DD01 U.S. Phase 2 clinical development underway…Initial Phase 2 clinical trial evaluation index results are expected in June
[by Ji, Yong Jun] D&D Pharmatech announced on April 2 its decision to register an Australian patent for its metabolic dysfunction-associated steatohepatitis (MASH) treatment candidate, 'DD01 (development code)', currently under development. The company noted that this marks the first overseas patent registration for DD01 since its initial application in Korea in 2019.
DD01 is a long-acting glucagon-like peptide 1 (GLP-1)/glucagon dual receptor agonist developed by 메이저 바카라 사이트amp;D Pharmatech. Recognized for its potent efficacy in fatty liver reduction, the drug was granted 'Fast Track' designation by the U.S. Food and Drug Administration (FDA) in March 2024 as a treatment for MASH.
The primary endpoint of 메이저 바카라 사이트amp;D Pharmatech’s ongoing Phase 2 clinical trial in the U.S. is to assess the 'proportion of patients achieving a ≥30% reduction in fatty liver disease at 12 weeks compared to baseline,’ as measured by MRI-PDFF. With patient enrollment successfully completed at the end of January, the primary endpoint results are anticipated in June. In the previous Phase 1 clinical trial, the same endpoint was met after just four weeks of administration, with the 40 mg dose group achieving a statistically significant response rate of 75%.
메이저 바카라 사이트amp;D Pharmatech anticipates that if positive Phase 2 clinical trial results are confirmed in June, it will be well-positioned to pursue a significant technology transfer agreement. Furthermore, the company plans to extend the clinical trial for an additional 48 weeks to continuously evaluate key clinical outcomes required for MASH treatment approval by the FDA, including MASH resolution and liver fibrosis improvement, as assessed through tissue biopsy. These extended study results are expected to be available as early as the first half of 2026.
"DD01 is a treatment that has the potential to demonstrate superior efficacy, safety, and patient convenience among the GLP-1 and glucagon receptor (GCG) agonists that have recently been in the spotlight as MASH treatments," said Lee Seulki, CEO of 메이저 바카라 사이트amp;D Pharmatech. "Following the decision to register a patent in Australia, we anticipate further patent approvals in major countries like the United States,” he added. “We remain committed to the stable and effective development in the future, including the ongoing phase 2 clinical trial."