Hangzhou-based biopharma Sciwind Biosciences Co., Ltd announced positive results from a 20-week Phase II trial of its XW003 (ecnoglutide) in Chinese adults with type 2 diabetes (T2D). The study demonstrated the drug’s safety, tolerability, and significant HbA1c reductions, meeting primary endpoints.
Study Details
The multi-center, randomized, placebo-controlled trial involved 145 patients with uncontrolled T2D. Subjects received weekly subcutaneous injections of 0.4 mg, 0.8 mg, or 1.2 mg XW003, or placebo for 20 weeks. Baseline mean HbA1c was 8.55%.
Results
At week 20, XW003 achieved dose-dependent HbA1c reductions:
- 0.4 mg: 1.8% reduction (vs. placebo’s 0.5%)
- 0.8 mg: 1.9% reduction
- 1.2 mg: 2.4% reduction (p < 0.0001)
88% of the 1.2 mg cohort reached HbA1c ≤7.0% (vs. 21% on placebo), and 72% achieved HbA1c ≤6.5% (vs. 9% on placebo). XW003 also reduced body weight and improved cardiometabolic markers, including fasting glucose, blood pressure, and liver enzymes. The drug was well-tolerated, with no serious adverse events or hypoglycemia.
Future Plans
XW003, a long-acting GLP-1 analogue, is advancing to Phase III trials for T2D and weight management. It is also in trials for obesity in China and Australia, with results expected soon. The drug is being developed for obesity, T2D, and non-alcoholic steatohepatitis (NASH).-Fineline Info & Tech
