With promising Phase II data in hand, Viking Therapeutics is pushing its subcutaneous GLP-1/GIP receptor dual agonist into late-stage development, the company announced on Wednesday.
Viking Therapeutics announced on Wednesday that it will accelerate the development of its investigational subcutaneous GLP-1/GIP receptor dual agonist VK2735 for obesity, with an eye towards starting Phase III development in the coming months.
The decision to push VK2735 into late-stage studies follows promising findings from the Phase II VENTURE study, which showed that the candidate could safely and substantially reduce body weight in overweight or obese patients with at least one related comorbidity.
Viking posted topline data from VENTURE in February 2024, touting 9.1% weight loss at the 2.5-mg dose level. Patients who were given the 15-mg dose saw a 14.7% drop in body weight. Compared with placebo, which cut weight by only 1.7%, the treatment effect of both VK2735 doses was statistically significant.
The company said on Wednesday that this weight loss was durable, if not progressive, through 13 weeks of treatment “and did not show evidence of plateauing.”
VENTURE also found VK2735 to be safe, with most adverse events being mild or moderate in severity. Dropouts due to treatment toxicities were well-balanced between the active treatment and placebo arms.
“We are advancing this compound into Phase III development,” CEO Brian Lian said in a statement, noting that Viking has received “written feedback from an FDA Type C meeting” and is currently “preparing for an end of Phase II meeting with the agency, which we expect to occur later this year.” Final Phase III plans, including design and timeline, will be disclosed after the meeting.
William Blair analyst Andy Hsieh in an investor note said that Viking has been pushing VK2735 “at a torrid pace” and that if the company is able to launch a Phase III study for the asset in early 2025, it would have pushed the candidate from early- to late-stage developing in roughly three years.
Still, Hsieh raised concerns about VK2735’s future prospects if it remains with Viking. “Given the unprecedented market opportunity in obesity, we believe that the value of VK2735 will ultimately be maximized in the hands of a big pharma, which could best navigate the rebate/discount-driven reimbursement landscape,” he wrote.
VK2735 is a dual agonist of the GLP-1 and GIP receptors. Activating these pathways has been shown to be an effective method to reduce blood glucose levels and suppress appetite, potentially helping to address type 2 diabetes and lower body weight.
In addition to a subcutaneous formulation, Viking is also developing an oral version of VK2735, which elicited a 3.3% reduction in body weight versus placebo, according to a Phase I readout posted in March 2024. On Wednesday, Viking announced it expects to start the Phase II study for the oral pill in the fourth quarter of 2024.
