SAN DIEGO, Sept. 15, 2011 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) announced today that the Company has completed the enrollment of the first of two planned Phase 3 trials of tedizolid phosphate (formerly known as torezolid phosphate) in the study of acute bacterial skin and skin structure infections (ABSSSI). The pivotal Phase 3 trial, designated TR701-112, examined the efficacy and safety of a six day course of oral tedizolid phosphate therapy versus 10 days of oral therapy with linezolid (Zyvox®) in 667 patients recruited across sites in North and South America and Europe. Trius plans to start its second Phase 3 trial of tedizolid phosphate in ABSSSI, designated TR701-113, for its intravenous (IV) to oral transition therapy later this year.
"Completing the enrollment of this Phase 3 trial represents another important milestone for Trius as we are the first company to conduct such a pivotal trial under the new FDA guidance for ABSSSI," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Trius. "The completion of the trial is a testament to our team's ability to execute on a challenging new protocol and will allow us to report results in early 2012."
About Trius Therapeutics
Trius Therapeutics 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 an IV and orally administered second generation oxazolidinone in Phase 3 clinical development for the treatment of ABSSSI. Trius has two Special Protocol Assessments (SPA) with the FDA for its two Phase 3 ABSSSI trials and has partnered with Bayer HealthCare for the development and commercialization of tedizolid phosphate outside of the U.S. and the European Union. In addition to the company's tedizolid phosphate clinical program, Trius is currently conducting three preclinical programs using its proprietary discovery platform to develop antibiotics to treat infections caused by gram-negative bacteria. 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 commencement of Trius' second Phase 3 study of tedizolid phosphate. Risks that contribute to the uncertain nature of the forward-looking statements include: Trius' ability to obtain additional financing; the success and timing of Trius' preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; the performance of third-party manufacturers; changes in Trius' plans to develop and commercialize its product candidates; 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 Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, 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.