Viking Therapeutics $VKTX has proven once again that nothing whips up biotech investors like positive Phase II numbers for NASH.
The San Diego-based biotech’s shares rocketed up more than 100% Tuesday morning on Viking’s boast that VK2809 slashed liver fat content — a biomarker for the disease — while delivering a drop of 20% or more in LDL in the mid-stage study.
Jefferies’ Michael Yee looked it over and boiled the data down to this: “57-60% median relative change in liver fat by MRI-PDFF including a 77-91% responder rate on >30% fat reduction hurdle; and they looked at ‘super’ responders of >50% fat reduction of which was 61-73% response rate….while cross-trial in non-identical populations, MDGL was a bit lower at 36-42% median relative change and 60-75% achieving the >30% reduction threshold. (2) LDL-cholesterol reduction was ‘greater than 20%’ and in the ballpark of MDGL also 19-21% on an optimal dose of MGL-3196.”
That looks good relative to the pack chasing a big approval for NASH, a blockbuster sized market, notes Yee. But he also advises a little caution before the street loses its head. The caveats: This is a 45-person Phase II, offering little more than a snapshot of the data to come. Yee adds that he believes that the biotech will need to run another Phase II before they move into a late-stage pivotal, and that puts any potential marketing decision years down the road.
He noted: “(D)ata is still early vs peers and has limited safety info and will require another bigger Phase II biopsy study likely before starting any Phase III.”
Viking, though, was staying strictly optimistic about its chances.
“Previous studies by our group have shown that a 30% or greater reduction in MRI-PDFF is associated with higher odds of histologic response in NASH. The quantum of liver fat reduction along with LDL-lowering properties of VK2809 are potentially likely to be beneficial in patients with non-alcoholic steatohepatitis (NASH) who have a significant risk of not only liver fibrosis progression but also cardiovascular disease,” stated Rohit Loomba, a professor at University of California at San Diego.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 34,900+ biopharma pros who read Endpoints News by email every day.Free Subscription