15-PGDH

“ 点击蓝字 关注我们 人福医药化药1类新药HW201877胶囊获批临床 PPS  近日，人福医药集团旗下武汉人福创新药物研发中心有限公司获得国家药品监督管理局核准签发的HW201877胶囊的《药物临床试验批准通知书》，批准开展用于治疗炎症性肠病的临床试验。该品种的获批标志着集团在消化系统疾病创新药研发领域取得重要突破。 作为国内首个进入临床阶段的15-PGDH抑制剂，HW201877通过特异性抑制靶酶活性，显著提升肠道组织中PGE2的水平。升高的PGE2通过作用于EP4受体激活cAMP-PKA信号通路，双重调控机制实现：一方面促进肠道干细胞增殖与上皮屏障修复，另一方面抑制促炎因子释放，在动物模型中展现出剂量依赖性的黏膜修复和抗炎效果。临床前数据显示，该化合物具有优异的药代特性和安全性。 HW201877胶囊是由人福医药集团医药研究院自主研究开发的1类新药，其研发基于靶点蛋白结构的理性药物设计。医药研究院药物化学团队针对15-PGDH酶的晶体结构特征，采用计算机辅助药物设计技术，通过系统性的构效关系研究和多轮结构优化，最终确立了具有很好成药性和显著药效优势的临床前备选化合物HW201877。集团医药研究院完成药学、药理毒理研究、临床设计及注册申报等工作，于2024年12月向国家药品监督管理局药品审评中心提交临床试验申请并获得受理。 产品临床试验的获批，将进一步丰富人福医药集团在自免领域和消化系统疾病领域的创新产品管线。公司将加快推进HW201877胶囊的临床研究相关工作，为炎症性肠病患者带来更多的治疗选择。 文章来源：人福医药 美编排版：朱玲欣 文章审核：朱玲欣 罗琪 周碧远 【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。 《药学进展》杂志由国家教育部主管、中国药科大学和中国药学会共同主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。 《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。 《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。 联系《药学进展》↓↓↓ 编辑部官网：pps.cpu.edu.cn； 邮箱：yxjz@163.com； 电话：025-83271227。 欢迎投稿、订阅！ 往期推荐 聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航 我知道你在看哟

Company expects to share preliminary Phase 1 clinical data in the second half of 2025 SAN DIEGO, CA, USA I January 30, 2025 I Epirium Bio, Inc. (Epirium), a biopharmaceutical company advancing medicines for neuromuscular and fibrotic diseases, today announced that it has initiated dosing of healthy volunteers in its Phase 1 dose-escalation clinical trial of MF-300, an investigational, first-in-class, orally administered,15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor in development for the treatment of sarcopenia, or age-induced muscle weakness. It is estimated that up to a third of Americans over the age of 60 are affected by sarcopenia, a disease that increases the risk of falls, fractures, disability and all-cause mortality. Despite sarcopenia’s widespread prevalence and serious health implications, there are currently no FDA-approved therapies available to treat sarcopenia, highlighting the significant unmet medical need for this disease. “Dosing our first participants with MF-300, is a significant achievement and marks an important milestone for Epirium in our successful transition to a clinical-stage company developing an oral therapy for the over 20 million elderly Americans estimated to suffer from sarcopenia,” said Alex Casdin, Chief Executive Officer of Epirium. “I’m deeply grateful to our team and the study’s participants. The results of this Phase 1 trial will provide Epirium with important insights into the safety and pharmacological profile of MF-300, as well as valuable target engagement data. These results have the potential to represent a key step forward in advancing MF-300 as a first-in-class oral therapy for patients with sarcopenia.” About the MF-300 Phase 1 Clinical Trial The Phase 1 clinical trial is a two-part, randomized, double-blind, placebo controlled, dose-escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of single (Part 1) and multiple ascending doses (Part 2) of MF-300. The Company anticipates reporting topline results in the second half of 2025. About MF-300 MF-300 is an investigational, orally bioavailable small molecule that reversibly binds to the prostaglandin E2 (PGE2) binding site of 15-hydroxyprostaglandin dehydrogenase (15-PGDH), inhibiting 15-PGDH activity and increasing physiologic levels of PGE2 in skeletal muscle in preclinical studies and raising PGE2 levels in cell-based assays. PGE2 plays a crucial role in promoting aged muscle strength by improving underlying muscle quality (i.e., muscle strength independent of muscle mass) as well as function of the neuromuscular junction in preclinical studies of aged mice. 15-PGDH, an enzyme that converts PGE2 to an inactive metabolite, is upregulated at the level of gene expression in muscle of aged humans and rodents coinciding with age-induced muscle weakness. Inhibiting 15-PGDH in aged muscle may be a strategy to increase physiologic levels of PGE2 to improve muscle quality and function in sarcopenia. About Epirium Bio Epirium, a biopharmaceutical company based in San Diego, California, has identified and established an IP-protected platform of orally bioavailable small molecules that constitute a new class of therapeutics with the potential to improve function in neuromuscular diseases, including sarcopenia and spinal muscular atrophy. Epirium has generated preclinical data in a broader scope of indications with significant unmet medical need, including fibrosis, which Epirium’s development pipeline has the potential to address. To learn more about Epirium, please visit www.epirium.com and follow us on LinkedIn . SOURCE: Epirium Bio

