CXA-101: Phase II data

Data from the mMITT population (n=103) of a double-blind, active-controlled, international Phase II trial showed that IV CXA-101 every 8 hours for 7-10 days led to a microbiologic cure rate of 83% at the TOC visit 6-9 days after the end of therapy vs. 76% for IV ceftazidime every 8 hours. In the ME population (n=82), CXA-101 led to a microbiologic cure rate of 86% at the TOC visit vs. 93% for ceftazidime. Eradication rates of Escherichia coli were 92% and 95% in the CXA-101 and ceftazidime groups, respectively. Both treatments were well tolerated.

Patients in the mMITT population required isolation of 1 or 2 pathogens at >=105 CFU/mL from a baseline urine culture, while the ME population required a urine culture obtained at the TOC visit and adherence to the trial protocol. Data were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Boston. Cubist previously reported data from about 120 patients showing that CXA-101 demonstrated "favorable microbiological and clinical outcomes" at the TOC visit, the primary and secondary endpoints, vs. ceftazidime (see BioCentury, July 5). ...