After a more than a sevenfold rise in value over the past year, Curis (NASDAQ:CRIS) appears to be on track to record its biggest one-day loss in more than a decade.
Before the market opened today, the company released updated data from its ongoing Phase 1/2 study for CA-4948 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS).
The trial looking to select the recommended Phase 2 dose involved 22 patients (11 with high-risk MDS, 11 with AML) across dose cohorts of 200 mg BID, 300 mg BID, 400 mg BID, and 500 mg BID.
Even though with no dose-limiting toxicities (DLT), the company has selected 300mg BID as the recommended dose, safety concerns have appeared in higher dose levels.
In the 400mg and 500mg cohorts 13% and 66% of patients experienced DLT, respectively, the Curis announced referring to its presentation at European Hematology Association 2021 Virtual Congress (EHA).
In December, the company had only begun enrollment in the 400 mg BID cohort as no DLTs were observed in seven DLT-evaluable patients at lower dose levels.