Trius Therapeutics (TSRX) Reports Encouraging Data for TR701-112 in Cellulitis Patients
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Trius Therapeutics, Inc. (Nasdaq: TSRX) reports results of a subgroup analysis from its first Phase 3 investigational study (TR701-112 Trial) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in London. 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 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, showed 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 (EMA) 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%).
Surprisingly, despite the higher overall efficacies seen in the European cellulitis patient population this group had a median lesion area at baseline over double that of their U.S. counterparts – 394 cm² versus 179 cm². Within this population, the tedizolid treated patients had a median lesion area that was 95 cm² larger at baseline than the linezolid treated patients (442 cm² versus 347 cm²). Tedizolid and linezolid treated patients in the U.S. cellulitis population had median lesion areas of 189 cm² and 169 cm² respectively.
The pivotal Phase 3 trial 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, showed 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 (EMA) 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%).
Surprisingly, despite the higher overall efficacies seen in the European cellulitis patient population this group had a median lesion area at baseline over double that of their U.S. counterparts – 394 cm² versus 179 cm². Within this population, the tedizolid treated patients had a median lesion area that was 95 cm² larger at baseline than the linezolid treated patients (442 cm² versus 347 cm²). Tedizolid and linezolid treated patients in the U.S. cellulitis population had median lesion areas of 189 cm² and 169 cm² respectively.
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