SAN DIEGO--( BUSINESS WIRE )--Epirium Bio, Inc. (Epirium), a biopharmaceutical company advancing medicines for neuromuscular and fibrotic diseases, today announced that it has initiated dosing of healthy volunteers in its Phase 1 dose-escalation clinical trial of MF-300, an investigational, first-in-class, orally administered,15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor in development for the treatment of sarcopenia, or age-induced muscle weakness. It is estimated that up to a third of Americans over the age of 60 are affected by sarcopenia, a disease that increases the risk of falls, fractures, disability and all-cause mortality. Despite sarcopenia’s widespread prevalence and serious health implications, there are currently no FDA-approved therapies available to treat sarcopenia, highlighting the significant unmet medical need for this disease. “ Dosing our first participants with MF-300, is a significant achievement and marks an important milestone for Epirium in our successful transition to a clinical-stage company developing an oral therapy for the over 20 million elderly Americans estimated to suffer from sarcopenia,” said Alex Casdin, Chief Executive Officer of Epirium. “ I’m deeply grateful to our team and the study’s participants. The results of this Phase 1 trial will provide Epirium with important insights into the safety and pharmacological profile of MF-300, as well as valuable target engagement data. These results have the potential to represent a key step forward in advancing MF-300 as a first-in-class oral therapy for patients with sarcopenia.” About the MF-300 Phase 1 Clinical Trial The Phase 1 clinical trial is a two-part, randomized, double-blind, placebo controlled, dose-escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of single (Part 1) and multiple ascending doses (Part 2) of MF-300. The Company anticipates reporting topline results in the second half of 2025. About MF-300 MF-300 is an investigational, orally bioavailable small molecule that reversibly binds to the prostaglandin E2 (PGE2) binding site of 15-hydroxyprostaglandin dehydrogenase (15-PGDH), inhibiting 15-PGDH activity and increasing physiologic levels of PGE2 in skeletal muscle in preclinical studies and raising PGE2 levels in cell-based assays. PGE2 plays a crucial role in promoting aged muscle strength by improving underlying muscle quality (i.e., muscle strength independent of muscle mass) as well as function of the neuromuscular junction in preclinical studies of aged mice. 15-PGDH, an enzyme that converts PGE2 to an inactive metabolite, is upregulated at the level of gene expression in muscle of aged humans and rodents coinciding with age-induced muscle weakness. Inhibiting 15-PGDH in aged muscle may be a strategy to increase physiologic levels of PGE2 to improve muscle quality and function in sarcopenia. About Epirium Bio Epirium, a biopharmaceutical company based in San Diego, California, has identified and established an IP-protected platform of orally bioavailable small molecules that constitute a new class of therapeutics with the potential to improve function in neuromuscular diseases, including sarcopenia and spinal muscular atrophy. Epirium has generated preclinical data in a broader scope of indications with significant unmet medical need, including fibrosis, which Epirium’s development pipeline has the potential to address. To learn more about Epirium, please visit www.epirium.com and follow us on LinkedIn .