New Data Presented at ECCMID Conference Show Short Course of Tedizolid Treatment Highly Effective in Patients with Large Cellulitis Lesions.
Online PR News – 06-April-2012 – San Diego.CA – San Diego, CA, April 2, 2012 – Trius Therapeutics, Inc. (Nasdaq: TSRX) announced today the 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 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 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.
"Although not unexpected, we are pleased to see that patients with severe cellulitis respond very well to a short course of treatment with tedizolid phosphate,” said Philippe Prokocimer MD, Chief Medical Officer of Trius Therapeutics. "The significantly larger lesion area in the European versus U.S. patient populations was unexpected and we look forward to the results of our ongoing 113 trial, which will enroll a higher proportion of European patients than the 112 trial, to determine whether the observed trends continue."
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections. The Company’s lead investigational drug, tedizolid phosphate, is a once daily, IV and orally administered second generation oxazolidinone in Phase 3 clinical development for the treatment of ABSSSI. Trius has two Special Protocol Assessments with the FDA for its two Phase 3 ABSSSI trials and has partnered with Bayer HealthCare for the development and commercialization of tedizolid phosphate outside of the U.S., Canada and the European Union. In addition to the Company’s tedizolid phosphate clinical program, Trius has initiated IND-enabling studies for its Gyrase-B development candidate with potent activity against Gram-negative bacterial pathogens including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. The Gyrase-B program is one of the three preclinical programs supported by federal contracts. For more information, visit www.triusrx.com.
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