Trius Therapeutics, Inc. (TSRX)

[ariadndndough]

4:34PM Trius Therapeutics announces publication of Tedizolid ESTABLISH 1 Trial in JAMA; Tedizolid achieves All FDA and EMA endpoints in first Phase 3 trial conducted under new draft guidance for acute bacterial skin and skin structure infections (TSRX) 5.37 +0.07 : The ESTABLISH 1 trial examined the efficacy and safety of a 200 mg tablet of tedizolid given once a day for six days versus a 600 mg tablet of linezolid given twice a day for 10 days in 667 patients in North America, Latin America and Europe. The trial was the first pivotal study conducted to prospectively measure the new FDA "early response" primary endpoint of cessation of lesion spread and absence of fever 48-72 hours after the first dose.

As detailed in the JAMA article, tedizolid achieved the primary and all secondary endpoints in the ESTABLISH 1 trial. Approximately 42 percent of pathogens isolated at baseline in the study were methicillin resistant Staphylococcus aureus (MRSA). For both tedizolid and linezolid there was good concordance (>80%) between the early primary endpoint and late investigator assessed secondary endpoints suggesting that the early response is a good indicator of a sustained clinical response to therapy. In addition, the trial showed that tedizolid had a statistically lower impact on platelets.

In December 2012, Trius announced that it completed enrollment of its second ABSSSI trial, ESTABLISH 2. This second pivotal Phase 3 trial was designed to evaluate the efficacy and safety of tedizolid and linezolid when initially administered as an intravenous (IV) infusion with the option to switch to oral therapy. Trius expects to report top-line results from the ESTABLISH 2 study around the end of the first quarter of this year.