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FDA Clears IND for Eilean Therapeutics’ Lomonitinib

Clearance from the FDA allows a Phase 1 clinical trial to be initiated in the U.S.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

The U.S. Food and Drug Administration (FDA) has cleared the IND for Eilean Therapeutics’ 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 been initiated in Australia, clearance from the FDA will allow the trial to be initiated in the US.
 
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, CEO of Eilean Therapeutics. “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.”

More Eilean Therapeutics News

In April, Eilean Therapeutics acquired Ness Therapeutics Inc. in an all-equity transaction.

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