D&D Pharmatech, a company specializing in developing new drugs in the glucagon-like peptide (GLP)-1 class, said on the 16th that DD01, its investigational new drug candidate for treating metabolic dysfunction-associated steatohepatitis (MASH) now in a phase 2 trial in the United States, was selected as a "2025 National New Drug Development Project outstanding task" by the Korea Drug Development Fund (KDDF).
KDDF held the "2025 National New Drug Development Project outstanding task presentation and 2026 new task call plan briefing" on the 16th at the Fairmont Ambassador Seoul Grand Ballroom. D&D Pharmatech's DD01 task (phase 2 stage) was selected as an outstanding task in recognition of its excellent development progress and potential, and an awards ceremony was held that day.
DD01, selected this time as an outstanding task, is a dual agonist of the GLP-1 and glucagon receptors developed in-house by D&D Pharmatech. On Jun. it was selected as a KDDF "new drug clinical development phase 2 stage" task and is receiving about 4.55 billion won in research and development funding over 24 months, and it is currently conducting a phase 2 trial in the United States dosing MASH patients for 48 weeks.
MASH is a disease in which fat accumulates in the liver due to problems in metabolic processes, irrespective of alcohol consumption, causing inflammation and damage. It can progress to cirrhosis, in which the liver hardens, or to liver cancer, and currently only two MASH treatments have been approved. The process by which MASH develops is complex, which is a major reason why designing therapies is not easy.
DD01 has demonstrated outstanding efficacy and safety through prior clinical data analyses. The company said that in the 12-week phase 2 interim analysis released in Jun., it confirmed a statistically significant reduction in fatty liver compared with placebo. Notably, it achieved in just 12 weeks a level of fatty liver reduction similar to that seen after 48 weeks of dosing with the competing drug survodutide from C. H. Boehringer Sohn AG & Co. KG (survodutide), demonstrating high potential as a MASH treatment.
D&D Pharmatech plans to complete 48-week dosing for all patients within the year and announce topline results around May next year, including biopsy-based fibrosis improvement, a key endpoint for MASH treatment approval.
Im Sung-mook, head of research and development at D&D Pharmatech, said, "Following the selection of the National New Drug Development Project task in Jun., being named an outstanding task further validates the smooth progress of DD01's global clinical program and the competitiveness of the clinical results," and added, "With active support from the project group and the government, we are focusing the company's capabilities on successfully completing the remaining clinical work and producing meaningful business outcomes related to DD01."