Viking speeds up obesity drug timeline, targets monthly dosing

Viking Therapeutics has unveiled plans to expedite the development of its weight loss drug candidate, VK2735, advancing directly into Phase III trials and skipping the previously anticipated Phase IIb study. This unexpected decision, along with the potential for monthly dosing, led to a 28% surge in Viking's stock on Thursday.

VK2735 is a dual GLP-1/GIP receptor agonist. The decision to fast-track its development follows promising mid-stage results from the VENTURE study, which showed a significant reduction in body weight—up to 14.7% from baseline after 13 weeks. This swift progression places Viking in a competitive position within the GLP-1 drug market, which is currently dominated by Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Zepbound (tirzepatide).

Brian Lian, Viking's chief executive, highlighted the company's strong momentum in pipeline programs during the first half of 2024 in a release announcing the company's second-quarter results. Following written feedback from an FDA Type C meeting, Lian confirmed that VK2735 is moving into Phase III development. Viking is preparing for an end-of-Phase II meeting with the FDA, expected to occur later this year. According to BTIG analyst Justin Zelin, this decision is likely to shorten the development timeline for the injection by a year, with analysts predicting the drug might launch in 2029.

In addition to accelerating its timeline, Viking plans to explore monthly dosing for VK2735, potentially offering a significant advantage over Wegovy and Zepound, which require weekly doses. Lian mentioned that Viking expects to test VK2735 as a monthly injection in a future study. Maxim Group analyst Naz Rahman commented that VK2735 could be a best-in-class injectable compound, and a once-monthly formulation could be a significant differentiator for Viking, as patients often struggle with compliance on weekly therapies. Reducing the administration burden to once a month might be highly appealing.

Further complementing its injectable VK2735, Viking is also working on an oral tablet form. Early results from a Phase I study showed promising safety, tolerability, and clinical activity, with participants experiencing a mean weight loss of up to 5.3% from baseline after 28 days of daily oral dosing. Lian stated that dose escalation continues, and a Phase II trial for this program is expected to commence later this year.

Viking's updates made waves in the obesity drug market, leading to declines of 2.8% and 4.5% in shares of market leaders Novo Nordisk and Eli Lilly, respectively.