Eccogene, a clinical-stage biopharmaceutical company, has announced the dosing of the first patient in a Phase 1b clinical trial of AZD5004/ECC5004 in China, marking a significant milestone in the development of this investigational oral small molecule GLP-1 receptor agonist. The trial represents a crucial step to support local regulatory requirements, following an earlier Phase 1 trial conducted exclusively in the United States.
Novel Oral GLP-1 Receptor Agonist Development
AZD5004/ECC5004 is an investigational oral small molecule GLP-1 receptor agonist currently being investigated for the treatment of type 2 diabetes and obesity or overweight with at least one comorbidity. The molecule was discovered by Eccogene and licensed globally to AstraZeneca, with Eccogene retaining co-development and co-commercialization rights in China.
"We recognize the significant unmet need in China that exists in type 2 diabetes and obesity/overweight, and the need to deliver new therapies to these patients," said Jingye Zhou, Chief Executive Officer of Eccogene. "Together with our partner AstraZeneca, we are advancing the development of AZD5004/ECC5004 in China with the aim of creating a convenient once-daily oral GLP-1RA with no food-related restrictions."
Strategic Partnership and Clinical Program
The collaboration between Eccogene and AstraZeneca represents a strategic approach to addressing cardiometabolic diseases. Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, emphasized the drug's potential within AstraZeneca's cardiovascular, renal, and metabolism (CVRM) portfolio.
"The start of this Phase 1b trial in China marks an important milestone in the extensive clinical program for AZD5004/ECC5004, an oral small molecule GLP-1RA which has significant potential as part of our extensive CVRM portfolio," Barr commented. "Overweight and obesity are key drivers of cardiometabolic disease, and we are developing AZD5004/ECC5004 to be a part of the solution for this complex and urgent public health issue, both as a monotherapy and in combination with other agents."
Global Phase 2b Trial Program
AstraZeneca is currently conducting two global Phase 2b multicenter trials to evaluate the efficacy and safety of AZD5004/ECC5004. The VISTA trial (NCT06579092) focuses on participants living with obesity or overweight with at least one weight-related comorbidity, while the SOLSTICE trial (NCT06579105) targets participants with type 2 diabetes. Both trials evaluate the drug administered orally once daily.
Company Focus and Pipeline
Eccogene specializes in developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions. The company has dedicated its efforts to discovering safer and more effective oral therapies that can be used alone or synergistically with GLP-1 receptor agonists to treat conditions beyond obesity.
Zhou noted that this milestone "reinforces Eccogene's position as an innovator in advancing novel, differentiated oral therapies for cardiometabolic diseases with broad commercial potential." The company's diverse pipeline of small molecule candidates leverages expertise in translational research, small molecule drug discovery, and cardiometabolic disease understanding.
