Cubist Pharmaceuticals, Inc. has commenced a multi-dose Phase 1 trial in the U.S. for its investigational antibiotic CAB-175 following the filing of an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA).
CAB-175 is a novel parenteral cephalosporin antibiotic that has demonstrated in vitro activity against most clinically relevant Gram-positive and Gram-negative bacteria, including clinically important resistant species. If successfully developed, CAB-175 could be one of the first cephalosporin antibiotics with activity against methicillin-resistant Staphylococcus aureus (MRSA) strains, which are estimated to be the cause of more than 40 per cent of hospital-acquired S. aureus infections in the U.S. and up to 42 per cent and 70 per cent of similar infections in parts of Europe and Asia, respectively.
Cubist expects to investigate CAB-175 as a treatment for a variety of clinical indications, should the Phase 1 studies be successfully completed. Preliminary supportive Phase 1 studies are designed to characterize the safety and pharmacokinetic (PK) profiles of CAB-175 in anticipation of Phase 2 studies.
Michael W. Bonney, president & CEO of Cubist commented: "With the anticipated launch of our lead investigational antibiotic Cidecin (daptomycin for injection) later this year, pending FDA approval, we recognize the need to fill out our product pipeline. CAB-175 fits this need nicely and, if successfully developed, should complement Cidecin and allow us to leverage our commercial infrastructure. Throughout the development of the compound," Mr. Bonney continued, "we are looking forward to working closely with the FDA and participating in its pilot target package insert program called TPI." The TPI (Targeted Product Information) program has been launched by the FDA, in conjunction with the Pharmaceutical Research Manufacturers Association (PhRMA), to guide the design, conduct, and analysis of clinical trials, to facilitate communication between the FDA and pharmaceutical companies, and to promote a shared understanding of a sponsor's drug development program.