New drug development corporations D&D Pharmatech said on the 2nd that it completed week-48 dosing for all enrolled patients participating in the phase 2 clinical trial in the United States of "DD01," a treatment candidate for MASH (metabolic dysfunction–associated steatohepatitis).
Accordingly, the week-48 topline (key endpoint) results, including liver biopsy findings that are central to meeting U.S. Food and Drug Administration (FDA) approval requirements, are expected to be released as early as May.
DD01 is a dual agonist independently developed by D&D Pharmatech that simultaneously targets the glucagon-like peptide-1 (GLP-1) and glucagon (GCG) receptors, and it is being developed as a long-acting, once-weekly injectable.
GLP-1 is a hormone that promotes insulin secretion from the pancreas, contributing to blood sugar control and weight loss. Glucagon is a hormone that activates energy metabolism in the liver and promotes fatty acid breakdown in adipose tissue, and in recent years its effects on reducing liver fat and improving metabolism have drawn attention.
The company is conducting a phase 2 trial in the United States for patients with metabolic dysfunction–associated steatotic liver disease (MASLD) and MASH. The company said, "With week-48 dosing completed, we are formally beginning the liver biopsy analysis procedures to evaluate MASH resolution and fibrosis improvement, which are key FDA approval endpoints," adding, "We have already adopted an artificial intelligence (AI)–based tissue analysis tool and are preparing."
Earlier, D&D Pharmatech demonstrated positive efficacy in the primary 12-week assessment in June last year. In the DD01 treatment arm, the proportion of patients with at least a 30% reduction in liver fat reached 75.8% at week 12, with an average liver fat reduction of 62.3%.
Lee Seul-gi, CEO of D&D Pharmatech, said, "With the 48-week dosing completed smoothly for all patients, we will secure competitive clinical results and accelerate global partnerships."