SAN DIEGO, Sept. 29, 2011 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) announced today the dosing of the first patient in a second global Phase 3 pivotal trial in acute bacterial skin and skin structure infections (ABSSSI). The trial, designated TR701-113, is testing tedizolid phosphate (formerly known as torezolid phosphate) administered initially as a once-daily intravenous (IV) infusion with the possibility to switch to once-daily oral therapy in ABSSSI patients. The 113 study is the first clinical trial conducted in collaboration with Bayer HealthCare and, as a result, will recruit patients in North and South America, Europe, South Africa and Asia. The dosing of the first patient in the 113 study triggers a milestone payment to Trius under its collaboration agreement with Bayer.
The 113 study and the recently enrolled TR701-112 study are designed to compare the efficacy and safety of once-daily administration of 200 milligrams of tedizolid phosphate for 6 days with that of twice-daily administration of 600 milligrams of linezolid (Zyvox®) for 10 days. Trius anticipates that the completion of the 113 study combined with the data from the 112 trial (expected in early 2012) will enable the submission of a New Drug Application (NDA) to the FDA for potential approval of tedizolid phosphate for the treatment of ABSSSI.
"The initiation of the 113 study well in advance of our initial plans has enabled us to accelerate our ABSSSI program by 9 to 12 months," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Trius. "This represents an excellent start to our Bayer collaboration and we look forward to working with them closely on the further development of tedizolid phosphate."
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.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.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 submission of an NDA for tedizolid phosphate, the timing of Trius' ABSSSI program and any future benefits arising from the Bayer collaboration. 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.