average of 37% to 55% compared to baseline, with all treatment arms showing statistically significant improvements compared to placebo.
The company presented the results in an oral late-breaker presentation at the annual meeting of the American Association for the Study of Liver Disease in San Diego on Nov. 19.
The drug had already hit its primary endpoint of change in liver fat content from baseline at week 12.
Patients in the treatment arms received 1 mg, 2.5 mg, 5 mg or 10 mg doses. After 52 weeks of treatment, patients taking the highest two doses saw their liver fibrosis improve by 44% to 57%, compared to 34% for the placebo group.
Safety results at 52 weeks were similar to data previously reported at 12 weeks, Viking said in a Nov. 19 release about the presentation. Rates of nausea, diarrhea, stool frequency and vomiting were similar among patients receiving VK2809 and placebo, with 94% of treatment-related adverse events being mild or moderate, the company said.
“VK2809 demonstrated significant fibrosis benefit over placebo, despite being underpowered, which in our view underscores the magnitude of the drug’s antifibrotic efficacy,” analysts from William Blair wrote in a Nov. 20 report. “We believe our thesis that VK2809 is the best-in-class MASH drug within the oral modality is affirmed.”
The biopharma industry spent years trying unsuccessfully to develop MASH drugs before Madrigal Pharmaceuticals broke into the space earlier this year with its FDA-approved Rezdiffra. Even as Rezdiffra's launch quickly gains steam, other contenders such as Viking are in the hunt for a piece of what's expected to be a large commercial market.