This Day On The Street
Continue to site
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

Trius Announces Publication Of Tedizolid ESTABLISH 1 Trial In JAMA

SAN DIEGO, Feb. 12, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery and development of innovative antibiotics for serious infections, announced today that the results from ESTABLISH 1, a Phase 3 study of tedizolid phosphate (TR-701) versus linezolid (Zyvox®) completed in 2011, have been published in The Journal of the American Medical Association (JAMA).

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. The trial also measured as secondary endpoints this "early response" sustained to the end of therapy (EOT; day 11) as well as captured the EMA endpoint of clinical investigator's assessment at the post-treatment evaluation visit (7-14 days after EOT).

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 and was associated with a statistically significant lower rate of gastrointestinal (GI) adverse events than linezolid.

"While being the pioneer on a pivotal study conducted under new guidance offers many challenges, the results speak for themselves and are a testimony to the extraordinary efforts of the Trius team working in concert with the FDA," said Philippe Prokocimer, M.D., Chief Medical Officer at Trius and lead author of the JAMA article. "Publication of the ESTABLISH 1 trial results in JAMA further confirms the need for new antibiotics such as tedizolid."

In an accompanying editorial in the JAMA issue, Drs. Shira Doron and Helen Boucher state, "Much can be learned from the current study about the appropriate use of antibiotics for the treatment of these common infections, and the design of future trials for treatment of ABSSSI." They also highlight that "Tedizolid is a new oral antibiotic that appears efficacious using a short course of therapy and may have a better safety profile than linezolid."

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.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%
YHOO $36.60 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs