Ildong Pharmaceutical Initiates Phase 1 Clinical Trial in Germany for Type 2 Diabetes New Drug Candidate

Goal to Complete Phase 1 Clinical Trial in 2022

Ildong Pharmaceutical Headquarters Exterior (Photo by Ildong Pharmaceutical)

[Asia Economy Reporter Kim Ji-hee] Ildong Pharmaceutical announced on the 30th that its new drug candidate for type 2 diabetes treatment, 'IDG16177,' has entered Phase 1 clinical trials in Germany.

On the 28th (local time), Ildong Pharmaceutical received approval for Phase 1 clinical trials of the new drug candidate IDG16177 from the German Federal Institute for Drugs and Medical Devices (BfArM), the clinical approval authority in Germany. Based on this, the Phase 1 clinical trial will promptly commence locally in Berlin, Germany.

The Phase 1 clinical trial of IDG16177 is planned to focus on confirming safety and tolerability and exploring efficacy in a total of about 100 healthy individuals and patients with type 2 diabetes. After administering IDG16177 to the group composed of healthy individuals, pharmacokinetics, safety, and tolerability will be observed. Based on these results, IDG16177 will be co-administered with metformin monotherapy to a group of type 2 diabetes patients whose blood glucose control is insufficient, to assess its effect on glycated hemoglobin (HbA1c) levels.

Ildong Pharmaceutical's R&D headquarters collaborated with its group affiliate, the clinical pharmacology consulting company AIMS Bioscience, to conduct pharmacokinetic and pharmacodynamic (PK/PD) simulations for designing the Phase 1 clinical trial and determining the dosing regimen.

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Ildong Pharmaceutical aims to complete the Phase 1 clinical trial of IDG16177 within next year.

IDG16177 is a new drug candidate that activates GPR40 (G protein-coupled receptor 40) in pancreatic beta cells to induce insulin secretion and regulate blood glucose. The company explained that preclinical trials confirmed its superiority in activity, efficacy, and safety compared to existing treatments, demonstrating its potential as a new drug. The preclinical research results were recently presented at the American Diabetes Association (ADA) conference, attracting attention.

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