Selected as AASLD LBA/Oral Presentation for 2 consecutive years... Introduction of MASH resolution and liver fibrosis improvement results
48-week tissue biopsy and additional clinical analysis revealed... Global partnering discussions underway
D&D Pharmatech's (347850) metabolic steatohepatitis (MASH) treatment candidate 'zabopegdutide (DD01)' will present 48-week clinical data at the American Society for the Study of the Liver Diseases (AASLD) annual conference. As it has been selected for Late-Breaking Abstract (LBA) and oral presentations for two consecutive years, discussions on global technology transfer are underway, so interest is also focused on presentations at this conference.
D&D Pharmatech announced on the 6th that the results of the 48-week US phase 2 clinical trial of DD01 were selected as the LBA for ‘The Liver Meeting 2026’ to be held in Denver, Colorado, USA from November 5th to 9th. The oral presentation will be held on the afternoon of the 8th local time.
DD01 is a long-acting dual agonist that acts simultaneously on GLP-1 and glucagon receptors. D&D Pharmatech conducted a randomized, double-blind, placebo-controlled phase 2 clinical trial targeting 67 MASLD/MASH patients with overweight or obesity at 12 clinical trial Institutional Investors in the United States.
The main results of the 48-week tissue biopsy to be covered in this AASLD were first revealed at the European Association for the Liver Association (EASL 2026) last May. In an analysis of 35 patients who followed the protocol (16 in the DD01 treatment group and 19 in the placebo group), the proportion of patients who achieved ‘improvement in liver fibrosis by stage 1 or higher without worsening of MASH’ was found to be 50.0% in the DD01 treatment group and 15.8% in the placebo group. ‘Resolution of MASH without exacerbation of liver fibrosis’ was 62.5% and 5.3%, respectively.
The proportion of patients who met both conditions simultaneously was 37.5% in the DD01 treatment group and 5.3% in the placebo group. All three indicators achieved statistical significance.
The company completed the 48-week phase 2 clinical trial and received the final results report (CSR) last August. Through this, the safety and efficacy of DD01 were confirmed, and consistent improvement effects were confirmed not only in histological evaluation but also in fatty liver, liver stiffness, body weight, blood sugar, and lipid metabolism indicators.
With this selection, DD01 has been listed in the AASLD LBA and oral presentation for two consecutive years. Last year, the 12th week liver fat reduction result, which was the primary evaluation index of the same clinical trial, was selected as LBA. This year, the 48-week tissue biopsy results and additional clinical analysis are at the center of the presentation.
The presentation will be given by Professor Mazen Noureddin, the lead researcher of the DD01 phase 2 clinical trial. Professor Noureddin also presented the results of his DD01 research at this year's EASL.
This announcement is also noteworthy in that it comes at a time when discussions on the global technology transfer of DD01 are underway. D&D Pharmatech is discussing technology transfer with global partners based on the completion of phase 2 clinical trials and securing CSR.
The announcement of AASLD itself does not mean that technology transfer has been completed. However, as the 48-week tissue biopsy results and additional clinical analysis are presented to global liver disease experts, it is expected to be an opportunity to publicize the clinical and commercial value of DD01.
Seol-gi Lee, CEO of D&D Pharmatech, said that being selected for the AASLD LBA and oral presentation for two consecutive years since last year is an achievement that shows that the DD01 clinical results are receiving high academic attention from global liver disease experts. In this announcement, the results of the 48-week tissue biopsy and additional clinical analysis were revealed to publicize the differentiated clinical competitiveness of DD01, and the company expressed its intention to do its best to ensure that ongoing technology transfer discussions with global partners lead to results.
