NLY-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 dosing has commenced in a Phase 2 trial designed to evaluate the efficacy and safety of DD01 in overweight/obese subjects with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH). DD01 is a 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. This Phase 2 trial is a randomized, double-blind, placebo-controlled, biopsy-driven study being conducted at approximately 12 sites in the United States. The trial will enroll approximately 68 obese/overweight subjects (BMI ≥25kg/m2) with biopsy-confirmed MASH or MASLD. Subjects will be randomized 1:1 to receive either 40 mg DD01 or placebo once weekly for 48 weeks. The primary endpoint of the study is the proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF from baseline to Week 12, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures, including MASH resolution, fibrosis improvement, HbA1c, and body weight, with dosing continuing for a total of 48 weeks. D&D previously reported positive safety and efficacy results for DD01 in a Phase 1 multiple ascending dose (MAD) study in overweight/obese patients with type 2 diabetes (T2D) and MASLD. DD01 was generally safe and well-tolerated at doses up to 80 mg once weekly and, following only 4 weeks of treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF with a mean relative reduction of >50% liver fat content in a pooled analysis of 40 mg and 80 mg doses of DD01. These rapid improvements in steatosis were accompanied by decreased HbA1c in diabetic subjects, reduced liver AST/ALT, and serum lipids. Over the 4-week treatment period, subjects treated with DD01 at doses of 40 and 80 mg showed evidence of modest weight loss while placebo-treated subjects did not. Trial results are supported by preclinical studies in obese mice and monkeys showing that DD01 treatment is more effective than diet or GLP-1 treatment alone in stimulating liver fat reduction and weight loss. The lipolytic effects of glucagon are preserved and balanced with the anorectic and anti-diabetic effects of GLP-1, resulting in a true dual-pathway treatment. MASH resolution was evident in pre-clinical models and included reductions in liver steatosis, lobular inflammation, hepatocyte ballooning, and signs of fibrosis, which were accompanied by reductions. The US FDA has granted Fast Track designation to DD01 for the treatment of adults with MASLD/MASH. “We are excited to announce the initiation of the DD01 Phase 2 study, which represents an important milestone in the development of DD01 for MASH,” said Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech. “Recent clinical studies suggest that dual agonism of GLP-1 and liver-directed glucagon receptors would be more effective for treating MASH than GLP-1 analogs without glucagon agonism. As DD01 already achieved rapid and robust reductions in hepatic steatosis with beneficial effects on glucose control following only 4 weeks of treatment, we are looking forward to achieving clinically significant rates of MASH resolution and fibrosis improvement in our Phase 2 trial.” More information about the 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 other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the liver-directed glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment from MAFLD patients. In preclinical studies, DD01 caused significant weight loss, reduced liver fat and fibrosis, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates. About D&D Pharmatech D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing evolutionary medicines for treating patients with metabolic, fibrotic, and neurodegenerative diseases. D&D’s R&D activities leverage its expertise in developing long-acting and orally active peptide drugs while focusing on incretins. The company’s pipelines include DD01, a GLP-1/glucagon dual receptor agonist being developed for treating obesity and MASH in a Phase 2 study. The company has completed a Phase 2 study of NLY01, a long-acting GLP-1 agonist, in patients with early, untreated Parkinson’s disease, demonstrating statistically significant beneficial effects in patients under 60. The company is also developing various orally active incretin-based peptide drugs for obesity. In the fibrotic space, the company is developing TLY012, an engineered recombinant human TRAIL that targets myofibroblasts. TLY012 reversed established fibrosis in preclinical models of the fibrotic disease in liver, pancreas and skin.

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 dosing has commenced in a Phase 2 trial designed to evaluate the efficacy and safety of DD01 in overweight/obese subjects with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH). DD01 is a 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. This Phase 2 trial is a randomized, double-blind, placebo-controlled, biopsy-driven study being conducted at approximately 12 sites in the United States. The trial will enroll approximately 68 obese/overweight subjects (BMI ≥25kg/m2) with biopsy-confirmed MASH or MASLD. Subjects will be randomized 1:1 to receive either 40 mg DD01 or placebo once weekly for 48 weeks. The primary endpoint of the study is the proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF from baseline to Week 12, with secondary and exploratory endpoints evaluating a range of additional safety and efficacy measures, including MASH resolution, fibrosis improvement, HbA1c, and body weight, with dosing continuing for a total of 48 weeks. D&D previously reported positive safety and efficacy results for DD01 in a Phase 1 multiple ascending dose (MAD) study in overweight/obese patients with type 2 diabetes (T2D) and MASLD. DD01 was generally safe and well-tolerated at doses up to 80 mg once weekly and, following only 4 weeks of treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF with a mean relative reduction of >50% liver fat content in a pooled analysis of 40 mg and 80 mg doses of DD01. These rapid improvements in steatosis were accompanied by decreased HbA1c in diabetic subjects, reduced liver AST/ALT, and serum lipids. Over the 4-week treatment period, subjects treated with DD01 at doses of 40 and 80 mg showed evidence of modest weight loss while placebo-treated subjects did not. Trial results are supported by preclinical studies in obese mice and monkeys showing that DD01 treatment is more effective than diet or GLP-1 treatment alone in stimulating liver fat reduction and weight loss. The lipolytic effects of glucagon are preserved and balanced with the anorectic and anti-diabetic effects of GLP-1, resulting in a true dual-pathway treatment. MASH resolution was evident in pre-clinical models and included reductions in liver steatosis, lobular inflammation, hepatocyte ballooning, and signs of fibrosis, which were accompanied by reductions. The US FDA has granted Fast Track designation to DD01 for the treatment of adults with MASLD/MASH. “We are excited to announce the initiation of the DD01 Phase 2 study, which represents an important milestone in the development of DD01 for MASH,” said Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech. “Recent clinical studies suggest that dual agonism of GLP-1 and liver-directed glucagon receptors would be more effective for treating MASH than GLP-1 analogs without glucagon agonism. As DD01 already achieved rapid and robust reductions in hepatic steatosis with beneficial effects on glucose control following only 4 weeks of treatment, we are looking forward to achieving clinically significant rates of MASH resolution and fibrosis improvement in our Phase 2 trial.” More information about the 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 other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the liver-directed glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment from MAFLD patients. In preclinical studies, DD01 caused significant weight loss, reduced liver fat and fibrosis, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates. About D&D Pharmatech D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing evolutionary medicines for treating patients with metabolic, fibrotic, and neurodegenerative diseases. D&D’s R&D activities leverage its expertise in developing long-acting and orally active peptide drugs while focusing on incretins. The company’s pipelines include DD01, a GLP-1/glucagon dual receptor agonist being developed for treating obesity and MASH in a Phase 2 study. The company has completed a Phase 2 study of NLY01, a long-acting GLP-1 agonist, in patients with early, untreated Parkinson’s disease, demonstrating statistically significant beneficial effects in patients under 60. The company is also developing various orally active incretin-based peptide drugs for obesity. In the fibrotic space, the company is developing TLY012, an engineered recombinant human TRAIL that targets myofibroblasts. TLY012 reversed established fibrosis in preclinical models of the fibrotic disease in liver, pancreas and skin.