Samcheondang Pharmaceutical has corrected two disclosures related to its ongoing oral insulin (SCD0503) clinical trial in Europe. This measure was taken to add an explanation regarding the criteria for calculating the target number of trial subjects, and does not involve any changes to the clinical trial's design, schedule, or approval.

According to the company on the 5th, the corrections apply to the 'Major Management Matters Related to Investment Decisions (Clinical Trial Plan Approval Application)' disclosed on March 19, 2026, and the 'Major Management Matters Related to Investment Decisions (Decision on Clinical Trial Plan Approval)' disclosed on May 29, 2026.

The company revised the previous disclosure, which stated 'Total Dosing Subjects: 64,' to '16 enrolled subjects (16 subjects × 4 dose groups = 64 administrations)' and added the specific calculation basis. According to the disclosure, the trial will be conducted using a randomized, double-blind, double-dummy design with four treatment groups in a six-period crossover format. Since each subject alternately receives treatments across three experimental groups and one control group, the previously stated figure of 64 was based on the total number of dosing occasions rather than the actual number of enrolled subjects.

This clinical trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of the oral insulin SCD0503 compared to subcutaneous insulin in patients with type 1 diabetes under euglycemic clamp conditions.

Meanwhile, according to the approval disclosure, the European EMA initially granted approval only for Phase 1 out of the originally applied Phase 1/2 trial. The company plans to obtain additional approval for Phase 2 in consultation with its CRO. The company emphasized once again, "This correction does not change the trial design or approval details, but is intended to supplement the explanation regarding the notation of target trial subjects."