Viking Therapeutics is stepping on the gas with its experimental GLP-1/GIP receptor agonist for obesity, forgoing a Phase 2b study and jumping right into Phase 3, the company announced.
Viking declined to provide much more detail on its Phase 3 plans, other than saying on a call with investors Wednesday that it expects to have an end-of-Phase 2 meeting with the FDA later this year.
“We’re just not in a position to outline trial design at this point,” CEO Brian Lian said on the call, which was part of the drug developer’s second-quarter earnings results. The company also said it plans to “explore” less frequent dosing intervals, including monthly.
If it reaches the market, Viking’s drug could be a rival to Eli Lilly’s obesity drug Zepbound and Novo Nordisk’s Wegovy. But the race to join those two blockbusters is getting crowded, with multiple companies reporting promising mid-stage and early results, and other large drugmakers talking up plans to either develop or buy their way into the space.
Viking’s stock $VKTX was up 18% in after-hours trading on Wednesday.
In February, Viking unveiled positive topline results for the program, dubbed VK2735. Among 176 patients, those taking subcutaneous VK2735 once a week lost up to 14.7% in mean body weight over 13 weeks, compared to just 1.7% on placebo. Lian said in February that a Phase 2b trial would “more than likely” be the next step, but the company said Wednesday that it’s instead proceeding to Phase 3 based on feedback from the FDA.
Viking is also working on an oral version of VK2735, which is expected to enter Phase 2 in the fourth quarter of this year. Lian said on the call that Viking has enough drug supply on hand to meet “really all of our planned clinical trials, with both the sub-Q and the oral.”
Editor’s note: This story has been updated with a comment from the company about looking at monthly dosing in a future study.