SEOUL, South Korea, July 1, 2021
Phase 1 study approved for new drug candidate IDG16177, planned to be completed by 2022
SEOUL, South Korea, July 1, 2021 /PRNewswire/ -- A Phase 1 study on new drug candidate IDG16177 of novel oral treatment for type 2 diabetes, which is being developed by Ildong Pharmaceutical, is initiated in Germany.
On June 28th (local time), Ildong Pharmaceutical obtained approval for the Phase 1 study of new drug candidate IDG16177 from the Federal Institute for Drugs and Medical Devices (BfArM) of German regulatory authority in charge of approving a clinical study. Based on this approval, the company will immediately commence Phase 1 study in Berlin, Germany.
According to Ildong Pharmaceutical, the Phase 1 study of IDG16177 is planned to verify the safety and tolerability of IDG16177 and explore its efficacy in a total of 100 subjects of healthy subjects and type 2 diabetic patients.
IDG16177 is to be administered to treatment group consisting of healthy subjects to observe its pharmacokinetics, safety, and tolerability. Based on the results, combination of IDG16177 with metformin is to be administered to treatment group of type 2 diabetic patients whose blood glucose level is not properly controlled by metformin monotherapy, and the effect of IDG16177 on a glycated hemoglobin (HbA1c) level is to be determined.
PK/PD (pharmacokinetics/pharmacodynamics) simulation for determining the design and administration dose of the Phase 1 study was carried out through cooperation between Ildong Pharmaceutical Department of R&D and a clinical pharmacology consulting company AIMS BioScience, an affiliate of ILDONG group.
Ildong Pharmaceutical aims to complete the Phase 1 study of IDG16177 by 2022.
IDG16177, new drug candidate of GPR40 Agonist class, has mechanism of inducing insulin secretion and controlling blood glucose levels by activating GPR40 (G-protein-coupled receptor 40) in pancreatic beta cells. The candidate's benefit to existing therapies has been verified in nonclinical studies in terms of activity, efficacy, and safety, proving its potential to be a new drug. These evidence came into a spotlight as it was published at a recently held American Diabetes Association (ADA) conference.
Ildong Pharmaceutical is a leading pharmaceutical company in South Korea and envisioned itself to become an innovative R&D-based pharmaceutical company developing novel therapeutic options for diseases with high unmet needs. For additional information, please visit https://www.ildong.com/eng