SAN DIEGO, April 23, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX) announced today that the results of a large, late-stage human study, called ESTABLISH 2, and multiple other clinical studies from its experimental antibiotic, tedizolid phosphate (TR-701), will be presented in poster and oral presentations at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin from April 27-30. A total of three tedizolid-related posters and one oral presentation have been accepted for presentation, including clinical and safety results.
The clinical abstracts examine the effect of tedizolid in patients with acute bacterial skin and skin structure infections (ABSSSI), as well as cardiac and medication interaction safety trials. The abstracts include a poster presentation from the ESTABLISH 2 trial, the second of two late-stage or Phase 3 studies needed for U.S. and E.U. regulatory filings. As in the ESTABLISH 1 study, which tested the pill form of tedizolid, the ESTABLISH 2 intravenous (IV) to pill transition study captured the endpoints for ABSSSI established by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These presentations mark the first time ESTABLISH 2 data are being presented at a major medical meeting. Top-line results, reported in March 2013, showed that tedizolid achieved all primary and secondary efficacy outcomes after a short course of therapy using one-tenth the amount of total drug versus the comparator linezolid (Zyvox®). Patients receiving tedizolid also showed numerical improvements in key safety and tolerability measurements in the complete study population.
"The results of ESTABLISH 2 combined with those from ESTABLISH 1 and additional clinical studies support the differentiated profile of tedizolid as a potential new treatment option for patients with severe skin infections," said Dr. Philippe Prokocimer, Chief Medical Officer of Trius.
Tedizolid is the company's lead product candidate. It is a once daily, IV and orally administered oxazolidinone being developed for the treatment of serious gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
The presentations are as follows:
Saturday, April 27th
Poster Session – PK/PD: New Drugs, the Critically and Resistant Bugs (3:30 p.m. – 4:30 p.m.)
- P 921: Lack of pharmacokinetic drug interaction of tedizolid phosphate with pseudoephedrine in healthy subjects; S. Flanagan, S. Minassian, K.A. Munoz, H. Dreskin, E. Fang, P. Prokocimer
Sunday, April 28th
Poster Session – Late Breaking News (1:30 p.m. – 2:30 p.m.)
- LB 2964: Efficacy and safety results from the ESTABLISH 2 ABSSSI study comparing IV and oral tedizolid phosphate and linezolid; E. Fang, C. De Anda, A. Das, P. Prokocimer
Poster Session – New Antibacterial Agents Other than Beta-lactams (1:30 p.m. – 2:30 p.m.)
- P 1648: Effects of oral tedizolid phosphate on QTcF and other electrocardiogram (ECG) parameters; E. Fang, J. Litwin, W. Lewis, C. Casseday, S.L. Minassian, S. Flanagan, P. Prokocimer
Monday, April 29th
Oral Presentation – Emerging Resistance in Gram-Positive Bacteria (11:30 a.m. – 12:30 p.m.)
- O 449: Identification and characterization of linezolid-resistant Staphylococcus aureus 3133832, the first known clinical isolate possessing the cfr multidrug-resistance gene; K. Shaw, J. Locke, D. Zuill, D. Sahm, J. Deane, G. A. Denys
Copies of these posters will be available on the Trius website following the ECCMID meeting: 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.
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.
CONTACT: Public Relations Contact: Laura Kempke/Andrew Law at MSLGROUP email@example.com 781-684-0770 Investor Relations Contact: Stefan Loren at Westwicke Partners, LLC firstname.lastname@example.org 443-213-0507Source:Trius Therapeutics, Inc.