Oryzon Genomics is set to commence a Phase Ib clinical trial of iadademstat in individuals with relapsed/refractory acute myeloid leukaemia (R/R AML) harbouring an FMS-like tyrosine kinase mutation (FLT3mut+).

The development comes after the US Food and Drug Administration (FDA) cleared the company’s Investigational New Drug application (IND) of iadademstat for the FRIDA trial.

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Iadademstat is a small oral molecule that selectively hinders the epigenetic enzyme lysine specific demethylase 1 (LSD1) and has a good differentiating effect in hematologic malignancies.

The open-label, multicentre trial will analyse iadademstat in combination with gilteritinib to treat R/R AML FLT3mut+ patients.

Oryzon intends to carry out the trial at ten to 15 US study centres enrolling up to nearly 45 subjects.

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Assessing the safety and tolerability of iadademstat plus gilteritinib for FLT3mut+ R/R AML and establishing the recommended Phase II dose (RP2D) for the combination are the primary objectives of the trial.

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Evaluation of the combination therapy efficacy as measured by the rate of complete remission and complete remission with partial haematological recovery (CR/CRh), duration of responses (DoR) as well as analysing measurable residual disease are included as secondary objectives. 

If the trial is successful, Oryzon and the regulatory agency have agreed to hold talks to explore the best strategy for advancing the combination treatment for AML patients.

In FLT3·mut+ AML preclinical models, iadademstat and gilteritinib combination was found to demonstrate robust synergy.

Oryzon Genomics Clinical Development and Global Medical Affairs senior vice-president Dr Ana Limon said: “Iadademstat, a uniquely potent and selective LSD1 inhibitor, has already shown a safe profile and high and prolonged responses in AML patients in combination with azacitidine.

“Iadademstat’s excellent pharmacologic properties and synergy with Flt3 inhibitors make this study a very solid proposition for the treatment of this relapsed/refractory patient population.”