Trius Therapeutics Inc. (TSRX) reported the results of a subgroup analysis from its first Phase 3 investigational study in Acute Bacterial Skin and Skin Structure Infections or ABSSSI at the European Congress of Clinical Microbiology and Infectious Diseases meeting in London. The data demonstrated that patients with severe cellulitis showed higher clinical response rates following 6 days of treatment with a single 200 milligram daily dose of oral tedizolid phosphate than those treated for 10 days with two 600 milligram daily doses of oral linezolid.
The pivotal Phase 3 study examined the efficacy and safety of tedizolid phosphate versus linezolid in 667 patients with ABSSSI recruited across sites in North America, South America and Europe. Top-line results, reported in December 2011, demonstrated that tedizolid achieved all primary and secondary efficacy outcomes as well as showed significant improvements in key safety and tolerability measurements in the complete study population.
The cellulitis subgroup analysis of the 112 study compared the relative efficacies of tedizolid and linezolid in the European and U.S. patient populations with severe cellulitis with respect to the primary endpoints established by the European or EMA and U.S. regulatory authorities.
by RTT Staff Writer
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