Cubist Pharmaceuticals Announced CB-315 Phase 3 Trial of Diarrhea

Cubist Pharmaceuticals, Inc. introduced the initiation of the pivotal Phase 3 studies understanding the efficacy and overall safety of CB-315 in affected individuals along with Clostridium difficile-associated diarrhea, or CDAD, along with enrollment of an affected person to begin with of two plotted out identical global tests. These are generally randomized, double-blind, global studies wherein CB-315 (250 mg BID) is being compared with the active comparator oral vancomycin (125 mg QID). Each trial is predicted to actually enroll 608 eligible affected individuals.

Each of these studies are created to evaluate the distinction in clinical response rates for the end-of-therapy (EOT) in patients handled along with CB-315 versus oral vancomycin, in addition to safety of CB-315 in subjects with CDAD. Additionally, these research studies will evaluate maintained clinical result after therapy.

Cubist's Chief Scientific Officer Steve Gilman, PhD, said: "The rates and intensity of CDAD are increasing due partly to the spread of a new strain of C. difficile with higher virulence. We happen to be incredibly pretty excited to have the ability to improve CB-315 as a possible therapy, and current announcement fingerprints an important goal as we always build a portfolio of possible new therapies for severely sick affected individuals."