Lexington, Massachusetts-based biotech company Curis has received clearance from the FDA to resume a clinical trial that was placed on hold for over a year. The trial is testing the drug emavusertib, which is designed to block the enzyme IRAK4, involved in certain cancers and inflammatory diseases. The trial was put on hold after a participant developed rhabdomyolysis, a known complication of the drug. However, the FDA has now allowed Curis to resume enrolling new patients and has given permission to test higher doses of the drug.
In the trial, emavusertib was given as a monotherapy to 84 patients at doses ranging from 200 mg to 500 mg twice daily. Curis reported significant reductions in abnormal white blood cell counts, known as blasts, in all patient groups. Among patients treated with the 300 mg dose twice daily, two out of three patients with an FLT3 mutation achieved complete response, as did two out of three patients with a spliceosome mutation.
With the FDA’s clearance, Curis has selected the 300 mg dose twice daily for Phase 2 testing of emavusertib as a monotherapy in patients with acute myelogenous leukemia or myelodysplastic syndromes. The trial will enroll patients with an FLT3 or spliceosome mutation who have received multiple prior lines of treatment. In addition, Curis plans to test the drug in combination with azacitidine and venetoclax as a front-line therapy.
Curis President and CEO James Dentzer believes that emavusertib has the potential to be a cornerstone treatment for hematological malignancies. The company reported a cash position of $31.7 million at the end of the first quarter and has reached an agreement to sell stock to existing investors in order to support its clinical trial plans. Updated data from the monotherapy study are expected in 2024, while initial data from the combination study are expected next year.
