HANGZHOU, China and SAN FRANCISCO, Jan. 30, 2023 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, announced today 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 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."
About ecnoglutide (XW003)
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.
About Sciwind
Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide analog ecnoglutide (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), and oral small molecule GLP-1 receptor agonist XW014 (Phase 1). Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery platforms and identified a series of drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com.
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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.
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"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."
About ecnoglutide (XW003)
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.
About Sciwind
Sciwind Biosciences is a clinical stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease. Its product pipeline consists of potentially first-in-class and best-in-class drug candidates, including the long-acting GLP-1 peptide analog ecnoglutide (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), and oral small molecule GLP-1 receptor agonist XW014 (Phase 1). Sciwind has developed multiple proprietary technologies, including oral peptide and inhaled protein therapeutic delivery platforms and identified a series of drug candidates based on these core platform technologies. For more information, visit www.sciwindbio.com.
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SOURCE Hangzhou Sciwind Biosciences Co., Ltd.
