SAN DIEGO, Sept. 6, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq: TSRX ), a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for serious infections, announced today that results of clinical studies of its lead antibiotic candidate, tedizolid phosphate, will be presented this week at the 53 rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Denver. Seven poster and slide sessions regarding tedizolid have been accepted for presentation. Trius researchers will also present a poster on cfr resistance and two poster sessions on the company's GyrB/ParE antibacterial program, which targets Gram-negative pathogens.
Tedizolid 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). A highlight of Trius' presentations at ICAAC will be the discussion of integrated efficacy and safety data from two separate Phase 3 studies, ESTABLISH 1 and ESTABLISH 2, which enrolled a total of 1,333 patients from the U.S., Europe and other regions. As has been previously reported, non-inferiority to linezolid was met with the primary endpoint and all secondary endpoints defined by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
"Pooled data from these two pivotal studies continue to support the use of tedizolid as a potential treatment for ABSSSI, subject to approval by the FDA and EMA," said Dr. Philippe Prokocimer, Chief Medical Officer of Trius. "The data from these studies and the 9 month neurotoxicity animal study results presented at this meeting are particularly compelling."
Trius researchers will also discuss research on the cfr gene, which currently confers resistance to six classes of antibiotics. Cfr represents the first horizontally transferable resistance determinant for linezolid; however, despite being in the same drug class as linezolid, tedizolid does not fall within the cfr resistance spectrum. At ICAAC, Trius will present the results of an examination of drug-resistant bacteria collected at a New York medical center.
Presentations from Trius researchers and collaborators are as follows:
Tuesday, September 10th
Poster Presentations (12:00-2:00 p.m.)
- C2-090 : Activity of Tedizolid (TZD) and Linezolid (LZD) Against Key Bacterial Pathogens Associated with Respiratory, Skin/Wound Infections, and Bacteremia; J. Deane, C. Opiela, D. Shah, K. Shaw, J. Locke, D. Sahm
- L-203 : Integrated Results from Phase 3 Studies Comparing Tedizolid 6 Days vs Linezolid 10 Days in Patients with ABSSSI; C. De Anda, E. Fang, A. Das, P. Prokocimer
- A-017c : Tedizolid Population Pharmacokinetics, Exposure-Response, and Target Attainment; S. Flanagan, J. Passarell, Q. Lu, J. Fiedler-Kelly, P. Prokocimer
- A-017b : Lack of Neuropathy After Long-Term Tedizolid Administration in Rats; H. Hosako, A. Radovsky, D. Draganov, J. Vija, K. Bartizal
- E-143 : In Vitro Activity of Tedizolid Against Canadian Clinical Gram-Positive Pathogens, Including hVISA and the CDC NARSA Strains; A. Golden, M. Baxter, K. Nichol, H. Adam, D. Hoban, G. Zhanel
Slide Session (5:30-5:45 p.m.)
- C1:312 : Sub-Inhibitory Concentrations of Tedizolid Slow the Emergence of Daptomycin Non-Susceptibility in Methicillin-Resistant Staphylococcus aureus ; J. Locke, D. Zuill, K. Shaw
Wednesday, September 11th
Symposium – New Twists to Topoisomerase Inhibitors (9:30-10:00 a.m.)
- F-409 : Novel GyrB/ParE Inhibitors; J. Finn
Poster Presentations (11:00 a.m.-1:00 p.m.)
- C1:517 : Characterization of cfr -Positive Linezolid-Resistant USA300 Staphylococcus aureus Isolates Collected From a New York City Medical Center; J. Locke, D. Zuill, C. Scharn, J. Deane, D. Sahm, S. Jenkins, R. Goering, K. Shaw
- E-621 : Comparative Efficacy of Tedizolid (TDZ), Linezolid (LZD), and Vancomycin in a Murine Model of Catheter-Related Biofilm Infection Due to Staphylococcus aureus (SA): Microbiological and Bioluminescent Assessments; Y. Xiong, W. Hady, K. Bartizal, A. Bayer
Thursday, September 12th
Poster Presentations (11:00 a.m.-1 p.m.)
- F-1222 : Characterization of Escherichia coli GyrB Mutants Selected by Tricyclic GyrB/ParE (TriBE) Inhibitors; M. Cunningham, A. Castellano, D. Bensen, S. Rodriguez, B. Kwan, V. Brown-Driver, L. Tari, J. Finn, J. Shaw
- F-1221 : Novel Dual-Targeting Gyrase/Topoisomerase IV Inhibitors: Correlation of ParE Potency vs. the Spontaneous Mutation Frequency in E. coli ; A. Castellano, M. Cunningham, B. Kwan, M. Trzoss, T. Lam, Z. Chen, X. Li, V. Brown-Driver, K. Shaw
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 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and serious Gram-positive infections, including those caused by methicillin-resistant staphylococcus aureus (MRSA). Trius has completed two Phase 3 ABSSSI trials for which it has Special Protocol Assessments with the FDA and has partnered with Bayer Pharma 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 GyrB/ParE 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 Trius' ability to successfully complete its ongoing clinical trials and development programs, the potential for tedizolid as a treatment for ABSSSI. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Trius' preclinical studies and clinical trials; regulatory developments in the United States and foreign countries, including the risk that regulators may not agree with Trius' conclusions regarding its clinical and non-clinical study results; any negative or inconclusive results of ongoing or planned clinical trials of Trius' product candidates; additional clinical trials or the modification Trius' ongoing clinical trials decided upon by Trius or required by the FDA or EMA; delays in the commencement, enrollment, completion or analysis of clinical testing for Trius' 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; any failure of expected performance by the third parties with whom Trius has partnered with for the development of its product candidates and upon whom Trius relies to conduct its clinical trials and manufacture its product candidates; the failure of tedizolid phosphate to receive regulatory approval or to be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid phosphate that could delay or prevent regulatory approval or commercialization; 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.
Public Relations Contact: Laura Kempke at MSLGROUP 781-684-0770 Investor Relations Contact: Stefan Loren at Westwicke Partners, LLC 443-213-0507
