Oryzon Genomics - Encouraging interim update on FRIDA

Oryzon Genomics has reported positive interim data from the Phase Ib FRIDA study, evaluating iadademstat in combination with gilteritinib in advanced acute myeloid leukaemia (AML) patients. Results from the first two cohorts (13 patients) showed a favourable safety profile and efficacy signals, with 69% of patients reporting bone marrow (BM) blast cell clearance in the first cycle. Moreover, 38% of patients achieved complete remission with full or partial hematologic or blood count recovery. While we caution against direct read across between clinical trials, this compares favourably to the 26.3% rate (excluding remissions after bone marrow transplantation during the trial) delivered by gilteritinib in the Phase III ADMIRAL study, potentially supporting the synergy of the combination. Oryzon noted that the first two cohorts achieved full target engagement and indicated the scope for dose reduction (to aid faster platelet recovery) under the FDA’s OPTIMUS guidance. A third cohort is being recruited following this guidance.