This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Trius Announces Positive Results From ESTABLISH 2 Study Of Tedizolid In Severe Skin Infections

Tedizolid Met All Primary and Secondary Efficacy Outcomes Designated by the FDA and EMA

NDA Filing Expected Second Half of This Year

SAN DIEGO, March 25, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) today announced top-line results from its ESTABLISH 2 Phase 3 clinical trial of tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA). As in the ESTABLISH 1 study, which tested the oral dosage form of tedizolid, the ESTABLISH 2 intravenous (IV) to oral transition study captured the endpoints for ABSSSI established by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Trius conducted the trial at 95 sites in North and South America, Europe, Australia, New Zealand and South Africa. The randomized, double-blind, placebo-controlled study enrolled 666 patients with ABSSSI. Patients received either 200 mg of tedizolid once a day for six days of treatment plus four days of placebo or 600 mg of linezolid (Zyvox®) twice a day for 10 days of treatment. Patients initially received the IV dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatment.

Tedizolid met its primary endpoint of non-inferiority (10% NI margin) to linezolid as measured by a 20 percent or greater reduction in lesion area at 48 to 72 hours after the first infusion of study drug. Tedizolid also met all secondary efficacy endpoints measured at both the end of therapy and post treatment evaluations.

Clinical Response

         
ITT Analysis Set   Tedizolid 6 days treatment, % (n = 332) Linezolid 10 days treatment, % (n = 334) Treatment Difference (95% CI), %
Primary Endpoint ≥20% decrease from baseline in lesion area at 48-72 hours 85.2 82.6 2.6 (-3.0 to 8.2)
Key Secondary Endpoints Sustained clinical response at end of therapy 87.0 88.0 -1.0 (-6.1 to 4.1)
  Investigators assessment of clinical response at 7-14 days after end of therapy 88.0 87.7 0.3 (-4.8 to 5.3)
Sensitivity analysis (2010 FDA guidance) Cessation of spread and absence of fever at 48-72 hours 85.8 81.4 4.4 (-1.2 to 10.1)

As in the ESTABLISH 1 study, both tedizolid and linezolid were generally well tolerated in ESTABLISH 2 with drug-related treatment emergent adverse events (TEAE) reported in 20.5% of tedizolid patients versus 24.8% of linezolid treated patients. Gastrointestinal adverse events were the most commonly reported of all TEAEs (16.0% in tedizolid vs. 20.5% in linezolid).

1 of 2

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,975.59 +15.02 0.09%
S&P 500 1,979.17 +0.83 0.04%
NASDAQ 4,447.7060 -1.8580 -0.04%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs