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).

韩国京畿道和马里兰州盖瑟斯堡（BUSINESS WIRE）--D＆D Pharmatech，Inc.（D＆D）（KOSDAQ:347850），一家专注于疾病缓解药物开发的临床阶段生物技术公司，今天宣布，在一项旨在评估DD01在代谢功能障碍相关脂肪性肝病（MASLD）/代谢功能障碍相关脂肪性肝炎（MASH）超重/肥胖受试者中的疗效和安全性的2期试验中开始给药。

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..

DD01是一种长效的双重GLP-1/胰高血糖素受体激动剂，以前被证明可以快速解决脂肪肝患者的肝脏脂肪变性，改善血糖控制并减轻体重。。

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.

这项2期试验是一项随机，双盲，安慰剂对照，活检驱动的研究，正在美国大约12个地点进行。该试验将招募大约68名经活检证实为MASH或MASLD的肥胖/超重受试者（BMI≥25kg/m2）。受试者将以1:1的比例随机接受40 mg DD01或安慰剂，每周一次，持续48周。

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.

D＆D先前在超重/肥胖2型糖尿病（T2D）和MASLD患者的1期多重递增剂量（MAD）研究中报告了DD01的阳性安全性和有效性结果。DD01通常安全且耐受性良好，剂量高达80 mg，每周一次，仅治疗4周后，高达100%的患者通过MRI-PDFF实现肝脏脂肪减少>30%，平均相对减少>50%在40 mg和80 mg剂量的DD01的汇总分析中肝脏脂肪含量。

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..

脂肪变性的这些快速改善伴随着糖尿病受试者中HbA1c的降低，肝脏AST/ALT的降低和血脂的降低。在为期4周的治疗期间，接受剂量为40和80 mg的DD01治疗的受试者显示出适度体重减轻的证据，而接受安慰剂治疗的受试者则没有。。

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.

肥胖小鼠和猴子的临床前研究支持了试验结果，表明DD01治疗在刺激肝脏脂肪减少和体重减轻方面比单独的饮食或GLP-1治疗更有效。。

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..

MASH分辨率在临床前模型中很明显，包括肝脏脂肪变性，小叶炎症，肝细胞气球样变和纤维化迹象的减少，并伴有减少。美国FDA已批准DD01用于治疗MASLD/MASH成人的快速通道。。

“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.

D＆D Pharmatech总裁兼首席执行官Seulki Lee博士表示：“我们很高兴宣布DD01第二阶段研究的启动，这是DD01 for MASH开发的一个重要里程碑。”。“最近的临床研究表明，GLP-1和肝脏导向的胰高血糖素受体的双重激动作用比没有胰高血糖素激动作用的GLP-1类似物更有效地治疗MASH。

About DD01

关于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是一种专有的每周一次的GLP-1（胰高血糖素样肽-1）和胰高血糖素受体双重激动剂，在肥胖/超重的T2D和MASLD患者中半衰期为7-8天。DD01的关键区别在于其双途径作用机制。与其他仅通过肠降血糖素途径起作用的单一和双重激动剂不同，DD01增强了肠降血糖素治疗通过肝脏定向胰高血糖素受体起作用并增强肝脏脂解作用的益处，从而产生快速有效性和先治疗肝脏的潜力。

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..

DD01治疗仅在MAFLD患者的治疗4周内即可快速且临床上显着降低肝脏脂肪。在临床前研究中，DD01在肥胖，糖尿病和脂肪肝的各种临床前模型（包括非人灵长类动物）中引起了显着的体重减轻，肝脏脂肪减少和纤维化，并改善了葡萄糖耐量。。

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.

D＆D Pharmatech是一家临床阶段的生物制药公司，专注于开发用于治疗代谢，纤维化和神经退行性疾病患者的进化药物。D＆D的研发活动利用其在开发长效和口服活性肽药物方面的专业知识，同时专注于肠促胰岛素。

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.

该公司的管道包括DD01，一种GLP-1/胰高血糖素双受体激动剂，正在第二阶段研究中开发用于治疗肥胖和MASH。该公司已经完成了一项针对早期未经治疗的帕金森病患者的长效GLP-1激动剂NLY01的2期研究，证明对60岁以下的患者具有统计学上显着的有益效果。

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..

该公司还正在开发各种口服活性肠降血糖素多肽药物治疗肥胖症。在纤维化领域，该公司正在开发TLY012，一种靶向肌成纤维细胞的工程重组人TRAIL。TLY012逆转了肝脏、胰腺和皮肤纤维化疾病临床前模型中已建立的纤维化。。