Escend Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the Investigational New Drug (IND) application to begin the Phase I study of its lead drug candidate, ES-3000.

The orally bioavailable small molecule, ES-3000 ablates leukemic stem cells by reducing β-catenin expression using a new mechanism of action.

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Wnt/β-catenin is a critical cancer stem cell survival pathway.

The Phase I clinical trial has been designed to evaluate the tolerability and safety of ES-3000 in relapsed or refractory (R/R) acute myeloid leukemia (AML) people.

Escend Pharmaceuticals co-founder and CEO Saira Bates said: “The IND clearance strengthens our deep commitment to the development of ES-3000, which can potentially offer a new treatment option for durable remissions and reduce relapse by targeting leukemic stem cells, which play a central role in resistance to therapy.”

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AML is the most common acute leukemia in adults and is an aggressive cancer of the blood and bone marrow that prevents white blood cells from maturing and results in an accumulation of blasts.

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Each year approximately 20,000 people in the US are diagnosed with the disease.

Previously, ES-3000 received orphan designation from the FDA Office of Orphan Products Development to treat AML and chronic myeloid leukemia (CML).

The company stated that the drug candidate is being developed to treat myelodysplastic syndrome (MDS) and triple negative breast cancer (TNBC).  

Escend Pharmaceuticals co-founder and chairman Dennis Brown said: “We are very excited to be able to initiate our US study. ES-3000 is a novel small molecule with promising pre-clinical data that supports targeting leukemic stem cells.”