[NA Eun-kyung, Edaily Reporter] SEOUL , June 16, 2025. D&D Pharmatech, a developer of glucagon-like peptide-1(GLP-1)-based therapies, announced that its investigational treatment for metabolic dysfunction-associated steatohepatitis(MASH), DD01, achieved statistically significant results in its ongoing Phase 2 trial in the United States.

According to interim data disclosed Monday, 75.8% (25 out of 33) of patients in the DD01 treatment group experienced at least a 30% reduction in liver fat, compared with 11.8% in the placebo group (p<0.0001). The mean liver fat reduction at week 12 was 62.3% for DD01, versus 8.3% for placebo.

These outcomes were based on a conservative intention-to-treat analysis that included patients who discontinued treatment. Among those who completed the full 12-week dosing protocol and underwent MRI-PDFF assessment, the mean liver fat reduction reached 67.3%, and 85.7% achieved over 30% liver fat reduction.

Comparable to Survodutide in One-Fourth the Time

D&D emphasized that DD01 matched or exceeded the efficacy of Boehringer Ingelheim’s GLP-1/glucagon dual agonist survodutide, which has shown leading anti-fibrotic potential in the MASH space. Survodutide, in a Phase 2 study completed last year, showed a 76.9% responder rate and 64.3% mean fat reduction after 48 weeks at a 6 mg dose. DD01 achieved similar efficacy in just 12 weeks.

The safety profile of DD01 was also favorable. Only three patients (9.09%) in the treatment group discontinued due to gastrointestinal side effects―despite a shorter 2-week dose-escalation period, compared to survodutide’s 24-week protocol.

DD01 also produced high response rates in stricter liver fat reduction categories: 72.7% of patients saw over 50% reduction, 57.6% over 70%, and 48.5% achieved normalization of liver fat content (≤5%) in just 12 weeks (p<0.0001 vs. placebo).

Beyond liver fat reduction, DD01 demonstrated statistically significant improvements in non-invasive fibrosis markers, body weight, and glycemic control. Notably, 42.4% of DD01-treated patients lost more than 5% of their body weight, compared with minimal change in the placebo group.

◇Lead Investigator Highlights Promise for FDA Approval

“This trial confirmed the striking liver fat reduction effect of DD01,” said Dr. Mazen Noureddin, principal investigator of the study and a globally recognized expert in MASH. “Achieving over 30% liver fat reduction in more than 75% of patients―and normalization in nearly half―in just 12 weeks is extremely encouraging.”

Dr. Noureddin added that DD01’s biological activity aligns with its mechanism of action and supports potential to meet U.S. FDA approval criteria for MASH, including fibrosis improvement and MASH resolution. He has previously led more than 50 clinical trials, including those for Madrigal’s FDA-approved resmetirom.

Positioned for Global Licensing Deals

To facilitate global partnerships, D&D recently signed a strategic consulting agreement with a leading U.S. investment bank. The company plans to initiate license-out discussions based on these Phase 2 results.

Interest in MASH treatments has surged among global pharmaceutical companies. In May, GlaxoSmithKline signed a licensing deal worth up to $2 billion (KRW 3.7 trillion) for efinosfermin, a drug with a 59.6% mean liver fat reduction after 12 weeks. D&D believes DD01’s superior efficacy could drive a similarly sizable deal.

D&D will continue the trial through 48 weeks, followed by liver biopsies to evaluate fibrosis improvement and MASH resolution, in line with FDA approval endpoints. Full 48-week dosing is expected to conclude by the end of this year, with biopsy results anticipated in the first half of 2026.

The ongoing Phase 2 trial is a randomized, double-blind, placebo-controlled study involving 67 patients with MASH and BMI ≥25㎏/㎡, across 12 U.S. clinical sites. Patients were assigned to receive DD01(n=33) or placebo (n=34). The primary endpoint was the proportion of patients with ≥30% liver fat reduction at week 12, assessed via MRI-PDFF.

“We are pleased with the rapid liver fat reduction seen over just 12 weeks,” said Seulgi Lee, CEO of D&D Pharmatech. “With growing global interest in MASH therapies, we are committed to pursuing large-scale licensing deals based on this competitive clinical profile.”

D&D will hold an analyst and investor briefing on the trial results and is preparing to present the data at a major international medical congress in the second half of this year.

나은경 (eeee@edaily.co.kr)

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