Ramoplanin Phase II CDAD results

Oscient (OSCI) said its Ramoplanin did not meet the primary endpoint of non-inferior response rate at the test-of-cure visit versus vancomycin in a Phase II trial to treat Clostridium difficile-associated diarrhea (CDAD). In the open-label U.S. study in 87 patients, those given the higher dose of Ramoplanin (400 mg) had a 71% response rate at the test-of-cure visit (7-14 days post therapy), compared with 78% in the vancomycin arm.

OSCI said the results were comparable, but non-inferiority was not statistically demonstrated because the trial was designed and powered based on published data that suggested the vancomycin response rate would be about 95%. Adverse events were similar for both compounds. ...