Cubist said that this Phase I trial is the first time CB-182,804 has been given to humans and is designed to evaluate the safety and pharmacokinetics of CB-182,804 in normal human subjects.
According to the company, preclinical studies of CB-182,804 demonstrated safety and efficacy in animal models with important Gram-negative pathogens such as Escherichia coli, Acinetobacter, Pseudomonas and Klebsiella. The investigational new drug application for CB-182,804 was submitted to the FDA in December 2008.
If the results of the Phase I safety trials are positive, Cubist plans to conduct Phase II studies to examine the safety and efficacy of CB-182,804 in patients with Gram-negative infections.
Steve Gilman, senior vice president and chief scientific officer of Cubist, said: Gram-negative infections represent a very significant unmet medical need with few effective therapies available, so we are happy to be working toward providing a potential new treatment option for patients in need.
Cubist Pharmaceuticals is a biopharmaceutical company, which focused on the research, development, and commercialization of pharmaceutical products. The Cubist product pipeline includes ecallantide, a recombinant human protein in Phase 2 clinical trials — CONSERV-1 and CONSERV-2 — for the prevention of blood loss during cardiothoracic surgery and two Phase 1 programs that addresses unmet medical needs in CDAD (Clostridium difficile-associated diarrhea) and multi-drug resistant (MDR) Gram-negative infections. In addition, the Company, in collaboration with Alnylam (Cambridge, MA), has pre-IND and a Phase 2 program underway in novel treatments for respiratory syncytial virus infections using Alnylam’s RNA-interference technology. The company also has internal pre-IND research programs underway targeting novel antibacterials and Hepatitis C infections.