[Edaily Reporter Kwon Oh Seok ] Samchundang Pharmaceutical ( SAM CHUN DANG PHARM CO. LTD(000250)) announced on the 24th that it has completed dosing for one-third of the total target patient population in the global Phase 1 clinical trial of its oral insulin “SCD0503.”

This clinical trial is being conducted at Profil, a German institution specializing in diabetes clinical trials, and is designed as a head-to-head comparison between SCD0503 and existing subcutaneous insulin in actual Type 1 diabetes patients. Having reached the one-third dosing milestone in about a month since the first dose was administered last June, the company assesses that the trial is proceeding steadily according to schedule.
Given the current pace of progress, SAM CHUN DANG PHARM CO. LTD expects to complete the Phase 1 clinical trial by the fourth quarter of this year and aims to proceed seamlessly with the analysis and announcement of the results thereafter. SCD0503 is an oral insulin that utilizes the company’s proprietary oral drug delivery platform, “S-PASS,” and is designed to reduce the burden on patients associated with insulin injections.
In particular, the company explained that since this clinical trial involves actual Type 1 diabetes patients rather than healthy volunteers and is structured as a direct comparison with subcutaneous insulin—the current standard of care—it is subject to stricter validation criteria than typical Phase 1 trials.
A company official stated, “The trial is proceeding as planned at a world-class clinical research organization specializing in diabetes, and the number of patients who have completed dosing is steadily increasing.” The official added, “We will do our utmost to ensure that the remaining dosing and data analysis are carried out without a hitch, so that we can conclude the trial and announce the results in the fourth quarter of this year.”