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news.GlaxoSmithKline (GSK) has commenced two different Phase 2b trials to asssess GSK 2251052 (GSK '052) in patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
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The company expects to recruit around 200 patients in each of the trials.
Earlier in July 2010, GSK has obtained license for this compound from Anacor Pharmaceuticals under a research and development contract.
The Phase 2b trial in cUTI, which will evaluate the safety, efficacy and tolerability of GSK ‘052 in adult patients with febrile lower cUTI and acute pyelonephritis, is a multi-canter, randomized, double-blind and multi-dose study to compare GSK ‘052 with imipenem-cilastatin.
The Phase 2b trial in cIAI is a multi-center, randomized, double-blind, multi-dose study of the safety, tolerability and efficacy of GSK ‘052 in the treatment of cIAI in adults.
In this study, GSK ‘052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI.
In the preclinical and Phase 1 studies the drug demonstrated positive response in the treatment of infections associated with Gram-negative bacteria, including E. coli, K. pneumoniae, Citrobacter spp., S. marcescens, P. vulgaris, Providentia spp., Pseudomonas aeruginosa and Enterobacter spp. as well as other pathogens responsible for both cUTI and cIAI.