Sam Chun Dang Pharm announced on Friday that it has received final approval from the European Medicines Agency (EMA) for the Phase 1 clinical trial (CTA) of its oral insulin candidate SCD0503.
The trial will be conducted at Profil, a specialized diabetes clinical research institution in Germany that has been at the forefront of initial validation for major anti-diabetic substances worldwide.
Profil is a world-renowned clinical institution that has conducted numerous diabetes trials for global pharmaceutical giants, including Novo Nordisk A/S’s Ozempic and Wegovy, as well as for Sanofi S.A. and Eli Lilly and Company.
Through this trial, Sam Chun Dang Pharm. aims to compare the absorption characteristics, blood glucose control capability, and safety profile of SCD0503 against existing subcutaneous insulin in patients with type 1 diabetes.
To maximize the reliability of results, the company will employ the Euglycemic Clamp method, an international standard testing procedure also used in approval trials for original insulin formulations.
The Euglycemic Clamp is a testing technique that measures a drug’s blood glucose-lowering effect while maintaining a steady blood sugar level, serving as the global benchmark for evaluating insulin efficacy.
Sam Chun Dang Pharm. will conduct both pharmacokinetic (PK) assessments of blood drug concentrations and pharmacodynamic (PD) evaluations based on glucose infusion rate (GIR) to comprehensively and scientifically verify the efficacy of the oral insulin.
To enhance objectivity, the clinical trial design features a randomized, double-blind, double-dummy method with four treatment groups and a six-period crossover design.
A spokesperson for Sam Chun Dang Pharm. stated that this European Phase 1 trial will demonstrate the superior absorption characteristics and blood glucose control efficacy of the oral insulin. It also aim to successfully progress to Phase 2a, which will ultimately change the paradigm of the global diabetes market.