NEW YORK – Ellipses Pharma said on Wednesday the US Food and Drug Administration cleared its investigational new drug application for the dual FLT3 and Aurora kinase inhibitor, EP0042, in acute myeloid leukemia.
The IND clearance allows London-based Ellipses to expand its ongoing Phase I/II clinical trial of EP0042 to include US patients. The study will enroll a total of 63 AML patients, including 20 patients with FLT3 internal tandem duplication-mutant AML and 10 patients with FLT3 wild-type AML.
The trial is enrolling pretreated patients who have relapsed on initial treatment and have had no more than three prior lines of therapy, including FLT3 inhibitors, induction chemotherapy, hypomethylating agents, and allogeneic stem cell transplant. Ellipses is developing EP0042 to combat acquired resistance to FLT3 inhibitors in patients with AML.
Once the recommended Phase II dose has been identified, Ellipses will evaluate EP0042 as both a monotherapy and in combination with standard treatments in the study.
"This FDA approval of EP0042's investigational new drug application allows us to open additional trial sites in the world's foremost pharmaceutical market," Ellipses CEO Rajan Jethwa said in a statement. "This will help us in achieving our strategic goal of bringing potential new treatment options to patients in need at unprecedented speed, whilst also allowing us to engage with key industry and academic partners."
In December, Ellipses presented preliminary data from the Phase I/II trial of EP0042 in 23 evaluable relapsed or refractory AML patients. Across all dose levels, 13 patients achieved stable disease as the best response.