Viking Therapeutics announced Tuesday morning new data from a Phase 2b trial looking at its NASH drug, aiming to provide a fuller picture of the results before beginning a pivotal study.
The biotech touted one-year histologic data for its VK2809 program, saying between 63% and 75% of patients across dosing arms saw at least one stage improvement in fibrosis without worsening of NASH, compared to 29% in the placebo group. Additionally, 69% of all patients achieved NASH resolution with no worsening of fibrosis, Viking said ahead of the EASL International Liver Congress that kicks off Wednesday.
Both measures were key secondary endpoints in a Phase 2b trial that read out positive topline data in May 2023 and, according to Tuesday’s data, both were statistically significant with p-values of p<0.05 and p=0.0001, respectively.
The company expects to meet with the FDA in the second half of this year to discuss a potential Phase 3 trial design and timing. The FDA approval for Madrigal’s Rezdiffra in March was based on positive Phase 3 data on NASH (also called MASH) resolution and fibrosis reduction.
Viking has not selected a dose to move into Phase 3 studies yet, CEO Brian Lian said on an investor call, reiterating that the “best outcome” will be finding a large partner with which to run those trials.
“We believe these data clearly demonstrate VK2809’s best-in-class efficacy on both NASH resolution and fibrosis improvement,” Lian added.
Other secondary endpoints presented Tuesday included improvement in patients’ fibrosis with no worsening of NASH, with Viking touting an improvement range of 44% to 57% compared with 34% for placebo. In another secondary endpoint of proportion of participants who saw both fibrosis improve and their disease resolve, the company reported a 40% to 50% range compared to 20% in the placebo group.
Researchers did not see a dose response, Lian said, given the lowest dose tested also enrolled the fewest number of patients. However, higher degrees of statistical significance were generally seen at higher dose levels across these endpoints, and some of the low doses recorded p-values higher than p=0.05.
Lian noted that seeing any improvement in fibrosis without NASH worsening can be considered a success (the 5 mg and 10 mg doses achieved statistical significance; p=0.0304 and p=0.0497).
Tuesday’s additional data included one-year follow-ups of liver fat and plasma lipid reductions, which Viking said were maintained after initial results were previously reported. Viking shares $VKTX were down about 9% in early Tuesday trading.