ARTICLE | Clinical News

CB-183: Phase II data

June 20, 2011 7:00 AM UTC

Top-line data from the modified intent-to-treat (mITT) population (n=199) of a double-blind, U.S. and Canadian Phase II trial in 209 patients showed that twice-daily 125 and 250 mg oral CB-183,315 for 10 days led to comparable clinical cure rates defined as resolution of diarrhea at day 12, the primary endpoint, to that of 125 mg oral Vancocin vancomycin given 4 times daily for 10 days (92% and 87%, respectively, vs. 89%). Cubist said the trial was not powered to assess the statistical significance of non-inferiority to Vancocin. Additionally, high-dose CB-183,315 had a significantly lower recurrence rate vs. Vancocin (17% vs. 36%, p=0.035), but low-dose CB-183,315 did not (28%). ...