Trius Therapeutics Reports Data On Broad-Spectrum Antibiotics At 52nd Annual ICAAC Meeting

SAN FRANCISCO, Sept. 12, 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, today announced preclinical studies related to a new class of broad-spectrum, gram-negative antibacterial agents that are directed against novel targets Gyrase B (GyrB) and ParE. Trius scientists and research collaborators are presenting the results at the 52 nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting being held in San Francisco from September 9-12, 2012. Fourteen posters and one podium presentation related to the company's GyrB/ParE preclinical program are being featured, including both in vivo and in vitro studies.

Currently there are no antibiotics in clinical use that inhibit both GyrB and ParE—two microbial enzymes essential for the replication of bacteria. As a result of the crisis of increasing bacterial resistance, there is an urgent need for new antibiotics, especially those active against common clinical infections caused by gram-negative pathogens. However, the development pipeline of gram-negative agents to replace resistant therapies is limited. Treatment of gram-negative bacterial infections can be difficult, because of the pathogen's double cell membrane, efflux pumps and ability to quickly mutate to develop resistance. As of 2011, the Centers for Disease Control and Prevention estimates that roughly 1.7 million hospital-associated infections, from all types of bacteria, cause or contribute to 99,000 deaths each year.

The data abstracts examine the effect of Trius' antibacterial agents against a panel of gram-positive and gram-negative pathogens. The results show significant potency in treating challenging gram-negative bacteria associated with hospital-acquired infections, such as Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumonias, and biodefense pathogens such as Yersinia pestis (plague), Francisella tularensis, Burkholderia mallei and Burkholderia pseudomallei.

As reported in the presentations, Trius' antibacterial agents exhibit bactericidal (bacteria-killing) activity, low minimum inhibitory concentrations (MICs), and reduced emergence of bacterial resistance versus comparators such as ciprofloxacin. The compounds' dual-targeting mechanism may impair bacteria's ability to develop resistance, as suggested by previous studies. 1,2 These dual-inhibitor agents also avoid cross-resistance with established antibiotic classes, including the fluoroquinolones. This is consistent with the fact that the compounds bind to different subunits of DNA gyrase and topoisomerase IV than current antibiotics, such as fluoroquinolones. 

"The preclinical studies demonstrate potent activity against gram-negative pathogens, supporting the continued development of broad-spectrum antibiotics targeting GyrB and ParE," said Jeff Stein, President and Chief Executive Officer at Trius Therapeutics. "Since the discovery of quinolones in the 1960s, we believe this is the first new chemical class of antibiotics with potent activity against a wide range of gram-positive and gram-negative bacteria. The emergence of multi-drug resistant infections underscores the need for unique antibacterial agents. Based on the encouraging results, we look forward to submitting an Investigational New Drug (IND) application and anticipate initiating a Phase 1 trial in 2013."

New In Vivo Poster Presentations

In abstracts containing animal model studies, researchers administered Trius' antibacterial agents intravenously in gram-negative infected mouse models. The compounds demonstrate significant antimicrobial activity against hospital-acquired pathogens versus comparator levoflaxin (F-2028), as well as rapid and extensive tissue distribution to target organs (F-2026). In a biodefense-related study, Colorado State University investigators show that a dual-inhibitor GyrB/ParE agent provides significant long-term protection in a Burkholderia pseudomallei lung infection model (F-2022).

GyrB/ParE program studies were fully funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. In September 2008, Trius entered into a five-year contract with the NIAID, under which the company may receive up to $27.7 million in research grants. 

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 .

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 Trius' ability to meet its future financing needs and successfully complete its ongoing clinical trials and development programs and transition 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.

1 Walsh, C. Antibiotics: Actions, Origins, Resistance, American Society of Microbiology (ASM) Press: Washington, DC, 2003.

2 Silver, L. L. Nat. Rev. Drug Disc. 2007, 6, 31.
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