Sciwind Biosciences APAC CO Pty. Ltd.

HANGZHOU, China and SAN FRANCISCO, Oct. 9, 2022 /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 dosing in a Phase 1 clinical trial evaluating XW014, a novel oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. XW014 is being developed for the treatment of obesity and type 2 diabetes. The Phase 1 trial is a double-blind, randomized, placebo controlled, single and multiple ascending dose study that is being conducted in the US. The study plans to enroll up to 104 healthy volunteers and patients with type 2 diabetes. Participants in the multiple ascending dose cohorts of the trial, which will include healthy individuals with elevated body mass index and patients with type 2 diabetes, will be treated with study drug for 6 weeks. The objective of the study is to evaluate the safety and tolerability, food effect, pharmacokinetics, pharmacodynamics, as well as early treatment effects of XW014. "As an orally bioavailable small molecule GLP-1 receptor agonist, XW014 has the potential to become a new and differentiated treatment option for patients with obesity and type 2 diabetes without the burden of daily or weekly injections," said Martijn Fenaux, PhD, SVP of Nonclinical Development & Translational Science at Sciwind. "XW014 is also amenable to the development of fixed-dose oral combination therapies with other classes of drugs of complementary mechanisms to further improve treatment outcomes. Initiation of this Phase 1 study is an important first step for the development of this promising molecule. We expect to report initial topline data from this trial in the second half of 2023." About XW014 XW014 is an orally bioavailable small molecule GLP-1 receptor agonist in development for the treatment of obesity and type 2 diabetes. As a small molecule, XW014 is easier to manufacture than GLP-1 peptide drugs and readily bioavailable after oral dosing. It has the potential to be co-formulated with other oral drugs of complementary mechanisms to generate more effective combination treatments for metabolic diseases. GLP-1 is an incretin peptide hormone that is naturally released after a meal and acts on the digestive tract, liver, pancreas, and central nervous system to maintain physiological health. GLP-1 receptor agonists have shown clinical benefits in treating obesity, type 2 diabetes, and liver disease. 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-lasting GLP-1 peptide analog XW003 (Phase 2), 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. SOURCE Hangzhou Sciwind Biosciences Co., Ltd.

Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat metabolic disease, today announced the initiation of subject dosing in its Phase 1 clinical trial of XW004. XW004 is an oral tablet formulation of Ecnoglutide, a novel long-lasting GLP-1 peptide analogue under development for the treatment of obesity, type 2 diabetes and NASH. Co-formulation of the peptide agonist with an oral absorption enhancer prevents deactivation in the digestive tract and allows for daily oral administration. Preclinical studies have demonstrated good safety and efficacy profiles for XW004. The single-center, double-blind, placebo-controlled, and multiple ascending dose (MAD) study will evaluate XW004 at doses of up to 30 mg daily in approximately 56 healthy volunteers. Participants in the trial, which is being conducted in Australia, will be treated with the study drug once daily for 15 days with a 21-day treatment-free follow-up period. The objective of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW004. "As a once-daily oral GLP-1 tablet, XW004 has the potential to offer a more convenient treatment option for patients with metabolic disease and improve the overall compliance in broader patient populations. It is also amenable to developing oral combination treatments with other drugs to further enhance treatment outcomes," said Dr. Hai Pan, founder and CEO of Sciwind. "Initiation of this Phase 1 MAD study is an important first step towards developing XW004 as a safe and effective treatment for patients living with metabolic disease."