Seoul, South Korea, July 1, 2021 / PRNewswire / – A phase 1 study of new drug candidate IDG16177, a novel oral treatment for type 2 diabetes being developed by Ildong Pharmaceutical, is being conducted in. initiated Germany.
On June 28thMay (local time) Ildong Pharmaceutical received the approval for the phase 1 study of the new drug candidate IDG16177 from the Federal Institute for Drugs and Medical Devices (BfArM) of the German approval authority, which is responsible for the approval of a clinical study. Based on this approval, the company will begin the phase 1 study immediately Berlin, Germany.
According to Ildong Pharmaceutical, the phase 1 study of IDG16177 is planned to test the safety and tolerability of IDG16177 and to test its effectiveness in a total of 100 subjects from healthy subjects and type 2 diabetics.
IDG16177 is intended to be administered to a treatment group of healthy volunteers to monitor its pharmacokinetics, safety, and tolerability. Based on the results, the combination of IDG16177 with metformin should be administered to a treatment group of type 2 diabetics whose blood sugar levels are not properly controlled by metformin monotherapy, and the effect of IDG16177 on glycated hemoglobin (HbA1c) levels should be determined .
The PK / PD simulation (pharmacokinetics / pharmacodynamics) to determine the design and administration dose of the phase 1 study was carried out in collaboration between the Ildong Pharmaceutical Department of R&D and a clinical pharmacology consultancy AIMS BioScience, a subsidiary of the ILDONG Group, carried out.
Ildong Pharmaceutical aims to complete the Phase 1 study of IDG16177 by 2022.
IDG16177, a new drug candidate in the GPR40 class of agonists, has a mechanism to induce insulin secretion and control blood sugar levels by activating GPR40 (G protein-coupled receptor 40) in pancreatic beta cells. The candidate’s benefit over existing therapies has been demonstrated in non-clinical studies for activity, efficacy, and safety, and its potential as a new drug has been proven. This evidence came into the spotlight when it was released at a recent American Diabetes Association (ADA) conference.
About Ildong
Ildong Pharmaceutical is a leading pharmaceutical company in South Korea and envisioned becoming an innovative, research and development based pharmaceutical company developing novel therapeutic options for diseases with high unmet needs. Please visit https://www.ildong.com/eng for more information
SOURCE Ildong Pharmaceutical Co., Ltd.
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