D&D Pharmatech to Unveil Phase 2 DD01 Clinical Trial Results for the First Time at EASL Congress

Database Lock Completed

D&D Pharmatech, a company specializing in the development of new drugs in the GLP-1 (Glucagon-Like Peptide-1) class, announced on the 22nd that it has completed the database lock for all patients following the 48-week dosing period of the Phase 2 clinical trial of its MASH (Metabolic Dysfunction-Associated Steatohepatitis) treatment candidate 'DD01' currently being conducted in the United States, and has begun procedures to derive the final results.


The 'database lock' is the stage in which all dosing outcomes and safety data collected from patients during the clinical trial are finally verified and confirmed. It is an essential procedure to ensure data integrity of the clinical trial. Once this stage is completed, no further modification or addition to the data is possible, and the efficacy and safety of the drug are ultimately validated through statistical analysis. Typically, top-line data is received from the CRO about 30 days after the 'database lock' is completed.

D&D Pharmatech to Unveil Phase 2 DD01 Clinical Trial Results for the First Time at EASL Congress 원본보기 아이콘

In particular, the results from this clinical trial are set to be presented for the first time to medical professionals and industry experts worldwide through the Late-Breaking Abstract (LBA) session at the 'EASL Congress 2026', the annual meeting of the European Association for the Study of the Liver (EASL), which will be held in Barcelona, Spain starting from the 27th of next month. The company expects to receive the top-line data, including liver biopsy results, after the middle of next month, following the database lock, and plans to release the final, complete analysis in time for the opening of the congress on the 27th of next month.


The lead author of this announcement is Professor Mazen Noureddin, a globally recognized expert in the field of MASH and the principal investigator (PI) of this clinical trial. DD01 has already demonstrated rapid reduction in hepatic steatosis, improvement in related indicators, and potential for liver fibrosis improvement in the previously announced 12-week and 24-week dosing results. Accordingly, there is high market anticipation for the confirmation of liver fibrosis improvement through biopsy in this 48-week long-term dosing outcome.


Seulgi Lee, CEO of D&D Pharmatech, stated, "The completion of this database lock signifies the successful conclusion of the 48-week long-term clinical trial and marks the initiation of the final procedures to prove the differentiated clinical value of DD01." She added, "The fact that DD01 was selected as an LBA at EASL even before obtaining the liver biopsy data demonstrates the high level of interest and expectation from the global academic community regarding its mechanism and potential." She emphasized, "Based on the 48-week biopsy results to be presented at the most prestigious congress, we will do our utmost to achieve strategic partnership outcomes with global big pharma companies."

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.