D&D Pharmatech announced on the 16th that its metabolic dysfunction-associated steatotic liver disease (MASH) treatment, 'DD01,' has demonstrated efficacy in U.S. phase 2 clinical trials.
DD01 is a dual-action agent developed by D&D Pharmatech that combines glucagon (GCG) and glucagon-like peptide-1 (GLP-1). It simultaneously targets GLP-1, which suppresses appetite and promotes insulin secretion, and GCG, which rapidly breaks down fat, providing benefits such as reducing liver fat as well as controlling blood sugar and weight. This combination led to its designation as a fast track drug, eligible for expedited review and approval by the U.S. Food and Drug Administration (FDA) in March of last year.
MASH was previously known as non-alcoholic steatohepatitis (NASH) for some time, but to emphasize metabolic factors, it was officially renamed MASH by the Global Liver Conference last year. Metabolism refers to the process by which the human body breaks down nutrients to obtain energy and expel waste products. MASH is a condition in which fat accumulates due to problems in the metabolic process, accompanied by inflammation and liver damage, potentially leading to liver cirrhosis and liver cancer.
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 steatotic liver disease (MASH) who were overweight or obese. It was conducted in 12 institutions in the U.S., involving 68 patients who were divided into a DD01 treatment group and a placebo group.
In the primary evaluation of phase 2, the difference in the percentage of patients between the DD01 treatment group and the placebo group whose intrahepatic fat content decreased by at least 30% was compared. As a result, the percentage of patients with liver fat reduced by over 30% post-treatment was 11.8% in the placebo group, while in the DD01 treatment group, it was 75.8%.
Following this primary evaluation, the company plans to continue clinical trials to derive secondary evaluation results and expects to receive the final clinical study report (CSR) in the third quarter of 2026.
Isulgi, the CEO of D&D Pharmatech, noted, “As interest from multinational pharmaceutical companies in MASH treatments is growing, we will actively pursue partnerships based on the competitive clinical results confirmed this time to ensure successful large-scale technology transfers.”