Viking Therapeutics' VK2735 Shows Promise in Obesity Treatment, Faces Manufacturing Concerns
核心洞察
Viking Therapeutics' VK2735 demonstrated a placebo-adjusted weight loss of 6.8% in the high-dose cohort after four weeks in a Phase I trial.
The oral drug, a dual GLP-1R (搜索)/GIP receptor (搜索) agonist, is set to begin a 13-week Phase II study in Q4 2024, with potential to compete with Eli Lilly's Mounjaro.
Despite positive data, Viking's stock experienced volatility due to analyst concerns about the costly manufacturing requirements for VK2735.
Viking Therapeutics is making waves in the obesity (搜索) treatment landscape with its experimental drug, VK2735. The company recently announced positive results from a Phase I trial of the oral formulation of VK2735, a dual glucagon-like peptide-1 receptor (GLP-1R (搜索))/gastric inhibitory polypeptide (GIP) receptor agonist, at ObesityWeek 2024 in Texas. The early-stage trial data revealed a placebo-adjusted weight loss of 6.8% in the high-dose cohort after just four weeks of treatment in 92 patients.
The Phase I study (NCT05203237) involved eight different doses of VK2735, ranging from 2.5mg to 100mg, compared to a placebo. The majority of adverse events reported were mild to moderate, with only four patients on VK2735 and two on placebo discontinuing the trial. Viking Therapeutics plans to initiate a 13-week Phase II study of the oral candidate in Q4 2024.
Market Reaction and Analyst Concerns
Following the release of the positive data, Viking Therapeutics' stock initially surged by 7.44%, climbing from a close of $72.88 on November 1 to an opening of $78.30 on November 4. However, the stock later experienced a significant drop of 19.36% after Deutsche Bank analyst James Shin raised concerns about the potential manufacturing challenges associated with VK2735. Shin suggested that the production of the drug could be "costly with capital requirements and expertise" that might exceed the resources of even major competitors, according to Reuters.
Despite these concerns, Viking CEO Brian Lian stated last month that the company is actively engaged in discussions with manufacturers to ensure a robust supply of the drug, aiming for a "blockbuster" launch.
Subcutaneous VK2735 Shows Promising Results
Viking Therapeutics also presented additional data from its Phase II study of a subcutaneous version of VK2735. The 13-week VENTURE study (NCT06068946) demonstrated a mean weight loss of 14.7%, or 13.1% when adjusted for placebo, in the high-dose cohort. Mid-stage data from the VENTURE study, announced in February 2024, had already propelled the company's stock price by 80%, showcasing average weight losses of 9.2kg, 10.7kg, 13.3kg, 14.6kg, and 1.8kg in the 2.5mg, 5mg, 10mg, 15mg, and placebo groups, respectively.
Based on these promising results, Viking Therapeutics is bypassing a Phase IIb trial and moving directly to a Phase III trial after receiving the go-ahead from the US Food and Drug Administration (FDA).
Competition in the Obesity Market
According to GlobalData, both the oral and subcutaneous formulations of VK2735 have the potential to become direct competitors to Eli Lilly's Mounjaro (tirzepatide), which is currently the only approved dual GLP-1/GIP receptor (搜索) agonist. The obesity (搜索) market is currently dominated by glucagon-like peptide 1 receptor agonists (GLP-1ra), with Eli Lilly's tirzepatide and Novo Nordisk's semaglutide leading the way. Semaglutide, marketed as Ozempic for type 2 diabetes (搜索) (T2D) and Wegovy for obesity, is projected to generate $42.85 billion in sales in 2030, according to GlobalData. Eli Lilly's tirzepatide, marketed as Mounjaro for T2D and Zepbound for obesity, is expected to bring in $57.65 billion in the same year.