DD-01

GYEONGGI-DO, South Korea & GAITHERSBURG, Md.--( BUSINESS WIRE )--D&D Pharmatech, Inc. (D&D) (KOSDAQ: 347850), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, today, announced that patient enrollment has been completed for DD01-DN-2, an ongoing Phase 2 trial designed to evaluate the efficacy and safety of DD01 in overweight/obese subjects with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH). DD01 is a liver-targeted, long-acting, dual GLP-1/glucagon receptor agonist previously shown to rapidly resolve hepatic steatosis, improve glycemic control, and reduce body weight in subjects with fatty liver disease. DD01-DN-2 is a randomized, double-blind, placebo-controlled 48-week Phase 2 trial designed to evaluate the efficacy and safety of 40 mg DD01 administered once weekly in obese/overweight subjects with biopsy-confirmed MASH. Study endpoints include an assessment of MRI-PDFF at 12 weeks with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures, including assessment of MASH resolution and fibrosis improvement at 48 weeks, change in HbA1c, and body weight. Unlike other investigational treatments for MASH, DD01 treatment does not require lengthy titration to reach the therapeutic levels commonly associated with these treatments. The top-line 12-week efficacy and safety results will be announced in late Q2 2025. In a previously completed proof-of-concept study, DD01 was well tolerated in overweight/obese patients with Type 2 diabetes (T2D) and metabolic dysfunction-associated steatotic liver disease (MASLD). Following only 4 weeks of treatment, the 40 mg and 80 mg doses resulted in a mean relative reduction of >50% liver fat content by MRI-PDFF along with decreased HbA1c, reduced liver AST/ALT and serum lipids, as well as evidence of modest weight loss. The US FDA has granted Fast Track designation to DD01 for the treatment of adults with MASH. “We are pleased to report that we have completed enrollment in our Phase 2 trial investigating DD01 in MASH patients,” said Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech. “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.” More information about the current study is available at www.clinicaltrials.gov under the identifier NCT06410924. About DD01 DD01 is a proprietary, once-weekly dual agonist of GLP-1 (glucagon-like peptide-1) and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and MASLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike single and dual agonists, which act only through the incretin pathway, DD01 is also a glucagon receptor agonist that provides targeted and rapid reductions in liver fat. From the Phase 1 study, doses that result in liver fat reductions of up to 50% are well tolerated, and meaningful effects on the liver are accompanied by improvements in glucose utilization and weight loss. 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. D&D’s R&D activities leverage expertise in developing long-acting and orally active peptide drugs with a strong pipeline of innovative incretin-based therapies in development for the treatment of liver disease, obesity, and neurodegenerative diseases. The clinical-stage pipeline includes DD01, a GLP-1/glucagon dual receptor agonist being developed for MASH. NLY01, a long-acting GLP-1 agonist, recently completed a 36-week Phase 2 trial in >250 Parkinson’s disease patients, revealing statistically significant beneficial effects in young (<60) patients newly diagnosed with PD. Collaborative efforts to extend these findings to the treatment of other chronic and progressive neurodegenerative diseases, including multiple sclerosis, are an important priority. In partnership with Metsera, the company develops various orally active incretin-based peptide drugs for obesity. Offering a new mechanism for treating fibrotic disease, TLY012 directly targets activated myofibroblasts, the source of fibrosis in cirrhosis, scleroderma, and pancreatitis. TLY012 treatment reverses established fibrosis in models of fibrotic disease, including cirrhotic liver, scleroderma, and chronic pancreatitis. FDA granted orphan drug status for TLY012 in the treatment of fibrosis, and IND-enabling studies were recently completed.