Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for
metabolic diseases, has announced promising results from recent clinical studies. At the American Diabetes Association (ADA) 84th Annual Conference, held in Orlando, Florida, from June 21-24, 2024, the company will present findings from their Phase 3 clinical study of injectable
ecnoglutide (XW003) in patients with
type 2 diabetes (T2DM), their Phase 1 study for oral ecnoglutide (XW004) in healthy and healthy obese participants, and preclinical data for novel
amylin analog programs.
In a Phase 1 study of oral ecnoglutide (1871-LB), the compound proved to be safe and well-tolerated, leading to significant weight loss, with reductions of up to 6.76% after six weeks of treatment. Improved oral bioavailability allows for a daily dose of 15 to 30 mg of oral ecnoglutide to achieve or surpass the plasma exposure levels of weekly subcutaneous
GLP-1 analogs, which are used for weight loss.
The Phase 3 study in T2DM participants demonstrated that weekly subcutaneous ecnoglutide (742-P, 793-P) resulted in substantial reductions in HbA1c levels, with declines of up to 2.43% from baseline after 24 weeks of treatment. Additionally, up to 35.2% of participants achieved normoglycemia (HbA1c <5.7%), and 43.7% experienced weight reductions of 5% or more.
Sciwind also identified novel amylin analogs (788-P, 789-P) with potent in vitro activity. In preclinical models, the combination of these amylin analogs with ecnoglutide showed a synergistic effect on body weight reduction, proving to be more effective than the combination of
cagrilintide and
semaglutide. Furthermore, a novel amylin development candidate was found to be stable at neutral pH, facilitating the possibility of co-formulation with ecnoglutide or other GLP-1 analogs. This would enhance patient convenience and potentially reduce treatment costs.
The presentations at the ADA conference included five posters, one of which was a late-breaking poster focusing on the Phase 1 safety, efficacy, and pharmacokinetics of oral ecnoglutide. Other posters covered various aspects of ecnoglutide's performance in T2DM treatment, its efficacy compared to unbiased peptides, and the discovery of a long-acting
amylin receptor agonist for body weight control.
Ecnoglutide, a novel, biased, long-acting GLP-1 peptide analog, has been optimized to enhance biological activity, enable cost-effective manufacturing, and allow for once-weekly subcutaneous dosing. This compound has shown significant treatment benefits for patients with type 2 diabetes and
obesity and has been safe and well-tolerated across Phase 1 to Phase 3 clinical studies.
Sciwind Biosciences, based in Hangzhou and San Francisco, focuses on the discovery and development of breakthrough therapies to combat metabolic diseases. Its product pipeline features potentially first-in-class and best-in-class drug candidates, including the long-acting
GLP-1 peptide analog XW003, the oral GLP-1 peptide analog XW004, an oral small molecule
GLP-1 receptor agonist
XW014, and novel amylin analogs in preclinical stages. Sciwind has developed proprietary technologies for oral peptide and inhaled protein therapeutic delivery, leading to the identification of several promising drug candidates.
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