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Eilean Therapeutics Receives FDA Clearance for IND Application of Lomonitinib in Treating Acute Myeloid Leukemia

Tuesday, June 11, 2024

Eilean Therapeutics LLC is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for lomonitinib (ZE46-0134). This approval allows the company to start a Phase 1 clinical trial in the United States for FLT3 mutated relapsed/refractory (R/R) acute myeloid leukemia (AML). The trial has already begun in Australia, and with FDA clearance, it can now proceed in the U.S. Lomonitinib is a potent and selective pan-FLT3/IRAK4 inhibitor that targets significant FLT3 mutations and potential escape pathways. "This is a key milestone for Eilean Therapeutics and confirms our strategic drug discovery collaboration with Expert Systems," said Iain Dukes, Chief Executive Officer of Eilean Therapeutics. "We are eager to initiate our clinical trial in the U.S. and further our global efforts to develop a targeted treatment for FLT3 mutated AML."

Lomonitinib is a highly potent and selective inhibitor that targets FLT3 ITD, TKD, and other important 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, known as the "gatekeeper" mutation, which causes resistance to all currently approved FLT3 inhibitors, and the activation of the IRAK4 escape pathway. Lomonitinib inhibits both resistance mechanisms. With an excellent safety profile (no cytological changes) and the ability to quickly achieve steady state and target engagement exposures in a healthy volunteer study, lomonitinib is anticipated to provide deeper responses (more CR/CRh) and longer response durations in R/R AML patients. It is expected to become the best-in-class FLT3 inhibitor.



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