Cubist Pharmaceuticals Inc presented the first human data on its investigational cephalosporin antibiotic CAB-175 at the 13th European Congress on Clinical Microbiology and Infectious Diseases (ECCMID) being held May 10 through May 13, 2003 in Glasgow, Scotland.
Results of a Phase 1 study, conducted in the United Kingdom, designed to assess the safety, tolerability and pharmacokinetic (PK) profile of a single intravenous dose of CAB-175 at dose levels of 250 mg, 500 mg and 1000 mg in healthy male subjects were presented. Overall results of the study indicated that a single dose of CAB-175 up to 1000 mg was tolerated by normal, healthy male subjects, and that initial safety and PK results from this study suggest that further clinical evaluation of CAB-175 is warranted. In the study, there were no serious adverse events reported and no subjects discontinued due to an adverse event. The PK results from the study suggested that twice-daily intravenous dosing of the compound may be appropriate in further human clinical studies.
In an oral session, Cubist for the first time presented an overview of completed animal studies on CAB-175. The data presented demonstrated therapeutic efficacy of CAB-175 in a model of pulmonary infection caused by Streptococcus pneumoniae, and against methicillin-resistant Staphylococcus aureus (MRSA) infection in both fibrin clot and thigh tissue models meant to simulate endocardial vegetations (endocarditis) and deep-seated skin and skin structure infections, respectively.
In addition to the human and animal data, multiple posters were presented detailing the microbiologic profile of CAB-175. Most notably, data presented indicate that CAB-175 displays potent bactericidal in vitro activity against MRSA, as well as broad-spectrum bactericidal activity against clinically important Gram-negative and Gram-positive bacteria.