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FDA Clears Oryzon's IND for Phase Ib Trial of Iadademstat in FLT3-Mutant AML

NEW YORK – Oryzon on Monday said it has gotten the US Food and Drug Administration's permission to begin a Phase Ib trial of iadademstat plus Astellas' Xospata (gilteritinib) in patients with relapsed or refractory acute myeloid leukemia (AML) harboring an FLT3 mutation.

In the trial, called FRIDA, Oryzon will enroll about 45 patients, evaluate the safety and tolerability of the combination, and establish the recommended Phase II dose. Researchers will also measure patients' rates of complete remission and complete remission with partial hematological recovery on treatment, duration of response, and measurable residual disease.

Iadademstat inhibits LSD1, which has been associated with cancer cell stemness and with more aggressive disease. Xospata is an FLT3 inhibitor, and iadademstat has shown in earlier studies to work synergistically with drugs in this class.

In one study, when iadademstat was given with azacitidine, a chemotherapy that has efficacy in FLT3-mutated AML, to elderly or unfit patients, 78 percent of evaluable patients responded to the combination. Most of these patients achieved a complete remission or complete remission with incomplete count recovery on treatment.

"Epigenetics is emerging as one of the underlying roots of leukemia and other cancers. LSD1 is a key target in this space," Ana Limon, senior VP of clinical development and global medical affairs at Oryzon, said in a statement. "Iadademstat's excellent pharmacologic properties and synergy with FLT3 inhibitors make this study a very solid proposition for the treatment of this relapsed or refractory patient population."

Madrid-based Oryzon is also planning to explore iadademstat as a first-line treatment with immune checkpoint inhibitors for small-cell lung cancer and in a basket study for neuroendocrine tumors.