SAN DIEGO and BERLIN, April 29, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery and development of antibiotics for serious infections, announced a range of clinical data for the experimental antibiotic tedizolid phosphate (TR-701) and a presentation on linezolid (Zyvox®)-resistant strain of bacteria. This took place at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin.
In addition to the detailed efficacy and safety results of the ESTABLISH-2 study, which build upon the top-line results previously announced, Trius presented the results of a drug interaction clinical study demonstrating that tedizolid phosphate does not increase blood pressure when used in conjunction with vasoconstrictor drugs such as decongestants. In addition, the results of a separate clinical cardiovascular safety study showed that tedizolid is not associated with heart beat abnormalities at up to six times its effective dose, the maximum dose examined in the study. The results of both studies further support the safety profile for tedizolid. In addition, in an oral presentation, Trius provided an overview of data on an emerging class of bacterial pathogens that is resistant to linezolid (Zyvox), the only marketed drug of the same class as tedizolid. To date, these strains have proven susceptible to tedizolid.
"There has been a significant need for new antibiotic therapies targeting resistant bacterial infections, such as MRSA," said Jeffrey Stein, Ph.D., CEO and President of Trius Therapeutics. "We are very excited to share these results, which build upon and are consistent with those from our first Phase 3 study. These combined results show that tedizolid phosphate represents a potential new therapy to treat severe skin infections with a once daily intravenous infusion or pill in fewer days than existing antibiotic medications. Combined with the results of our multiple other clinical and nonclinical studies, we believe that tedizolid may offer substantial benefits to patients and, potentially, payers and the healthcare system."
"The data demonstrate that in this trial tedizolid was safe and effective and allowed patients to rapidly transition from an intravenous to pill therapy," said Philippe Prokocimer, M.D., Chief Medical Officer at Trius. "The combined results of all of our clinical studies are remarkably consistent, and support tedizolid as a well-tolerated, short-course therapy for acute bacterial skin infections."
Copies of the posters are available on the Trius website: http://www.triusrx.com/trius-therapeutics-news-posters-publications-year.php.
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious infections. The Company's lead investigational drug, tedizolid phosphate, is a novel antibiotic 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 Investigational New Drug (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, Klebsiella, Acinetobacter and Pseudomonas. 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 anticipated effects of the addition of Mr. Fischer to the Company's Board of Directors and the Company's commercialization efforts. 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; additional ongoing or planned clinical trials of tedizolid phosphate may produce negative or inconclusive results; Trius may decide, or the FDA may require Trius, to conduct additional clinical trials or to modify Trius' ongoing clinical trials; Trius may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Trius' ability to obtain regulatory approval; the third parties with whom Trius has partnered with for the development of tedizolid phosphate and upon whom Trius relies to conduct its clinical trials and manufacture its product candidates may not perform as expected; tedizolid phosphate may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid phosphate could delay or prevent regulatory approval or commercialization; 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 recent 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.