Trius Therapeutics Inc' Antibiotic Tedizolid Demonstrates High Efficacy In Patients With Cellulitis

Trius Therapeutics Inc announced results of a subgroup analysis from its first Phase 3 investigational study (TR701-112 Trial) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The data demonstrated that patients with severe cellulitis displayed 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 trial examined efficacy and safety of tedizolid phosphate versus linezolid in 667 patients with ABSSSI recruited across sites in North America, South America and Europe. 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 and U.S. (FDA) regulatory authorities. The results showed that European patients treated with tedizolid phosphate showed a higher clinical response rate (98% versus 91%) than those treated with linezolid with respect to the EMA primary endpoint. The European patients treated with tedizolid also showed a higher response rate than the linezolid treated patients (82% versus 76%) with respect to the FDA primary endpoint. The higher tedizolid efficacy in cellulitis was also seen in the U.S. patient population on the EMA endpoint (82% versus 78%) as well as the FDA endpoint (72% versus 69%).