Selected for AASLD LBA and Oral Presentation for Two Consecutive Years… Spotlight on MASH Resolution and Liver Fibrosis Improvement Results
48-Week Biopsy and Supplemental Clinical Data to be Unveiled; Global Partnering Discussions Underway
D&D Pharmatech (347850) is set to present 48-week clinical data for its metabolic dysfunction-associated steatohepatitis (MASH) therapeutic candidate, ‘Zavopegdutide (DD01),’ at the American Association for the Study of Liver Diseases (AASLD) annual meeting. As the drug has been selected for a Late-Breaking Abstract (LBA) and oral presentation for the second consecutive year, expectations are rising amid ongoing global licensing discussions.
On the 6th, D&D Pharmatech announced that the 48-week results of its U.S. Phase 2 clinical trial for DD01 have been selected as an LBA for ‘The Liver Meeting 2026,’ which will take place in Denver, Colorado, from November 5 to 9. The oral presentation is scheduled for the afternoon of the 8th (local time).
DD01 is a long-acting dual agonist that targets both GLP-1 and glucagon receptors. D&D Pharmatech conducted a randomized, double-blind, placebo-controlled Phase 2 study across 12 clinical sites in the U.S., involving 67 patients with MASLD/MASH accompanied by overweight or obesity.
The primary results of the 48-week biopsy to be discussed at AASLD were initially disclosed at the European Association for the Study of the Liver (EASL 2026) in May. In an analysis of 35 patients who adhered to the protocol (16 in the DD01 group and 19 in the placebo group), the proportion of patients achieving "at least a 1-stage improvement in liver fibrosis without worsening of MASH" was 50.0% for the DD01 group compared to 15.8% for the placebo group. "MASH resolution without worsening of liver fibrosis" was achieved by 62.5% and 5.3%, respectively.
The percentage of patients meeting both criteria simultaneously was 37.5% for the DD01 group and 5.3% for the placebo group. All three metrics achieved statistical significance.
The company completed the 48-week Phase 2 trial and received the final Clinical Study Report (CSR) in August. This confirmed the safety and efficacy of DD01, with the company noting consistent improvements not only in histological evaluations but also in liver fat content, liver stiffness, body weight, and markers of glucose and lipid metabolism.
This selection marks the second consecutive year that DD01 has been featured as an AASLD LBA and oral presentation. Last year, the 12-week liver fat reduction results—a primary endpoint of the same clinical trial—were selected for an LBA. This year, the focus shifts to the 48-week biopsy results and additional clinical analyses.
The presentation will be delivered by Professor Mazen Noureddin, the principal investigator of the DD01 Phase 2 trial, who also presented the results at EASL earlier this year.
The upcoming presentation is particularly significant as it coincides with ongoing global licensing discussions. Leveraging the completion of the Phase 2 trial and the finalized CSR, D&D Pharmatech is currently engaged in talks with potential global partners.
While an AASLD presentation does not equate to the conclusion of a licensing deal, showcasing the 48-week biopsy results and supplemental data to global liver disease experts is expected to serve as a pivotal opportunity to demonstrate the clinical and commercial value of DD01.
Seulki Lee, CEO of D&D Pharmatech, stated that being selected for an AASLD LBA and oral presentation for two consecutive years underscores the high level of academic interest in DD01’s clinical outcomes among global liver disease experts. He added that the company would do its utmost to highlight the differentiated clinical competitiveness of DD01 during the presentation and work toward turning current licensing discussions into tangible successes.
