[Asia Economy Reporter Chunhee Lee] Ildong Pharmaceutical has applied for approval of the Phase 1 clinical trial plan for the diabetes treatment candidate substance 'IDG-16177' in Germany.
On the 21st, Ildong Pharmaceutical announced that it had applied to the German Federal Institute for Drugs and Medical Devices (BfArM) for approval of the Phase 1 clinical trial plan for its type 2 diabetes treatment candidate substance IDG-16177.
IDG-16177 is a new drug candidate that activates the G protein-coupled receptor 40 (GPR40) of pancreatic beta cells to induce insulin secretion and regulate blood glucose. Ildong Pharmaceutical explained that it has a distinctive feature in that it can minimize the risk of hypoglycemia caused by drug administration by selectively inducing insulin secretion during hyperglycemia.
In this Phase 1 clinical trial, the safety and efficacy of IDG-16177 will be evaluated in healthy individuals and patients with type 2 diabetes. First, IDG-16177 will be administered once and repeatedly to a group of healthy individuals, and pharmacokinetics, safety, and tolerability will be observed. Based on these results, the therapeutic effect of IDG-16177 will be exploratorily confirmed in the group of patients with type 2 diabetes.
An official from Ildong Pharmaceutical said, “So far, regarding IDG-16177, we have confirmed competitiveness in terms of efficacy such as blood glucose lowering and safety aspects including toxicity issues through non-clinical results such as animal tests.” He added, “Currently, all preparations including securing clinical trial samples have been completed,” and “We plan to promptly start the Phase 1 clinical trial of IDG-16177 locally in Europe as soon as the clinical trial plan is approved.”
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