The US Food and Drug Administration has approved an Investigational New Drug application for EP0042, a dual FLT-3 and aurora kinase inhibitor. The therapy is being developed as a new potential treatment to overcome acquired resistance to FLT3 inhibitors in patients with acute myeloid leukemia (AML).
This approval will allow Ellipses, the manufacturer of the drug, to expand its ongoing first in-human phase I/II clinical trial, which is currently undergoing its dose-ranging phase. Once a recommended phase II dose is confirmed, Ellipses will continue to evaluate EP0042 as a monotherapy and explore EP0042 in combination with established standard treatments.
Preliminary data shared from this ongoing study at the 2022 American Society of Hematology Annual Meeting and Exposition showed EP0042 had acceptable safety and tolerability with evidence of prolonged disease control in a number of heavily pretreated patients with AML.
Source: Ellipses, February 2023