Sciwind Biosciences Announces Initiation of Dosing in Phase 1 Clinical Trial Evaluating XW014, an oral small molecule GLP-1 receptor agonist for the Treatment of Obesity and Type 2 Diabetes

HANGZHOU,China and SAN FRANCISCO,Oct. 10,2022 -- 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). Sciwindhas 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.