What's Happening?
Viking Therapeutics, Inc., a clinical-stage biopharmaceutical company, has announced the initiation of its VANQUISH Phase 3 program, which includes two studies evaluating the drug VK2735. These studies target adults with obesity and obese or overweight
adults with type 2 diabetes. The trials aim to assess the efficacy and safety of VK2735, administered by subcutaneous injection once weekly for 78 weeks. The company has not generated any revenue to date and does not expect to receive any until regulatory approval and commercialization of its drug candidates. Viking Therapeutics has also reported significant reductions in mean body weight in its Phase 2 VENTURE study, with reductions up to 14.7% from baseline.
Why It's Important?
The initiation of Phase 3 trials for VK2735 is a critical step for Viking Therapeutics in advancing its drug development pipeline. Successful trials could lead to regulatory approval, providing a new treatment option for obesity and type 2 diabetes, conditions affecting millions of Americans. The potential approval and commercialization of VK2735 could significantly impact the biopharmaceutical industry, offering a novel therapeutic approach to metabolic disorders. This development also highlights the ongoing investment in research and development within the sector, despite the company's current lack of revenue.
What's Next?
Viking Therapeutics plans to file an investigational new drug application for its DACRA program for obesity treatment in the fourth quarter of 2025. The company continues to focus on advancing its VK2735, VK2809, and VK0214 programs, with increased research and development expenses expected as these programs progress. The outcome of the Phase 3 trials will be pivotal in determining the future commercial viability of VK2735.
