Curis, Inc., a biotechnology company focused on the development of emavusertib, an orally available small molecule triple target inhibitor (IRAK4, FLT3 and CLK) for the treatment of hematologic malignancies, announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. The recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been established at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS).
In addition to removing the clinical hold, Curis plans to enroll targeted patients with AML who have specific mutations and have received limited prior treatments. They also plan to initiate a front-line combination study of emavusertib with other drugs. James Dentzer, President and CEO
The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on Curis' TakeAim Leukemia Phase 1/2