
D&D Pharmatech a clinical-stage biotechnology company dedicated to the development of disease-modifying therapeutics, has announced the successful completion of patient enrollment for DD01-DN-2, an ongoing Phase 2 clinical trial. This trial is designed to assess the efficacy and safety of DD01, a liver-targeted, long-acting, dual GLP-1/glucagon receptor agonist, in overweight and obese patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) through biopsy confirmation.
Overview of DD01 and its Potential in MASH Treatment
DD01 Pharmatech has been engineered as a novel therapy with the ability to rapidly resolve hepatic steatosis, improve glycemic control, and reduce body weight in individuals suffering from fatty liver disease. Unlike other investigational treatments for MASH, DD01 does not require a prolonged titration phase to reach therapeutic levels, which could provide significant advantages in terms of patient adherence and treatment efficacy.
The U.S. Food and Drug Administration (FDA) has recognized the potential of DD01 Pharmatech and has granted it Fast Track designation for the treatment of adults with MASH. This designation underscores the urgent need for effective therapies for MASH, a progressive liver disease associated with inflammation, fibrosis, and a high risk of cirrhosis and liver-related complications.
Details of the Phase 2 DD01-DN-2 Trial
The DD01-DN-2 Pharmatech study is a randomized, double-blind, placebo-controlled Phase 2 trial spanning 48 weeks. Participants receive a weekly 40 mg dose of DD01, with efficacy and safety assessments occurring at multiple points throughout the study. The primary endpoint of the trial focuses on changes in liver fat content as measured by MRI-PDFF at 12 weeks, while secondary and exploratory endpoints include:
- MASH Resolution and Fibrosis Improvement: Evaluation of histological changes at 48 weeks.
- Glycemic Control: Assessment of changes in HbA1c levels.
- Weight Loss: Monitoring of reductions in body weight, which is a critical factor in the management of MASH.
- Liver Function and Biomarker Analysis: Measurement of liver enzymes (AST, ALT), lipid profiles, and inflammatory markers to further understand DD01’s therapeutic impact.
Promising Preliminary Data from Early Trials
A previously conducted proof-of-concept study provided promising results regarding DD01’s potential benefits. In that study, overweight and obese patients diagnosed with Type 2 diabetes (T2D) and metabolic dysfunction-associated steatotic liver disease (MASLD) tolerated DD01 well. Notably, after just four weeks of treatment:
- Patients receiving 40 mg and 80 mg doses of DD01 experienced a mean relative reduction of more than 50% in liver fat content as measured by MRI-PDFF.
- HbA1c levels demonstrated a marked decrease, suggesting improved glycemic control.
- Liver enzymes (AST/ALT) and serum lipids showed significant reductions.
- Participants exhibited modest weight loss, reinforcing the dual benefits of DD01 in metabolic and hepatic health.
Statements from Leadership
Dr. Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech, expressed optimism about the trial’s potential impact:
“We are pleased to report that we have completed enrollment in our Phase 2 trial investigating DD01 in MASH patients. Based on clinical and preclinical studies completed to date, we expect this study to confirm best-in-class potential for DD01 in MASH with long-term treatment accompanied by three key beneficial effects – rapid and robust reductions in liver fat, glucose control, and weight loss leading to clinically significant rates of MASH resolution and fibrosis improvement without the need for the lengthy titration phase.”
The Growing Burden of MASH and the Need for Effective Treatments
Pharmatech MASH is a major global health concern, with prevalence increasing due to rising rates of obesity, metabolic syndrome, and Type 2 diabetes. The disease is characterized by excessive fat accumulation in the liver, inflammation, and progressive fibrosis, which can lead to cirrhosis, liver failure, and an increased risk of cardiovascular disease. Despite its growing prevalence, no FDA-approved pharmacological treatments for MASH currently exist, creating an urgent need for effective therapies such as DD01.
Next Steps and Future Outlook
With patient enrollment now complete, D&D Pharmatech is focused on completing the study’s next phases. Top-line results from the 12-week efficacy and safety evaluation are expected in late Q2 2025, providing crucial insights into the potential of DD01 as a transformative treatment for MASH.
If the data from this Phase 2 study are positive, D&D Pharmatech intends to progress DD01 into larger Phase 3 trials to further validate its efficacy and safety. This could eventually lead to regulatory approvals and market availability, offering new hope for millions of patients worldwide who suffer from this debilitating disease.