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Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company, announced the initiation of patient dosing in phase 3 clinical trials of ecnoglutide (XW003) in adult patients with type 2 diabetes in China. Ecnoglutide is a novel, long-acting glucagon-like peptide-1 (GLP-1) analog optimized for improved biological activity, cost-effective manufacturing, and once-weekly dosing. It was shown to be safe and well tolerated, as well as to result in robust HbA1c and weight reductions in phase 2 clinical trials.
The first phase 3 trial (NCT05680155) of the pivotal study is a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of once-weekly subcutaneous administration of ecnoglutide in approximately 210 treatment-naïve patients with type 2 diabetes. Participants in the trial, which is being conducted at approximately 35 sites in China, will be treated with study drug for up to 52 weeks, followed by a 5-week follow-up period. The second phase 3 trial (NCT05680129) is a multicenter, open-label, randomized study to evaluate the efficacy and safety of XW003 versus dulaglutide in patients with type 2 diabetes whose diseases have not been adequately controlled with metformin therapy. Participants in the trial will receive ecnoglutide or dulaglutide for 52 weeks followed by a 5-week follow-up period. Up to 600 participants will be enrolled in this study at approximately 60 sites in China.
"With positive results from phase 2 clinical studies and favourable feedback from the National Medical Products Administration (NMPA) of China, we are very pleased to initiate the phase 3 pivotal trials of ecnoglutide in patients with type 2 diabetes, a critical step towards our goal of delivering safe and effective new treatment to millions of patients with type 2 diabetes in China," said Dr. Hai Pan, founder and CEO of Sciwind. "In addition to the on-going trials in type 2 diabetes, we are also on track to initiate the pivotal study of ecnoglutide in patients with obesity shortly. We look forward to sharing the top-line results from these phase 3 studies in the near future."
Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. Ecnoglutide (XW003) is a novel, biased long-acting GLP-1 peptide analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. Ecnoglutide has demonstrated treatment benefits for patients with type 2 diabetes and obesity and is safe and well tolerated in phase 1 and phase 2 clinical studies.
Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease.
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