XW-014

HANGZHOU, China and SAN FRANCISCO, Sept. 5, 2024 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease, today announced that the company will present positive results from a Phase 3 clinical study of injectable ecnoglutide (XW003) in patients with type II diabetes mellitus and from a Phase 1 study of oral ecnoglutide (XW004) in healthy and healthy obese participants, at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting, to be held in Madrid, Spain, September 9 – 13, 2024. Details of the oral presentations are as follows: Title: A Phase 3 Evaluation of cAMP Signaling Biased GLP-1 Analog Ecnoglutide (XW003) in Adults with Type 2 Diabetes (Presentation #148) Presenter: Susan Xu, MD, PhD Date/Time: Sep 12, 2024, 10:45 AM – 12:15 PM CEST Session: OP 25 (Incretin Receptor Agonists: Better and Better) Title: Phase 1 Topline Safety, Efficacy, and Pharmacokinetics of Oral Ecnoglutide (Presentation #736) Presenter: Mohammed Junaidi, MD Date/Time: Sep 12, 2024, 2:00 PM – 3:00 PM CEST Session: SO 060 (Novel Incretins: It is All about Clinical Outcomes) About Ecnoglutide 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 MASH. Ecnoglutide is a novel, cAMP signaling biased, long-acting glucagon-like peptide-1 (GLP-1) peptide optimized for improved biological activity and cost-effective manufacturing. Ecnoglutide has demonstrated treatment benefits for patients with type 2 diabetes and people with overweight or obesity and is safe and well tolerated in Phase 1 through Phase 3 clinical studies. About Sciwind Biosciences 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 XW003 (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), an oral small molecule GLP-1 receptor agonist XW014 (Phase 1), and novel amylin analogs (preclinical). 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 . SOURCE Hang Zhou Sciwind Biosciences Co., Ltd.

A Phase 1 study of oral ecnoglutide ( 1871-LB) showed it to be safe and well tolerated and result in pronounced weight loss (up to -6.76% after 6 weeks of dosing). Improved oral bioavailability enables a 15 to 30 mg daily dose of oral ecnoglutide to match or exceed the plasma exposure of weekly subcutaneous GLP-1 analogs for weight loss. In a Phase 3 study in participants with type 2 diabetes (T2DM) ( 742-P, 793-P), weekly subcutaneous ecnoglutide resulted in robust HbA1c declines of up to -2.43% from baseline after 24 weeks of treatment, with up to 35.2% of participants reaching normoglycemia (HbA1c <5.7%) and 43.7% with weight reductions ≥5%. Novel amylin analogs ( 788-P, 789-P) were identified that showed potent in vitro activity. In preclinical models, combination of amylin analogs with ecnoglutide demonstrated a synergistic effect on body weight reduction, with improved efficacy compared to combination of cagrilintide and semaglutide. Moreover, a novel amylin development candidate was identified that is stable at neutral pH, providing the opportunity to co-formulate with ecnoglutide or other GLP-1 analogs to improve ease of use for patients and reduce costs. HANGZHOU, China and SAN FRANCISCO, June 21, 2024 /PRNewswire/ -- Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease, today announced that the company will present positive results from a Phase 3 clinical study of injectable ecnoglutide (XW003) in T2DM patients and from a Phase 1 study for oral ecnoglutide (XW004) in healthy and healthy obese participants, as well as preclinical data for novel amylin analog programs, at the American Diabetes Association (ADA) 84th Annual Conference. Five posters, including one late-breaking poster, will be presented. The ADA conference is being held in Orlando, FL June 21-24, 2024. Late Breaking Poster Presentation (1871-LB): Saturday June 22, 12:30 PM - 1:30 PM "Phase 1 Topline Safety, Efficacy, and Pharmacokinetics of Oral Ecnoglutide" Poster Presentation (742-P): Sunday June 23, 12:30 PM - 1:30 PM "A Phase 3 Evaluation of cAMP Signaling Biased GLP-1 Analog Ecnoglutide (XW003) in Adults with Type 2 Diabetes" Poster Presentation (793-P): Sunday June 23, 12:30 PM - 1:30 PM "Biased GLP-1 analog ecnoglutide (XW003) has improved efficacy relative to unbiased peptides" Poster Presentation (789-P): Sunday June 23, 12:30 PM - 1:30 PM "Discovery of a Novel, Long-Acting Amylin Receptor Agonist for Body Weight Control" Poster Presentation (788-P): Sunday June 23, 12:30 PM - 1:30 PM "Synergistic Body Weight Reduction of GLP-1 Analog Ecnoglutide and Amylin Analogs in Preclinical Animal Models" About ecnoglutide 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 MASH. Ecnoglutide is a novel, biased, long-acting GLP-1 peptide analog optimized for improved biological activity, cost-effective manufacturing, and once weekly subcutaneous dosing. Ecnoglutide has demonstrated treatment benefits for patients with type 2 diabetes and obesity and is safe and well tolerated in Phase 1 through Phase 3 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 XW003 (Phase 3), oral GLP-1 peptide analog XW004 (Phase 1), an oral small molecule GLP-1 receptor agonist XW014 (Phase 1), and novel amylin analogs (preclinical). 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 . SOURCE Hangzhou Sciwind Biosciences Co., Ltd.