Sciwind Biosciences Announces Initiation of Patient Dosing in Phase 3 Clinical Trials of Ecnoglutide (XW003), a Long-acting GLP-1 analog, for the Treatment of T
Sciwind Biosciences, a biopharmaceutical firm specializing in metabolic disease therapies, has started administering ecnoglutide (XW003) to adult patients with type 2 diabetes in China as part of its Phase 3 clinical trials. Ecnoglutide is a new, long-acting GLP-1 analog designed for optimal biological function, cost-efficient production, and weekly dosing. In previous Phase 2 trials, the drug was proven safe and well-tolerated while also achieving significant reductions in HbA1c levels and weight.
The pivotal study's first Phase 3 trial, NCT05680155, is a double-blind, randomized, placebo-controlled trial at 35 sites in China to assess the efficacy and safety of ecnoglutide's once-weekly subcutaneous administration in approximately 210 type 2 diabetes patients who have not received previous treatment. Participants will receive the study drug for up to 52 weeks followed by a 5-week follow-up. The second Phase 3 trial, NCT05680129, is a multicenter, open-label, randomized study comparing ecnoglutide (XW003) to dulaglutide in type 2 diabetes patients whose disease is not controlled by metformin therapy. The trial will last 52 weeks with a 5-week follow-up and enroll up to 600 participants at 60 sites in China.
"With positive results from Phase 2 clinical studies and favorable 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."
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