This trial will assess the tolerability, safety, pharmacokinetics, and anti-tumour activity of lomonitinib in R/R AML patients. Credit: Nemes Laszlo / Shutterstock.com.

Eilean Therapeutics has received approval from the Human Research Ethics Committee (HREC) in Australia to commence a Phase I clinical trial of its drug candidate lomonitinib (ZE46-0134) for acute myeloid leukaemia (AML).

This trial is set to assess the tolerability, safety, pharmacokinetics, and anti-tumour activity of lomonitinib when used as a single agent in patients with relapsed/refractory AML (r/r AML) who have FLT3 mutations.

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It will have a dose escalation followed by an expansion phase and will enrol up to 60 participants.

The trial is scheduled to commence in the second quarter of this year, with multiple investigative sites across Australia participating.

Lomonitinib is a selective plan-FLT3/IRAK4 inhibitor designed to target FLT3 mutations prevalent in AML and potential escape pathways.

FLT3 mutations are the most common mutations found in AML patients.

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Resistance to FLT3 inhibitors typically arises through two main mechanisms: the FLT3-ITD-F691L mutation, known as the ‘gatekeeper’ mutation, and the activation of the IRAK4 pathway. Lomonitinib has been developed to inhibit both these resistance mechanisms.

Eilean’s strategy focuses on discovering and developing small molecule inhibitors that act on escape mutations in various cancers.

The company employs hybrid AI from Expert Systems, which utilises data, chemical and biological tools, and expertise to speed up the discovery and optimisation of various therapies.

Eilean Therapeutics CEO Iain Dukes said: “This is a major milestone for the Eilean team, as we continue to progress an accelerated development of lomonitinib.

“Given the safety profile, extended half-life and target engagement demonstrated in a healthy volunteer study, we look forward to initiating our clinical trial and testing our approach in r/r AML patients.”