D&D Pharmatech (347850.KQ), a drug developer specializing in glucagon-like peptide (GLP)-1 therapeutics, has entered the final stage of securing key data from a Phase 2 trial of DD01, its candidate treatment for metabolic dysfunction-associated steatohepatitis (MASH). Final analysis results will be presented at EASL Congress 2026, the annual meeting of the European Association for the Study of the Liver (EASL), in May.
The company said Monday it has completed a database lock on all patients following the conclusion of 48-week dosing in the Phase 2 trial of DD01 and has begun procedures to derive final results.
A database lock is the stage at which all dosing outcomes and safety data collected from patients during the trial are verified and finalized, a mandatory procedure to ensure the integrity of clinical data. Once this stage is completed, no further modifications or additions to the data are possible, and the drug's efficacy and safety are verified through statistical analysis. Topline data are typically secured within one month after this stage.
The company expects to receive topline data, including biopsy results, after mid-May. Final analysis results are scheduled to be presented through a Late-Breaking Abstract (LBA) session at EASL Congress 2026, the annual meeting of the European Association for the Study of the Liver held in Barcelona, Spain, starting May 27.
Professor Mazen Noureddin, a leading global expert in the MASH field and the principal investigator (PI) of the trial, will participate as the senior author of the presentation. DD01 previously demonstrated rapid reductions in liver fat and improvements in related indicators, as well as potential for improving liver fibrosis, through earlier readouts from its 12-week and 24-week dosing results. Accordingly, the market is holding high expectations for the improvement in liver fibrosis to be confirmed through biopsy in the upcoming 48-week long-term dosing results.
"The completion of this database lock means that the 48-week long-term trial has been successfully concluded, and we have entered the final procedure to prove DD01's differentiated clinical value," D&D Pharmatech CEO Lee Seul-ki said. "Based on the 48-week biopsy results to be presented at the most prestigious academic conference, we will do our best to generate strategic partnering outcomes with global big pharma."
