Trius Announces Positive Results From ESTABLISH 2 Study of Tedizolid in Severe Skin Infections

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

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

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).

"The consistently strong results of the two Phase 3 studies support the
promise of tedizolid as a safe and effective new antibiotic, especially in an
era of increasing multi-drug resistant Staphylococcus aureus," said Andrew F.
Shorr, M.D. MPH, Associate Professor of Medicine, Washington Hospital Center,
Washington, D.C. "The potential to treat severe MRSA infections with a novel
once-daily agent and a shorter course of therapy offers substantial benefits
to patients and, potentially, payers and the healthcare system."

"These results confirm Trius' ability to successfully execute a comprehensive
clinical program intended to support global approval," said Jeffrey Stein,
Ph.D., President and Chief Executive Officer of Trius. "We are committed to
responding to the needs of patients and physicians worldwide for new and
effective antibiotics. Looking ahead, we intend to file our NDA for tedizolid
as well as initiate a Phase 3 study of tedizolid in patients with severe
pneumonia during the second half of this year."

Data from the ESTABLISH 1 study, which tested the oral dosing of tedizolid,
were published in The Journal of the American Medical Association (JAMA) in
February 2013. "The collective results of ESTABLISH 1, ESTABLISH 2 and
additional clinical studies support the differentiated profile of tedizolid
and pave the way for new drug application (NDA) and marketing authorization
application (MAA) submissions in the U.S. and European Union, respectively,"
added Dr. Philippe Prokocimer, Chief Medical Officer of Trius.

Scheduled Conference Call

The Company will host a conference call to discuss the results today, March
25, 2013, at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time). The conference
call may be accessed by calling (877) 303-9219 for domestic callers and (760)
666-3559 for international callers. Please specify to the operator that you
would like to join the "Trius Therapeutics Conference Call." The conference
call will also be webcast live under the Investors section of the Trius
website at http://investor.triusrx.com, where it will be archived for 30 days
following the call.

About Trius Therapeutics

Trius Therapeutics, Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of innovative antibiotics for
serious infections. The Company's lead investigational drug, tedizolid
phosphate, is a novel antibiotic 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. 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 promise of tedizolid
phosphate as a safe and effective new antibiotic, physicians' acceptance of
tedizolid phosphate, the expected timing of initiation of a Phase 3 study of
tedizolid phosphate in patients with severe pneumonia, and matters regarding
NDA and MAA regulatory submissions. 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; the outcome of final analyses of data
from recently-completed clinical trials of tedizolid phosphate may vary from
Trius' initial analyses and the FDA may not agree with Trius' interpretation
of such results; additional ongoing or planned clinical trials of tedizolid
phosphate may produce negative or inconclusive results; Trius may decide, or
the FDA may require Trius, to conduct additional clinical trials or to modify
Trius' ongoing clinical trials; Trius may experience delays in the
commencement, enrollment, completion or analysis of clinical testing for its
product candidates, or significant issues regarding the adequacy of its
clinical trial designs or the execution of its clinical trials, which could
result in increased costs and delays, or limit Trius' ability to obtain
regulatory approval; the third parties with whom Trius has partnered with for
the development of tedizolid phosphate and upon whom Trius relies to conduct
its clinical trials and manufacture its product candidates may not perform as
expected; tedizolid phosphate may not receive regulatory approval or be
successfully commercialized; unexpected adverse side effects or inadequate
therapeutic efficacy of tedizolid phosphate could delay or prevent regulatory
approval or commercialization; 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 recent 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
 
Press spacebar to pause and continue. Press esc to stop.