Boston/Shanghai/November 3rd, 2022 — Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence a Phase I trial of its glucagon-like peptide 1 receptor agonist (GLP-1 RA) ECC5004 for type 2 diabetes mellitus (T2DM). This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004 in healthy participants and subjects with T2DM.
GLP-1 is a peptide secreted from gut enteroendocrine cells to modulate postprandial glycemic excursions through increased glucose dependent insulin secretion, reduced glucagon secretion, and delayed gastric emptying. It also suppresses appetite to reduce body weight through activating GLP-1 receptors in certain areas of the brain. GLP-1 RAs have been approved for treating T2DM and obesity and are recommended as the initial therapy for T2DM patients with or at high risk for atherosclerotic cardiovascular disease or chronic kidney disease. In addition, GLP-1 RAs are currently being studied to treat non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease. However, nearly all the currently approved GLP-1 RAs require administration by subcutaneous injection.
ECC5004 is a novel orally administered small-molecule GLP-1 RA discovered from Eccogene’s internal drug discovery platform and has been demonstrated in preclinical studies to possess desirable efficacy and safety profiles with the potential to be the best-in-class GLP-1 RA. “We are thrilled to share that FDA has cleared IND for our small molecule GLP-1 RA ‒‒ ECC5004. Small molecule GLP-1RA can potentially serve as the cornerstone therapy for many metabolic indications. This approval brings ECC5004, a well-designed small molecule GLP-1RA, closer to providing clinical benefits to hundreds of millions of patients affected by T2DM and obesity globally. We are committed to advancing this program so that we can reach our patients as early as possible.” said Dr. Jingye Zhou, CEO of Eccogene.
Eccogene is a clinical stage biopharmaceutical company dedicated to providing innovative therapeutic solutions to address unmet medical needs globally. The company focuses on discovery and development of translational medicine for metabolic and immune-related diseases.