Trius Announces Publication of Tedizolid ESTABLISH 1 Trial in JAMA

Trius 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Under New Draft Guidance for Acute Bacterial Skin and Skin Structure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 (ABSSSI)

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.

About Trius Therapeutics

Trius Therapeutics, Inc. is a biopharmaceutical company focused on the
discovery and development of innovative antibiotics for serious infections.
The Company's lead investigational drug, tedizolid phosphate, is a once daily,
IV and orally administered second generation oxazolidinone in Phase 3 clinical
development for the treatment of serious gram-positive infections, including
those caused by methicillin-resistant Staphylococcus aureus (MRSA). Trius has
partnered with Bayer HealthCare for the development and commercialization of
tedizolid phosphate outside of the U.S., Canada and the European Union. In
addition to the Company's tedizolid phosphate clinical program, Trius has
initiated Investigational New Drug (IND) enabling studies for its Gyrase-B
development candidate with potent activity against Gram-negative bacterial
pathogens including multi-drug resistant strains of E. coli, Klebsiella,
Acinetobacter and Pseudomonas. The Gyrase-B program is one of the two
preclinical programs supported by federal contracts. For more information,
visit www.triusrx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not
historical facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such statements are
subject to risks and uncertainties, actual results may differ materially from
those expressed or implied by such forward-looking statements. Such statements
include, but are not limited to, statements regarding the following: Trius'
ability to successfully complete its ongoing clinical trials and development
programs; gaining FDA approval for tedizolid; and transitioning into
commercialization. Risks that contribute to the uncertain nature of the
forward-looking statements include: the accuracy of Trius' estimates regarding
expenses, future revenues and capital requirements; the success and timing of
Trius' preclinical studies and clinical trials; regulatory developments in the
United States and foreign countries; changes in Trius' plans to develop and
commercialize its product candidates; Trius' ability to obtain additional
financing; Trius' ability to obtain and maintain intellectual property
protection for its product candidates; and the loss of key scientific or
management personnel. These and other risks and uncertainties are described
more fully in Trius' most recently filed SEC documents, including its Form
10-K, Forms 10-Q and other documents filed with the United States Securities
and Exchange Commission, including those factors discussed under the caption
"Risk Factors" in such filings. All forward-looking statements contained in
this press release speak only as of the date on which they were made. Trius
undertakes no obligation to update such statements to reflect events that
occur or circumstances that exist after the date on which they were made.

CONTACT: Public Relations Contact:
         Laura Kempke/Andrew Law at MSLGROUP
         trius@mslgroup.com
         781-684-0770
        
         Investor Relations Contact:
         Stefan Loren at Westwicke Partners, LLC
         sloren@westwicke.com
         443-213-0507
 
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