DD-01

▎Armstrong 2024年9月24日，Mersera公布长效GLP-1受体激动剂MET-097的最新临床数据，半衰期约380小时（16天），为司美格鲁肽等GLP-1类产品的2-3倍，未来有望实现每月一针。此次公布的一期临床，单词给药从0.16mg爬坡至1.6mg，多次给药从0.2mg爬坡至1.2mg，五次给药且没有采取滴定过程。1.2mg剂量组治疗5周后减重7.5%，最后一次停药后4周减重幅度扩大到8.1%，提示药效保持时间与超长半衰期相符合。 Metsera计划今年四季度启动2b期临床，2025年上半年获得顶线数据。 Metsera于今年4月走出隐匿模式，并宣布已完成2.9亿美元融资，游Population Health Partners、ARCH Venture Partners创立，管理团队方面，首席执行官是Clive Meanwell，他曾是The Medicines Company 的首席执行官。 Metsera的6款研发管线全部从韩国生物技术公司DD  Pharmatech引进，包括DD01（GLP-1/GCG）、DD02S（口服GLP-1）、DD03（口服GLP-1/GIP/GCG）、DD07（口服胰淀素类似物）、DD14（口服GLP-1/GIP）、DD15（GLP-1/GIP/GCG）。 总结 Metsera选择了一条差异化路径，从超长效GLP-1入手，希望实现每个月一针的给药频率。疗效上，1.2mg MET-097的减重效果媲美目前的双靶点产品，期待其后续临床进展。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理； 补体靶向药物技术全梳理； 补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理； 靶点冷暖，行业自知； 中国大分子新药研发格局； 被炮轰的“me too”； 佐剂百年史； 胰岛素百年传奇； CUSBEA：风雨四十载； 中国新药研发的焦虑； 中国生物医药企业的研发竞争； 中国双抗竞争格局； 中国ADC竞争格局； 中国双抗技术全梳理； 中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理； 亘喜生物技术全梳理； 康哲药业技术全梳理； 科济药业技术全梳理； 恺佧生物技术全梳理； 同宜医药技术全梳理； 百奥赛图技术全梳理； 腾盛博药技术全梳理； 创胜集团技术全梳理； 永泰生物技术全梳理； 中国抗体技术全梳理； 德琪医药技术全梳理； 德琪医药技术全梳理2.0； 和铂医药技术全梳理； 荣昌生物技术全梳理； 再鼎医药技术全梳理； 药明生物技术全梳理； 恒瑞医药技术全梳理； 豪森药业技术全梳理； 正大天晴技术全梳理； 吉凯基因技术全梳理； 基石药业技术全梳理； 百济神州技术全梳理； 百济神州技术全梳理第2版； 信达生物技术全梳理； 信达生物技术全梳理第2版； 中山康方技术全梳理； 复宏汉霖技术全梳理； 先声药业技术全梳理； 君实生物技术全梳理； 嘉和生物技术全梳理； 志道生物技术全梳理； 道尔生物技术全梳理； 尚健生物技术全梳理； 康宁杰瑞技术全梳理； 科望医药技术全梳理； 科望医药技术全梳理2.0； 岸迈生物技术全梳理； 礼进生物技术全梳理； 康桥资本技术全梳理； 余国良的抗体药布局； 荃信生物技术全梳理； 安源医药技术全梳理； 三生国健技术全梳理； 仁会生物技术全梳理； 乐普生物技术全梳理； 同润生物技术全梳理； 宜明昂科技术全梳理； 派格生物技术全梳理； 迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理； 普米斯生物技术全梳理； 普米斯生物技术全梳理2.0； 三叶草生物技术全梳理； 贝达药业抗体药全梳理； 泽璟制药抗体药全梳理； 恒瑞医药抗体药全梳理； 齐鲁制药抗体药全梳理； 石药集团抗体药全梳理； 豪森药业抗体药全梳理； 华海药业抗体药全梳理； 科伦药业抗体药全梳理； 百奥泰技术全梳理； 凡恩世技术全梳理。

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.