[Market Focus] D&D Pharmatech Surges on Announcement of Phase 2 Clinical Data for MASH Treatment

As of 9:30 a.m. on June 16, D&D Pharmatech shares were trading at 122,700 won on the KOSDAQ market, up 25.59% from the previous session's closing price. On this day, D&D Pharmatech announced topline data from its U.S. Phase 2 clinical trial for 'DD01,' a treatment for metabolic dysfunction-associated steatohepatitis (MASH).

Metabolism refers to the process by which the human body breaks down nutrients to obtain energy and expel waste products. MASH is a disease in which problems in the metabolic process, unrelated to alcohol consumption, cause fat to accumulate in the liver, leading to inflammation and liver damage. This condition can progress to cirrhosis, where the liver becomes hardened, and even to liver cancer.

DD01, developed in-house by D&D Pharmatech, simultaneously targets glucagon (GCG), which rapidly breaks down fat, and glucagon-like peptide-1 (GLP-1), which suppresses appetite and promotes insulin secretion. This dual targeting not only reduces fatty liver but also helps control blood sugar and body weight. In March of last year, the U.S. Food and Drug Administration (FDA) designated DD01 as a Fast Track drug, making it eligible for expedited review and approval.

This Phase 2 clinical trial evaluated the efficacy, safety, and tolerability of DD01 over 48 weeks in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), both accompanied by overweight or obesity. The trial was conducted at 12 sites in the United States, with 68 patients divided into a DD01 treatment group and a placebo group.

For the primary endpoint of Phase 2, the trial compared the proportion of patients in each group who experienced at least a 30% reduction in intrahepatic fat content. The results showed that 75.8% of patients in the DD01 group achieved at least a 30% reduction in fatty liver, compared to 11.8% in the placebo group.

Following this primary evaluation, the company plans to continue the trial to obtain results for the secondary endpoints and expects to receive the final clinical study report (CSR) in the third quarter of 2026.