Viking Therapeutics VKTX announced that it has started the phase II VENTURE-Oral Dosing study to evaluate the safety and efficacy of the oral version of its investigational obesity drug VK2735.
This study's primary endpoint is the percent change in body weight from baseline after 13 weeks of treatment. Management plans to enroll around 280 adults who are either obese or overweight and have at least one weight-related co-morbid condition. These patients will be evenly randomized to one of the six dosing arms of the drug or placebo.
The study initiation is supported by data from a phase I study, which showed that patients who were administered the drug lost up to 8.2% of theirbody weight after 28 days of daily dosing compared with 1.4% in the placebo group. All patients who took the highest drug dose lost at least 5% of their body weight.
Based on a preliminary evaluation of the above results, Viking believes that extending the treatment duration for oral VK2735 beyond 28 days may provide further reductions in body weight.
VKTX Provides Update on Injectable Version of Obesity Drug
Alongside the above news, Viking Therapeutics also announced that it plans to start a late-stage study on the subcutaneous (SC) formulation of VK2735 by the first half of 2025.
The company’s plans to start this late-stage study are supported by data from the phase II VENTURE study, which evaluated once-weekly VK2735 SC for 13 weeks. The study met its primary and all secondary endpoints with statistical significance. Treatment with the SC version achieved statistically significant reductions in mean body weight, ranging up to 14.7%.
VKTX Stock’s Performance
Viking’s shares have surged over 88% in the past year against the industry’s 15% decline.
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Stiff Competition in the Obesity Space
The obesity market has garnered much interest lately, with two companies, Eli Lilly LLY and Novo Nordisk NVO, dominating this space with their respective obesity drugs Zepbound and Wegovy. Per a research conducted by Goldman Sachs, the obesity market in the United States is expected to reach $100 billion by 2030. This is also evident from the fact that Lilly and Novo are investing heavily to optimize their production capacities and have started evaluating multiple other novel obesity candidates.
Anticipating the huge demand for obesity drugs, several companies, such as Roche RHHBY, Amgen and Merck, are also developing their respective drugs and making rapid progress in the space.
Roche forayed into the obesity market after it acquired privately owned Carmot Therapeutics for $2.7 billion last year. The acquisition gave Roche access to Carmot’s differentiated portfolio of incretins, including its lead assets — CT-388, CT-996 and CT-868. A dual GLP-1/GIP receptor agonist, CT-388 is being evaluated for the treatment of obesity in patients with and without type 2 diabetes, injected subcutaneously once a week.
In November, Amgen announced 52-week top-line data from a phase II study on MariTide, its GLP-1 therapy for obesity. The data showed that the drug led to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. Amgen plans to conduct a broad phase III program on MariTide across obesity, obesity-related conditions and type-II diabetes.
The latest entrant in the obesity space is Merck, which recently secured a licensing deal for an investigational oral weight-loss drug developed by China-based Hansoh Pharma.
Viking Therapeutics, Inc. Price
Viking Therapeutics, Inc. price | Viking Therapeutics, Inc. Quote
VKTX’s Zacks Rank
Viking Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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