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Trius Therapeutics, Inc. (TSRX) Message Board

  • beavertail_splash beavertail_splash Apr 4, 2013 9:01 PM Flag

    PRESENTATION HIGHLIGHTS

    SUMMARY: All primary and secondary efficacy endpoints were met for FDA and EMA
    • Safety profile indicated that tedizolid was safe and well tolerated
    • Results are consistent with those from ESTABLISH 1 and support filings for
    global regulatory approval
    • Combined results of all clinical studies support tedizolid differentiation:
    – Safe, well tolerated, fast acting drug for resistant gram positive infections
    – Convenient once daily IV or oral administration over short course of therapy
    – Fewer drug-drug interactions
    – Active against key linezolid resistant strains
    Next Steps: Tedizolid 9 month toxicity data support indications
    requiring long term dosing
    The problem: Dosing linezolid longer than 28 days has been associated with
    incidents of peripheral and optic neuropathies. In some cases this has been
    irreversible. Accordingly, linezolid is not indicated for bacteremia or other infections
    requiring longer term dosing.
    3 & 6 month toxicity data support Tedizolid indications
    requiring long term dosing
    No sciatic nerve degeneration
    No functional nerve anomalies
    No sciatic nerve degeneration
    No functional nerve anomalies
    Next Steps: Tedizolid 9 month toxicity data support indications
    requiring long term dosingData expected for Q2 2013
    Rat Model of Peripheral and Optic Neuropathy: Tedizolid & Linezolid* results
    Tedizolid (6x clinical exposure)
    Linezolid (1x clinical exposure)

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