Viking Therapeutics VKTX announced that it has completed enrolling study participants in the phase II VENTURE-Oral Dosing study, which is evaluating the safety and efficacy of the oral formulation of its experimental obesity drug VK2735. Data from this study is expected in the second half of 2025.
This study has enrolled around 280 adults who are either obese or overweight and have at least one weight-related co-morbid condition. These patients have been evenly randomized to one of the six dosing arms of the drug or placebo. The study’s primary endpoint is the percent change in body weight from baseline after 13 weeks of treatment.
In our opinion, this announcement marks a milestone for the company since the study initiation was declared in January. The rapid enrolment in the study suggests strong demand and interest in VK2735. This aligns with the market expansion for weight loss drugs, fueled by the success of Eli Lilly’s LLY Zepbound and Novo Nordisk’s NVO Wegovy. The quick recruitment also indicates high patient and physician enthusiasm, which could translate into significant commercial potential if the drug proves effective and safe.
The study initiation is supported by data from an early-stage study, which showed that patients who received oral VK2735 lost up to 8.2% of theirbody weight after 28 days of daily dosing compared with 1.4% in the placebo group. Based on a preliminary evaluation of these results, Viking believes that extending the treatment duration for the oral drug beyond 28 days may provide further reductions in body weight.
Viking also reiterated its plans to start a late-stage study on the subcutaneous version of VK2735 by the first half of this year.
Year to date, the company’s shares have plunged 36% against the industry’s 1% growth.
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The obesity market has garnered much interest lately, as both Lilly and Novo dominate this space with their respective obesity drugs. 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 LLY and NVO have not only optimized their production capacities but are also developing multiple other novel obesity candidates at a rapid pace.
Anticipating the huge demand for obesity drugs, several companies, such as Roche RHHBY, Amgen, AbbVie and Merck, are developing their respective drugs and making rapid progress in the space.
Roche entered the obesity market after acquiring Carmot Therapeutics for $2.7 billion last year. Post this buyout, it added a differentiated portfolio of incretins to its pipeline, which includes CT-388, CT-996 and CT-868. A dual GLP-1/GIP receptor agonist, CT-388, is being evaluated in a mid-stage study for treating obesity in patients with and without type 2 diabetes (T2D), injected subcutaneously once a week.
Roche is also exploring the potential of obesity drugs beyond its Carmot deal. Earlier this month, RHHBY signed an exclusive collaboration and licensing agreement with Zealand Pharma to develop and market the latter’s amylin analog as a standalone therapy and in a fixed-dose combination with CT-388.
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 T2D.
Some recent entrants in the obesity space include Merck and AbbVie. Both these companies entered this space through a similar route — a licensing deal. While AbbVie forayed into the obesity space after signing a licensing agreement with Denmark-based biotech Gubra for the latter’s experimental obesity drug, Merck secured a licensing deal for an investigational oral weight-loss drug developed by China-based Hansoh Pharma in December.
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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