[Edaily Reporter Kwon Oh-seok] #Samchundang Pharmaceutical announced on the 17th that it has begun administering the first dose to patients in the global Phase 1 clinical trial of its oral insulin candidate “SCD0503.” After receiving approval for its Clinical Trial Application (CTA) from the European Medicines Agency (EMA) on the 28th of last month, the company has moved on to the actual patient dosing phase, marking the start of a full-scale validation process toward the commercialization of “oral insulin.”

The clinical trial is being conducted by Profil, a German CRO specializing in diabetes and metabolic diseases, and will directly compare the oral formulation of SCD0503 with existing subcutaneous insulin in patients with type 1 diabetes. The trial design is randomized, double-blind, and double-dummy, and adopts a 4-arm, 6-period crossover design to precisely examine differences between the drugs.
The primary endpoints are relative bioavailability and pharmacokinetic (PK) and pharmacodynamic (PD) characteristics under euglycemic clamp conditions. The euglycemic clamp is an internationally recognized standard method for analyzing the time-action characteristics of insulin formulations and is an evaluation technique approved by both the U.S. FDA and the EMA. A key advantage is its ability to quantify the actual blood glucose-lowering effect using the glucose infusion rate (GIR) as an indicator.
The decision to use patients with type 1 diabetes as the study population was also made to enhance the precision of this evaluation. Since these patients have virtually no endogenous insulin secretion, the PK and PD profiles of exogenously administered insulin can be observed under relatively unconfounded conditions, making this an approach widely used in early-stage insulin development.
SCD0503 is a pipeline product currently under development based on Samchundang Pharmaceutical’s oral absorption platform, “S-PASS.” Because insulin is easily broken down in the gastrointestinal tract and has difficulty crossing the intestinal barrier, the development of oral formulations has long been considered a major challenge, and to date, no oral insulin product has been successfully commercialized.
The company explained, “This first dosing marks the starting point for elucidating the clinical characteristics of SCD0503,” adding, “We will systematically accumulate pharmacokinetic, pharmacodynamic, and safety data through clinical designs and evaluation methods that comply with international standards.” Samchundang Pharmaceutical plans to finalize its follow-up development strategy and roadmap for advancing to subsequent clinical phases based on the results obtained from the Phase 1 trial.