NEW YORK – Oryzon Genomics said on Wednesday that it has treated the first acute myeloid leukemia patient in its Phase Ib trial of iadademstat plus Astellas' Xospata (gilteritinib).
The firm is evaluating the iadademstat-Xospata combination as a treatment for relapsed or refractory AML patients whose cancers harbor a FLT3 mutation. The trial, dubbed FRIDA, will take place at 10 to 15 sites throughout the US and will include roughly 45 patients.
As a primary objective, Oryzon is evaluating the treatment combination's safety and tolerability and establishing a recommended Phase II dose. As secondary objectives, Oryzon is evaluating the treatment's preliminary efficacy including patients' complete remission and complete remission with partial hematological recovery, their duration of responses, and their measurable residual disease.
If the FRIDA trial is successful, according to Oryzon, the firm has already made plans with the US Food and Drug Administration to meet regarding the next steps to develop iadademstat.
The combination of iadademstat, a small molecule inhibitor of lysine-specific histone demethylase 1, or LSD1, and Xospata has demonstrated synergy in preclinical models of FLT3-mutant AML, according to Barcelona-based Oryzon. Last year, the firm received a non-refundable public grant worth about €1.9 million ($2 million) to develop iadademstat for AML.