D&D Pharmatech Announces Topline Results from Phase 2 Trial of MASH Therapy

"Improvement in Liver Fibrosis and Resolution of MASH Confirmed"

Stock Price Hits Upper Limit

D&D Pharmatech, a company specializing in the development of new GLP-1 (glucagon-like peptide-1) drugs, announced on May 27 through a public disclosure that it has released the results of a 48-week liver biopsy from its Phase 2 clinical trial of DD01 (Zabopegdutide), a MASH (metabolic dysfunction-associated steatohepatitis) treatment candidate, currently underway in the United States.

The company stated, "Through this clinical trial, we achieved statistically significant and differentiated results in all histological efficacy endpoints versus placebo, including 'improvement in fibrosis without worsening of MASH,' 'resolution of MASH without worsening of fibrosis,' and the composite endpoint of 'MASH resolution and fibrosis improvement,' which are the core regulatory efficacy endpoints for MASH therapies." D&D Pharmatech's stock price is currently at its upper limit.

The Phase 2 trial of DD01 was conducted at 12 clinical sites in the United States using a randomized, double-blind, placebo-controlled design. A total of 67 patients with MASLD/MASH and a BMI of 25 kg/m² or higher (overweight/obese) were enrolled. Of these, 52 patients were confirmed via biopsy to have MASH and stage F1–F3 liver fibrosis. Among them, 35 patients (19 in the placebo group and 16 in the DD01 group) who completed both baseline and 48-week biopsies and fully complied with the clinical protocol (per protocol group) were included in the histological efficacy analysis.

As a result, statistical significance was confirmed in all three key histological endpoints in the 48-week biopsy assessment.

In the DD01 group, the proportion of patients achieving 'improvement in fibrosis without worsening of MASH' was 34.2% higher than the placebo group (p=0.0323). The proportion of patients achieving 'resolution of MASH without worsening of fibrosis' was 57.2% higher than the placebo group (p=0.0003). Notably, the composite endpoint of 'MASH resolution and fibrosis improvement' was also 32.2% higher in the DD01 group than in the placebo group (p=0.0192), demonstrating DD01’s potential as a differentiated MASH therapy through its dual GLP-1/glucagon mechanism of action.

In addition to these histological improvements, important non-invasive endpoints for MASH therapies, such as liver fat reduction measured by MRI-PDFF and liver stiffness improvement measured by MRE, continued to show sustained improvement through week 48, following the positive results seen at week 12 announced last June. These endpoints, too, showed statistically significant differences versus placebo, further supporting DD01’s ongoing liver improvement effect.

From a safety perspective, DD01 demonstrated excellent tolerability throughout the 48-week dosing period. The most commonly reported adverse events were gastrointestinal symptoms, which were mostly mild or moderate and transient. Remarkably, even though the trial design included only a short, 2-week dose titration period for DD01, the treatment discontinuation rate was similar to other GLP-1 drugs that require dose titration periods of up to 20 weeks or more. The company believes this feature could enhance DD01’s competitiveness in real-world prescribing environments.

Meanwhile, the company has entered into consulting agreements with major U.S.-based investment banks starting in mid-2025 to facilitate global technology transfer and strategic partnerships for DD01, and is currently in discussions with multiple global pharmaceutical companies. Recently, the MASH treatment market has seen aggressive entries by global players, such as GlaxoSmithKline (GSK)’s acquisition of Boston Pharmaceuticals (USD 2 billion), Roche’s acquisition of 89bio (USD 3.5 billion), and Novo Nordisk’s acquisition of Akero Therapeutics (USD 5.2 billion). Having secured competitive histological efficacy results in this trial, the company expects partnership discussions with global pharmaceutical companies, who have been anticipating these results, to accelerate further.

Mazen Noureddin, M.D., Principal Investigator (PI) of the DD01 Phase 2 clinical trial, commented, "For clinicians treating MASH patients, the primary goal is to suppress or reverse liver fibrosis before the disease progresses to irreversible stages such as cirrhosis or liver failure. The fact that more than half of the DD01-treated patients achieved at least a one-stage improvement in fibrosis in less than a year is a highly encouraging outcome for the liver disease field."

He added, "Given its excellent safety profile, DD01 is expected to become a highly competitive next-generation treatment option for patients with metabolic liver diseases."

Seulgi Lee, CEO of D&D Pharmatech, stated, "We are very pleased to have achieved statistical significance across MASH resolution, liver fibrosis improvement, and composite endpoints in the 48-week biopsy results from this Phase 2 trial of DD01. Despite the relatively small patient population, the differentiated histological improvement demonstrated by DD01, now named Zabopegdutide, further solidifies its competitiveness as a next-generation MASH therapy."

She continued, "Given the unprecedented level of global pharmaceutical industry interest in MASH therapies, we will do our utmost to leverage these clinical results to accelerate global partnering discussions and achieve large-scale technology transfer deals."

Meanwhile, these clinical results were unveiled at the EASL Congress 2026, which opened today in Barcelona, Spain. The company plans to sequentially announce additional clinical data—including AI-based pathology analyses, which are gaining increasing importance—at future conferences and events.

This content was produced with the assistance of AI translation services.