Viking Therapeutics shares soared by more than 30% early Thursday after the company told investors it’s moving an experimental obesity drug into Phase 3 testing earlier than expected and exploring more convenient dosing.
The medicine, dubbed VK2735, has already shown promising results in a Phase 2 trial released in February. In that study, patients lost as much as 15% of their body weight after 13 weeks of treatment with the drug, findings that suggest Viking’s option might be a future threat to blockbuster obesity medications sold by Novo Nordisk and Eli Lilly.
Analysts expected the next step would be a Phase 2b trial. But late Wednesday, Viking said it’s moving directly to Phase 3 after a meeting with Food and Drug Administration officials. The company also plans to study monthly injections for the medicine, potentially offering another advantage over the once-weekly products available now.
“The flexibility afforded by offering both a weekly and a monthly regimen should provide an attractive option for patients who wish to tailor dosing to their individual lifestyle and preference,” Viking president and CEO Brian Lian told analysts and investors on a conference call Wednesday. A tablet formulation of the medicine has also shown promise in an earlier study, he noted.
The San Diego-based biotech is vying to enter a market that’s exploded over the last couple years with the introduction of Novo’s Wegovy and Lilly’s Zepbound. There are plenty of rivals racing to introduce their own options as well, including Amgen, Roche, Boehringer Ingelheim, Zealand Pharma, Pfizer and Structure Therapeutics.
Given the competition, Viking’s management deserves credit for developing VK2735 at a “torrid pace,” William Blair analyst Andy Hsieh wrote in a Thursday note to clients. It’s now likely that the company will kick off a Phase 3 trial in early 2025, just about three years after starting Phase 1, he wrote.
Viking expects to give investors more information about the Phase 3 trial after another meeting with the FDA later this year. The company also plans to start a 13-week Phase 2 trial of the tablet form of VK2735 in the fourth quarter.
With promising obesity research and a number of other products in the pipeline, analysts see Viking as an attractive partner for a big pharmaceutical company or even as a potential takeover target. Lian told analysts on the conference call that he had nothing new to share on discussions about potential collaborations.
“We’ve been consistent with our receptivity to interests and opportunities and we remain so,” Lian said. “In the meantime, we are well capitalized and focused on execution of the development programs.”
