SAN DIEGO, April 23, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) announced today that the results of a large, late-stage human study, called ESTABLISH 2, and multiple other clinical studies from its experimental antibiotic, tedizolid phosphate (TR-701), will be presented in poster and oral presentations at the European Congress of Clinical Microbiology and Infectious Diseases ( ECCMID) meeting in Berlin from April 27-30. A total of three tedizolid-related posters and one oral presentation have been accepted for presentation, including clinical and safety results.
The clinical abstracts examine the effect of tedizolid in patients with acute bacterial skin and skin structure infections (ABSSSI), as well as cardiac and medication interaction safety trials. The abstracts include a poster presentation from the ESTABLISH 2 trial, the second of two late-stage or Phase 3 studies needed for U.S. and E.U. regulatory filings. As in the ESTABLISH 1 study, which tested the pill form of tedizolid, the ESTABLISH 2 intravenous (IV) to pill transition study captured the endpoints for ABSSSI established by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These presentations mark the first time ESTABLISH 2 data are being presented at a major medical meeting. Top-line results, reported in March 2013, showed that tedizolid achieved all primary and secondary efficacy outcomes after a short course of therapy using one-tenth the amount of total drug versus the comparator linezolid (Zyvox ®). Patients receiving tedizolid also showed numerical improvements in key safety and tolerability measurements in the complete study population.
"The results of ESTABLISH 2 combined with those from ESTABLISH 1 and additional clinical studies support the differentiated profile of tedizolid as a potential new treatment option for patients with severe skin infections," said Dr. Philippe Prokocimer, Chief Medical Officer of Trius.