ELLIPSES PHARMA PUBLISHES DATA FROM ONGOING PHASE 1/2 CLINICAL TRIAL OF EP0042
London, UK, 9th December 2024: Ellipses Pharma Limited (“Ellipses”), a global drug development company focused on accelerating the development of new oncology treatments, has published the latest data from an ongoing Phase 1/2 clinical trial of EP0042, an orally available novel agent that targets the Aurora kinase axis, in patients with acute myeloid leukaemia (AML).
The data was presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, in San Diego, California via poster 1500: EP0042, a dual FLT3 and Aurora kinase inhibitor: final results of dose escalation and optimization cohorts from a phase 1/2a study in patients with R/R AML, CMML or MDS.
The presentation included final data from the dose finding and optimisation cohorts and preliminary data for the combination of EP0042 + venetoclax. The data builds on the encouraging data previously reported from the trial, confirming that EP0042 monotherapy has a manageable safety profile with encouraging evidence of activity in heavily pretreated patients with R/R AML.
Preliminary data from an ongoing cohort of patients receiving EP0042 + venetoclax indicate that the combination has a manageable safety profile and promising initial evidence of activity in patients with R/R AML +/- TP53 mutations with/without prior treatment with venetoclax.
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for EP0042.
The ongoing clinical study on EP0042 follows earlier drug discovery and development work led by The Institute of Cancer Research, London.
Professor Tobi Arkenau, Head of Global Drug Development & Chief Medical Officer at Ellipses Pharma, commented: “We are very encouraged by these data that build further evidence for the promise of EP0042 in AML and we are continuing to evaluate the potential of this novel agent in combination with standard of care therapy.”
Professor Sir Christopher Evans, Executive Chairman of Ellipses Pharma, said:
“We have been heartened by the continuing progress we are making with the development of EP0042 which continues to show considerable promise as a potential treatment for AML – an area of huge unmet need.”
