DND Pharmatech Begins Patient Dosing in US Phase 2 Clinical Trial of MASH Treatment

DND Pharmatech announced on the 21st that it has completed the first patient dosing in the Phase 2 clinical trial in the United States for DD01, a metabolically targeted treatment for metabolic dysfunction-associated steatohepatitis (MASH) developed in-house.

DND Pharmatech CI [Photo by DND Pharmatech]

DD01 is a long-acting glucagon-like peptide-1 (GLP-1) and glucagon dual receptor agonist. In a Phase 1 clinical trial conducted in the U.S. on obese and overweight patients with diabetes and MASH, statistically significant results were confirmed, showing more than a 50% reduction in fatty liver after only four weeks of short-term dosing. Thanks to this fatty liver reduction effect, DD01 was designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA) in March, allowing expedited clinical development.

The current Phase 2 clinical trial will be conducted simultaneously at 12 clinical trial sites across the U.S., targeting 68 overweight and obese patients with a body mass index (BMI) of 25 kg/m² or higher who have MASH or related conditions. To evaluate the efficacy and safety of DD01, the study will be randomized, double-blind, placebo-controlled, and parallel-group over 48 weeks.

The primary efficacy endpoint of the study is set to measure the reduction rate of fatty liver in the DD01 treatment group compared to the placebo group at 12 weeks, using magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) methodology. The company expects to confirm clinical results as early as July next year. After the 12-week mark, the trial will continue up to 48 weeks to verify various efficacy and safety indicators related to FDA approval of MASH treatments, including MASH resolution, fibrosis improvement, fatty liver reduction, glycated hemoglobin reduction, and weight loss, including tissue biopsy.

Seulgi Lee, CEO of DND Pharmatech, stated, “From the initiation of the U.S. clinical sites to the first patient dosing, everything is progressing smoothly as planned.” She emphasized, “Recent MASH clinical research results have reported that among various GLP-1-based drugs, dual agonists targeting both GLP-1 action and glucagon receptors that directly act on the liver may be the most effective MASH treatments.” She added, “DD01 is a differentiated GLP-1 and glucagon dual agonist that demonstrated efficacy in Phase 1 by reducing fatty liver levels, an important marker of liver fibrosis improvement, by more than 50% with just four weeks of dosing. If additional fatty liver reduction from long-term dosing is confirmed by the mid-next year results of the 12-week Phase 2 trial, global technology licensing could also be possible in the near future.”