GYEONGGI-DO, South Korea & GAITHERSBURG, Md.--(BUSINESS WIRE)--D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH).

韩国京畿道和马里兰州盖瑟斯堡--（商业新闻短讯）--D＆D Pharmatech，Inc.（D＆D），一家专注于开发疾病缓解药物的临床阶段生物技术公司，今天宣布，美国食品和药物管理局（FDA）已授予DD01快速通道指定，用于治疗成人非酒精性脂肪性肝炎（NASH），也称为代谢功能障碍相关脂肪性肝炎（MASH）。

FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases..

FDA快速通道指定旨在通过促进开发和加速审查满足严重疾病未满足需求的药物，更快地为患者带来有前景的药物。。

The FDA based its decision on data from Phase 1, a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of DD01 in overweight/obese subjects with type 2 diabetes (T2D) and metabolic dysfunction-associated fatty liver disease (MAFLD). In that study, DD01 treatment was well tolerated and reduced hepatic steatosis by >50% in only 4 weeks with up to 100% of subjects achieving ≥30% liver fat reduction by MRI-PDFF.

FDA的决定基于第一阶段的数据，这是一项随机，双盲，安慰剂对照研究，评估DD01在超重/肥胖2型糖尿病（T2D）和代谢功能障碍相关脂肪肝（MAFLD）患者中的安全性和有效性。在该研究中，DD01治疗耐受性良好，仅在4周内肝脂肪变性减少>50%，高达100%的受试者通过MRI-PDFF实现肝脏脂肪减少≥30%。

In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH. Weight loss and improved glycemic control were also observed. For many patients, co-occurring type 2 diabetes and obesity are underlying factors. Preclinical and clinical results suggest DD01 treatment may be beneficial in the treatment of fatty liver disease and can improve glycemic control and weight loss in subjects who are overweight or have type 2 diabetes..

在动物模型中，DD01治疗减少了肝脂肪变性，小叶炎症，气球样变和纤维化迹象，所有关键的诊断标准都是MASH。还观察到体重减轻和血糖控制改善。对于许多患者来说，同时发生的2型糖尿病和肥胖是潜在因素。临床前和临床结果表明，DD01治疗可能对脂肪肝疾病的治疗有益，并且可以改善超重或患有2型糖尿病的受试者的血糖控制和体重减轻。。

“We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D. “MASH has a significant unmet need. Multiple clinical trials have recently proven that efficiently reducing excessive liver fat content leads to ameliorating MASH and liver scarring.

D＆D首席执行官Seulki Lee博士说：“我们很高兴FDA决定批准DD01的快速通道指定，并期待在活检证实的MASH患者中启动第二阶段研究。”MASH有一个显着的未满足需求。最近的多项临床试验证明，有效降低肝脏脂肪含量可以改善MASH和肝脏瘢痕形成。

DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.”.

DD01可快速减少肝脏脂肪，并对血糖控制有益；因此，我们预计在即将到来的第二阶段延长治疗后，将在活检证实的MASH患者中进一步研究DD01。”。

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 MAFLD. 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 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MAFLD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。。

About D&D Pharmatech

关于D＆D Pharmatech

D&D Pharmatech is a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty. This corporate structure creates a unique opportunity to accelerate the translation of cutting-edge research into lifesaving therapeutic products for patients.

D＆D Pharmatech是一家临床阶段的全球生物技术公司，通过由顶级医学研究人员创建和指导的针对特定疾病的子公司，为革命性药物的开发提供资金。这种公司结构为加速将尖端研究转化为患者的救生治疗产品创造了独特的机会。

The company’s product pipeline focuses on metabolic diseases, including obesity, MASH and fibrosis, and neurodegenerative diseases. For more information, please visit http://www.ddpharmatech.com/..

该公司的产品线专注于代谢性疾病，包括肥胖，糖化和纤维化以及神经退行性疾病。有关更多信息，请访问http://www.ddpharmatech.com/..

Neuraly Inc. is a wholly owned US subsidiary of D&D Pharmatech.

Neuraly Inc.是D＆D Pharmatech在美国的全资子公司。