Hangzhou-based Sciwind Biosciences Co., Ltd has announced the first subject dosing in a Phase III clinical study for its ecnoglutide (XW003), a novel, long-acting glucagon-like peptide-1 (GLP-1) analog, in adult patients with type 2 diabetes in China. The trial marks a significant milestone in the development of this innovative therapy, which aims to improve treatment options for patients with metabolic diseases.
Phase III Trial Details
The first Phase III trial (NCT05680155) is a multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of once-weekly subcutaneous administration of ecnoglutide in approximately 210 treatment-naïve patients with type 2 diabetes. Conducted at approximately 35 sites in China, the trial will treat participants with the study drug for up to 52 weeks, followed by a 5-week follow-up period.
The second Phase III trial (NCT05680129) is a multicenter, open-label, randomized study comparing ecnoglutide to dulaglutide in patients with type 2 diabetes inadequately controlled by metformin therapy. Up to 600 participants will be enrolled at approximately 60 sites in China, with treatment lasting 52 weeks followed by a 5-week follow-up period.
Ecnoglutide: Mechanism and Development
GLP-1 analogs are effective therapies for managing type 2 diabetes and obesity and have demonstrated potential in treating non-alcoholic steatohepatitis (NASH). Ecnoglutide (XW003) is a novel, long-acting GLP-1 peptide analog optimized for improved biological activity, cost-effective manufacturing, and once-weekly dosing. The molecule has shown significant treatment benefits in Phase I and Phase II clinical studies for patients with type 2 diabetes and obesity. Sciwind plans to initiate a regulatory study for ecnoglutide in obesity in the near term.
Sciwind’s Pipeline and Future Outlook
Sciwind is a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies for metabolic syndrome. Its pipeline includes potentially first-in-class and best-in-class drug candidates such as ecnoglutide (Phase III), oral GLP-1 peptide analog XW004 (Phase I), and oral small molecule GLP-1 receptor agonist XW014 (Phase I). These developments highlight Sciwind’s commitment to advancing novel treatments for metabolic diseases.-Fineline Info & Tech
