[Photo and Text by Hong Ju-yeon, Edaily] DND Pharmatech has confirmed statistically significant improvements in fibrosis using artificial intelligence (AI) in a Phase 2 clinical trial for its metabolic and alcoholic steatohepatitis (MASH) treatment. DND Pharmatech is also accelerating discussions on global technology transfer to rapidly commercialize the MASH treatment.

MASH Treatment Demonstrates Statistical Significance

Lee Seul-ki, CEO of DND Pharmatech, personally attended a corporate briefing held at the Kiwoom Securities headquarters in Yeongdeungpo-gu, Seoul, on the 11th, where she unveiled detailed 48-week data from the Phase 2 clinical trial of Zabo Pegduotide (development code name DD01), a candidate treatment for metabolic and alcoholic steatohepatitis (MASH). CEO Lee presented a comprehensive data package covering key biopsy indicators, AI-based fibrosis assessment, non-invasive markers, and metabolic improvements, expressing her commitment to actively pursue global technology transfer discussions.

The highlight of the briefing was the release of additional analysis data supporting the previously disclosed biopsy results. In the previously announced U.S. Phase 2 clinical trial, the proportion of patients who achieved MASH resolution without worsening liver fibrosis was 62.5% in the DD01 group and 5.3% in the placebo group. The proportion of patients who showed improvement in liver fibrosis without MASH progression was 50% in the DD01 group and 15.8% in the placebo group. The proportion of patients who achieved both MASH resolution and improvement in liver fibrosis was 37.5% and 5.3%, respectively. All three indicators demonstrated statistical significance.

DND Pharmatech has released AI-based tissue biopsy interpretation data for the first time. In addition to traditional interpretations by multiple pathologists, DND Pharmatech introduced the AI fibrosis analysis program qFibrosis to obtain interpretation results based on three criteria: (1) pathologist-only interpretation, (2) independent AI interpretation, and (3) pathologist interpretation referencing AI results.

qFibrosis is an AI system that quantifies the degree of fibrosis by measuring the amount and structure of collagen. According to DND Pharmatech, this system enables more detailed and sensitive measurements than pathologist readings, which rely on categorical judgments. It has been applied not only to clinical trials by Madrigal, 89bio, and Akeron Therapeutics but also to Eli Lilly’s Phase 3 clinical trial for turzepatide.

While the current FDA approval criteria primarily rely on pathologist interpretations, AI interpretation results play a significant role in due diligence processes for licensing-out and mergers and acquisitions by global pharmaceutical companies. D&D Pharmatech is also discussing joint conference presentations with HistoIndex, the developer of qFibrosis.

CEO Lee explained that statistically significant improvements in fibrosis were confirmed across all three criteria analyzed using qFibrosis. Improvement in fibrosis without MASH progression was observed in 50% of cases based on pathologist analysis, 72.7% based on AI analysis, and 44.4% in pathologist readings that referenced AI results. Additionally, among the results showing fibrosis improvement using qFibrosis, resolution of MASH without fibrosis was observed in 54.5% of cases, and the combined achievement of MASH resolution and fibrosis improvement was also 54.5%.

Data on non-invasive markers and metabolic improvements were also released. Based on magnetic resonance imaging proton density fat fraction (MRI-PDFF), the average reduction in fatty liver at 48 weeks reached 68%. Body weight in the DD01 treatment group decreased by 7.4% at 48 weeks. The proportion of patients achieving at least a 5% weight loss was 61.9%. Visceral fat decreased by 18.7%. Given that MASH is a condition closely associated with obesity, insulin resistance, and metabolic disorders, the fact that improvements in liver tissue and metabolic profiles occurred simultaneously is cited as a key differentiating factor.

In terms of dosing convenience, the short dose escalation period was emphasized. DD01 reaches the maintenance dose of 40 mg after just a two-week Phase 1 dose escalation. Even Altimun’s pembidutide, which is considered to have the shortest dose escalation period among competing GLP-1 candidates, takes eight weeks. The clinical discontinuation rate due to gastrointestinal side effects was 8%.

GSK Acquires MASH Treatment Epimospermin for Approximately 3 Trillion Won

The presentation also provided a comparative example to gauge the scale of the technology transfer. The contract under which GlaxoSmithKline (GSK) acquired the MASH treatment epimospermin from Boston Pharmaceuticals was cited as a benchmark. It was a major deal with a total contract value of $2 billion (approximately 3 trillion won), including an upfront payment of $1.2 billion (approximately 1.8 trillion won). However, D&D Pharmatech explained that since it was an asset acquisition without royalties, the proportion of the upfront payment was higher than in typical technology transfers, a factor that should be taken into account.

D&D Pharmatech also highlighted the superior efficacy of DD01 compared to epimospermin. While epimospermin offers greater convenience with once-every-four-weeks dosing, DD01 achieved statistical significance across all composite endpoints—including MASH resolution and fibrosis improvement—even with a smaller patient population. This contrasts with epimospermin, whose p-value for the composite endpoint was 0.07, falling short of statistical significance. As the pharmaceutical industry is currently seeing a trend where advance payments account for about 6% of total contract value, the company believes it can demand more favorable terms given that it has cleared the high regulatory hurdle of tissue biopsy.

Regarding the technology transfer strategy, CEO Lee stated, “We are seeking a partner capable of developing the product most quickly and efficiently,” adding, “Our primary goal is to find a partner capable of conducting global clinical trials simultaneously and achieving rapid commercialization.” He further noted, “We are proceeding by comprehensively considering partners optimized for product development and those who can provide the greatest benefit to the company.”

The partnering schedule has also been finalized. CEO Lee announced plans to attend an international conference specializing in MASH and obesity treatments later this month to directly share the AI analysis results for DD01 with big pharma and receive feedback.