The randomized, double-blind, global studies will compare CB-315 (250 mg BID) with the active comparator oral vancomycin (125 mg QID).
Each study is likely to enroll 608 eligible patients.
The studies are intended to assess the difference in clinical response rates at the end-of-therapy (EOT) in patients treated with CB-315 versus oral vancomycina and also the safety of CB-315 in subjects with CDAD.
Cubist chief scientific officer Steve Gilman said that the rates and severity of CDAD are increasing due in part to the spread of a new strain of C. difficile with increased virulence.
”We are very excited to be able to advance CB-315 as a potential therapy, and today’s announcement marks an important milestone as we continue to build a portfolio of potential new therapies for acutely ill patients," Steve added.