Hangzhou-based Sciwind announced positive interim topline results from a 26-week Phase Ic/IIa clinical study of its drug candidate XW003 (ecnoglutide) in overweight or obese Chinese adult patients.
Study Details
The ongoing multicenter Phase 1c/2a study in China involved 60 non-diabetic overweight or obese adult subjects. Participants were randomized into three cohorts receiving weekly subcutaneous doses of 1.8 mg XW003, 2.4 mg XW003, or placebo.
Positive Results
At the end of 14 weeks of treatment, 72.4% of subjects in the 1.8 mg XW003 cohort and 66.7% in the 2.4 mg XW003 cohort lost more than 5% of their body weight, compared to 20% in the placebo cohort. Additionally, 34.5% in the 1.8 mg XW003 cohort and 28.6% in the 2.4 mg XW003 cohort lost more than 10% of their body weight, compared to 10% in the placebo cohort. Waist circumference, hip circumference, and waist-to-hip ratio were significantly reduced in XW003 subjects, with favorable trends observed in metabolic parameters.
Safety Profile
XW003 was generally safe and well-tolerated, with no treatment-related serious adverse events (SAEs) or grade 3 or higher adverse events. No study drug-related adverse events led to discontinuation.
Drug Development
XW003 is a novel, biased, long-lasting glucagon-like peptide-1 (GLP-1) peptide analogue being developed to treat obesity, T2D, and non-alcoholic steatohepatitis (NASH). The drug has entered clinical trials for T2D, weight management, and NASH in mainland China. It is expected to advance to a pivotal Phase III clinical study in T2D and weight management and is concurrently undergoing clinical trials in obesity in China and Australia, with results anticipated in the near-term.-Fineline Info & Tech
