DOVER, Del., June 10, 2024 /PRNewswire/ -- Eilean Therapeutics LLC, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the IND for lomonitinib (ZE46-0134), allowing the company to proceed with a Phase 1 clinical trial in FLT3 mutated relapsed/refractory (R/R) AML.  While the Phase 1 study has already initiated in Australia, clearance from the FDA will allow the trial to be initiated in the US.

多佛，Del。，2024年6月10日/PRNewswire/--Eilean Therapeutics LLC很高兴地宣布，美国食品和药物管理局（FDA）已经批准了洛莫替尼（ZE46-0134）的IND，允许该公司进行FLT3突变复发/难治性（R/R）AML的1期临床试验。虽然第一阶段研究已经在澳大利亚启动，但FDA的批准将允许该试验在美国启动。

Lomonitinib is a highly potent and selective pan-FLT3/IRAK4 inhibitor that targets clinically relevant FLT3 mutations and putative escape pathways. 'This is a major milestone for Eilean Therapeutics and validates our rational drug discovery approach with our collaborator Expert Systems,' commented Iain Dukes, Chief Executive Officer of Eilean Therapeutics.

洛莫替尼是一种高效且选择性的泛FLT3/IRAK4抑制剂，可靶向临床相关的FLT3突变和推定的逃逸途径。”艾琳治疗首席执行官伊恩·杜克斯（IainDukes）评论说，这是艾琳治疗的一个重要里程碑，并通过我们的合作者专家系统验证了我们的合理药物发现方法。

'We are looking forward to getting our clinical trial underway in the US and further expanding our global trial testing a targeted approach to treating FLT3 mutated AML.'.

“我们期待着在美国进行临床试验，并进一步扩大我们的全球试验测试，以有针对性地治疗FLT3突变的AML。”。

About LomonitinibLomonitinib is a highly potent and selective inhibitor of FLT3 ITD, TKD and other clinically relevant FLT3 mutations, as well as IRAK4. FLT3 mutations are the most frequently identified mutations in AML. There are two main mechanisms of resistance to FLT3 inhibitors: the FLT3-ITD-F691L mutation deemed the 'gatekeeper' mutation that confers resistance to all currently approved FLT3 inhibitors and the activation of the IRAK4 escape pathway.

关于LomonitinibLomonitinib是FLT3 ITD，TKD和其他临床相关FLT3突变以及IRAK4的高效选择性抑制剂。FLT3突变是AML中最常见的突变。对FLT3抑制剂的抗性有两种主要机制：FLT3-ITD-F691L突变被认为是“看门人”突变，赋予对所有目前批准的FLT3抑制剂的抗性和IRAK4逃逸途径的激活。

Lomonitinib inhibits both resistance mechanisms. Given the excellent safety profile (with no cytological changes) and ability to rapidly reach steady state, target engagement exposures in a healthy volunteer study, it is anticipated that lomonitinib will have a deeper response (i.e. more CR/CRh) and longer duration of response in R/R AML patients, and eventually expand to be the best-in-class FLT3 inhibitor.  .

洛莫替尼抑制两种耐药机制。鉴于在健康志愿者研究中具有良好的安全性（无细胞学变化）和快速达到稳定状态的能力，目标参与暴露，预计洛莫替尼将在R/R AML患者中产生更深的反应（即更多的CR/CRh）和更长的反应持续时间，并最终扩展为同类最佳的FLT3抑制剂。。

About Eilean TherapeuticsEilean Therapeutics LLC is a biopharmaceutical company co-founded by OrbiMed, Torrey Pines Investment and Dr. John C. Byrd, focused on the discovery and development of best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers.

关于Eilean Therapeutics LLC Eilean Therapeutics LLC是一家由OrbiMed，Torrey Pines Investment和John C.Byrd博士共同创立的生物制药公司，专注于发现和开发针对血液学和实体癌逃逸突变的一流小分子抑制剂。

The company is utilizing a proprietary hybrid AI (Expert Systems Inc.), leveraging its key partners proprietary data, chem/bio tools, knowledge and expertise to choose highly valuable molecular mechanism of pathology, to rationally design, accelerate discovery and optimize development of best-in-class and first-in-class therapies.

该公司正在利用专有的混合AI（Expert Systems Inc.），利用其关键合作伙伴的专有数据，化学/生物工具，知识和专业知识来选择极具价值的病理分子机制，以合理设计，加速发现和优化一流和一流疗法的开发。

Eilean Therapeutics' goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to maximize the clinical benefit when treating hematologic and solid malignancies. For more information visit www.eileanther.com.

Eilean Therapeutics的目标是利用其能力和平台成为开发新型突破性药物的领导者，以最大限度地提高治疗血液和实体恶性肿瘤的临床效益。有关更多信息，请访问www.eileanther.com。