Cubist Pharmaceuticals Inc. announced the initiation of its pivotal Phase 3 studies evaluating the efficacy and safety of CB-315 in patients with Clostridium difficile-associated diarrhea, or CDAD, with enrollment of a patient in the first of two planned identical global trials. These are randomized, double-blind, global studies in which CB-315 (250 mg BID) is being compared with the active comparator oral vancomycin (125 mg QID). Each trial is expected to enroll 608 eligible patients.
These studies are designed to evaluate the difference in clinical response rates at the end-of-therapy (EOT) in patients treated with CB-315 versus oral vancomycin, as well as the safety of CB-315 in subjects with CDAD. In addition, these studies will evaluate sustained clinical response after treatment.
Cubist’s Chief Scientific Officer Steve Gilman, PhD, said, “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 [this] announcement marks an important milestone as we continue to build a portfolio of potential new therapies for acutely ill patients.”
Date: July 12, 2012
Source: Cubist Pharmaceuticals Inc.
Filed Under: Drug Discovery
