SINGAPORE and SEOUL, South Korea, June 18, 2026 /PRNewswire/ — HistoIndex, a leader in AI-powered digital pathology solutions for fibrosis assessment, and D&D Pharmatech, today announced positive results from HistoIndex’s AI-based quantitative analysis of liver biopsy samples from the Phase 2 clinical trial of zabopegdutide (DD01) – an investigational treatment for metabolic dysfunction-associated steatohepatitis (MASH).
Zabopegdutide is a unique, liver-targeted GLP-1/glucagon receptor agonist with a dominant 11:1 GLP-1-to-glucagon potency ratio, which provides both metabolic and hepatic benefits while maintaining a favorable safety and tolerability profile.
D&D Pharmatech partnered with HistoIndex to include AI-driven histopathological analysis that now corroborates and extends the Phase 2 zabopegdutide trial findings. As announced last month, a blinded pathologist review of the study’s per-protocol population revealed statistically significant improvements in key histologic endpoints including fibrosis improvement and MASH resolution after 48 weeks of treatment. These effects were accompanied by weight loss and improved glycemic control, highlighting its potential as a differentiated therapy for MASH. These results build on earlier findings showing robust liver fat reduction, reduced liver stiffness, and favorable changes in fibrosis markers evident as early as 12 weeks in this trial, underscoring the potential of zabopegdutide as an effective treatment for patients with metabolic liver diseases.
In a fully independent assessment, HistoIndex utilized its proprietary AI-powered quantitative tool, qFibrosis®, to evaluate fibrosis changes in 48-week liver biopsies. This AI analysis focused on 27 protocol-compliant patients whose baseline fibrosis was confirmed as stage F1 or higher via qFibrosis® (16 in the placebo group and 11 in the zabopegdutide dosing group).
Reinforcing the positive results of the standard histopathological analysis, HistoIndex’s data demonstrated meaningful treatment-related improvements in response rates based on steatosis-corrected qFibrosis® stage-level changes, with a significantly greater proportion of patients in the zabopegdutide treatment group achieving ≥1-stage improvement in fibrosis compared with the placebo group (81.8% vs. 18.8%; p = 0.001). Consistent with these stage-level improvements, a fully quantitative assessment showed significant reductions in qFibrosis® values on a continuous scale among treated patients compared with the placebo group. Specifically, the relative change in steatosis-corrected qFibrosis® continuous score from baseline was -41.0% in the zabopegdutide treatment group compared to +9.5% in the placebo group (p < 0.001).
“We are highly encouraged by our 48-week results, which demonstrated zabopegdutide’s ability to both resolve steatohepatitis and reverse liver fibrosis,” said Seulki Lee, Ph.D., President and CEO of D&D Pharmatech. “We also see great value in HistoIndex’s AI-driven quantitative insights that complemented our pathologists’ assessment and strengthened confidence in the observed treatment effects.”
“The HistoIndex fully quantitative analysis adds an important layer of objectivity and sensitivity to the interpretation of histological changes observed in the zabopegdutide Phase 2 trial,” said Dr. Mazen Noureddin, Coordinating Investigator of the zabopegdutide Phase 2 trial, Professor of Medicine and Co-Chair of the Board, Summit Clinical Research Solutions. “The ability of AI-powered tools to sensitively quantify fibrosis changes supports treatment response evaluation and further advances the development of promising therapies for patients with MASH.”
The AI analysis results in this study underscore the growing role of AI-powered fully quantitative pathology in improving precision and reproducibility of fibrosis assessment in MASH clinical trials. Through objective and sensitive measurement of changes in fibrosis in tissue, analysis tools, such as qFibrosis®, are set to enhance treatment evaluation and accelerate the development of next-generation therapies for chronic liver diseases.
Additional details from HistoIndex’s data will be presented at upcoming scientific conferences.
About MASH
Metabolic Dysfunction-associated Steatohepatitis (MASH) is a progressive form of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) characterized by steatosis, ballooning degeneration and inflammation, which can lead to fibrosis (scarring), cirrhosis, liver failure and an increased risk of liver cancer. Pathologist assessment of liver biopsy remains the gold standard for diagnosing and assessing the severity of MASH. Histological categorial scoring systems are often used as surrogate endpoints to evaluate drug efficacy in MASH clinical trials. These endpoints are limited in capturing the complex and heterogeneous nature of the disease. As a result, there is a growing need for more accurate and reliable tools, such as AI-based digital pathology solutions, to improve the assessment of treatment response and disease severity in MASH.
About HistoIndex
Founded in 2010, HistoIndex pioneers in stain-free, fully automated imaging solutions for visualizing and quantifying fibrosis in biological tissues. By combining cutting-edge biophotonic technology with AI-based analysis, HistoIndex provides innovative tools to improve the assessment of fibrosis changes and drug efficacy. HistoIndex’s breakthrough digital pathology solutions are currently used in accelerating clinical research, expediting pharmaceutical drug development, and transforming medical standards.
About D&D Pharmatech
D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with metabolic, fibrotic, and neurodegenerative diseases. The liver pipeline includes zabopegdutide a dual agonist in development for MASH and TLY012, a potent anti-fibrotic in development for cirrhosis and other fibrotic diseases. The neuroscience pipeline includes pegsebrenatide (NLY01), which targets neuroinflammation and glial activation has demonstrated clinical benefit in a Phase 2 Parkinson’s disease study, and NLY02 which targets neuroinflammation and glial activation by a novel mechanism and has been shown to slow neurodegeneration in animal models. Pegsebrenatide, reduced UPDRS scores in Parkinson’s patients younger than 60, and is currently being evaluated in progressive multiple sclerosis.
References:
1.D&D Pharmatech Announcement, May 27, 2026
