Trius Therapeutics Announces Data Presentations on Tedizolid at 52nd Annual ICAAC Meeting

Includes Results of ESTABLISH 1, the First Phase 3 Study, and Late-Breaker Exploring Monoamine Oxidase Activity

Online PR News – 13-September-2012 – SAN FRANCISCO – SAN FRANCISCO, Sept. 13, 2012 (GLOBE NEWSWIRE) -- ICAAC 2012 -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections, announced today that several abstracts related to tedizolid phosphate (TR-701) are being presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in San Francisco from September 9 to September 12, 2012. A total of 12 tedizolid-related posters have been accepted for presentation, including clinical results and preclinical studies of tedizolid against gram-positive bacterial infections.

The clinical abstracts examine the effect of tedizolid in patients with acute bacterial skin and skin structure infections (ABSSSI), as well as liver- and renal-impaired, adolescent and elderly populations. The abstracts include two poster presentations from the ESTABLISH 1 trial summarizing detailed results from Trius' first Phase 3 trial (TR-701-112) of tedizolid in patients with ABSSSI. This marks the first time these data are being presented at a major medical meeting. Top-line results, reported in December 2011, showed that tedizolid achieved all primary and secondary efficacy outcomes after a short course of therapy, and showed significant improvements in key safety and tolerability measurements in the complete study population versus the comparator linezolid (Zyvox®). This is the first of two registrational studies for tedizolid.

Tedizolid is the company's lead product candidate. It is a once daily, IV and orally administered oxazolidinone being developed for the treatment of serious gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

"These data add to the growing body of evidence supporting the efficacy and safety of a six-day course of once-daily oral tedizolid," said Jeff Stein, President and Chief Executive Officer at Trius Therapeutics. "We look forward to results from our second Phase 3 study of tedizolid in ABSSSI for its intravenous to oral transition therapy. These findings may offer insights into tedizolid's benefits as a patient's treatment course shifts from hospitalization to post-discharge."

New Data Presented in Late-Breaker Poster
Trius also is presenting early-stage tedizolid data (A-1295a) in the late-breaking poster session. Two randomized, double-blind, placebo-controlled, Phase 1 crossover studies (Study TR701-114 and Study TR701-105) as well as an animal study (5-HTP Mouse Head Twitch Study) demonstrated that tedizolid does not appear to interact with monoamine oxidase (MAO) type A (MAO-A). Published studies have shown that MAO inhibition may be associated with food and drug interactions that affect blood pressure and the body's ability to regulate activity for common neurotransmitters, such as serotonin, norepinephrine and dopamine. In some cases, these interactions can be severe and life-threatening, as for serotonin syndrome.Antibiotic agents with MAO inhibiting activity such as Zyvox are contraindicated in the presence of antidepressants, Parkinson and vasopressive medicines. Tedizolid studies presented at ICAAC have shown that tedizolid treatment does not produce the hallmark signs of interaction with monoamine oxidase, and is therefore not expected to interact with these medications.

About Trius Therapeutics

Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections. The Company's lead investigational drug, tedizolid phosphate, is a once daily, IV and orally administered oxazolidinone in Phase 3 clinical development for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Trius has partnered with Bayer HealthCare for the development and commercialization of tedizolid in Asia and Emerging Markets. In addition to the company's tedizolid clinical program, Trius has initiated IND-enabling studies for its Gyrase-B/ParE development candidate. This dual-inhibitor agent has 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

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