Trius Therapeutics Completes Enrollment in Second Phase 3 Trial of Tedizolid for Skin and
Skin Structure Infections
SAN DIEGO, Dec. 10, 2012 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery and development of innovative antibiotics for life-threatening infections, announced today that it has reached its enrollment objective of 658 patients in the last of its two Phase 3 clinical trials of tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The pivotal Phase 3 trial, designated ESTABLISH 2, examines the efficacy and safety of a six-day course of tedizolid
administered once a day versus a 10-day course of linezolid (Zyvox®) administered twice a day in patients recruited across sites in North and South America, Europe, Australia, New Zealand and South Africa. For both tedizolid phosphate and linezolid, drug was initially administered as an intravenous (IV) infusion with the option to switch to oral therapy after the initial day of therapy.
"As with our ESTABLISH 1 study, ESTABLISH 2 was designed to prepare tedizolid for registration globally by capturing both the new and former FDA endpoints as well as the European endpoints for ABSSSI," said Jeffrey Stein, Ph.D., President and Chief Executive Officer at Trius. "We remain on schedule to report top-line results from this study in early 2013. The tedizolid clinical program reflects our commitment to bring safe, well-tolerated and convenient therapies to people with life-threatening infections."
Last year, Trius completed its ESTABLISH 1 study, testing the oral dosing of tedizolid under the same trial design and endpoints as in ESTABLISH 2. The trial achieved all primary and secondary efficacy outcomes and showed significant safety and tolerability improvements versus linezolid.
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 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 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
. The Gyrase-B program is one of the two preclinical programs supported by federal contracts. For more information, visit
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 expected timing of Trius' reporting of top-line results from the Establish 2 study. 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.
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