Includes Results of ESTABLISH 1, the First Phase 3 Study, and Late-Breaker Exploring Monoamine Oxidase Activity
Online PR News – 13-September-2012 – SAN FRANCISCO – SAN FRANCISCO, Sept. 13, 2012 (GLOBE NEWSWIRE) -- ICAAC 2012 -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections, announced today that several abstracts related to tedizolid phosphate (TR-701) are being presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in San Francisco from September 9 to September 12, 2012. A total of 12 tedizolid-related posters have been accepted for presentation, including clinical results and preclinical studies of tedizolid against gram-positive bacterial infections.
The clinical abstracts examine the effect of tedizolid in patients with acute bacterial skin and skin structure infections (ABSSSI), as well as liver- and renal-impaired, adolescent and elderly populations. The abstracts include two poster presentations from the ESTABLISH 1 trial summarizing detailed results from Trius' first Phase 3 trial (TR-701-112) of tedizolid in patients with ABSSSI. This marks the first time these data are being presented at a major medical meeting. Top-line results, reported in December 2011, showed that tedizolid achieved all primary and secondary efficacy outcomes after a short course of therapy, and showed significant improvements in key safety and tolerability measurements in the complete study population versus the comparator linezolid (Zyvox®). This is the first of two registrational studies for tedizolid.
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).
"These data add to the growing body of evidence supporting the efficacy and safety of a six-day course of once-daily oral tedizolid," said Jeff Stein, President and Chief Executive Officer at Trius Therapeutics. "We look forward to results from our second Phase 3 study of tedizolid in ABSSSI for its intravenous to oral transition therapy. These findings may offer insights into tedizolid's benefits as a patient's treatment course shifts from hospitalization to post-discharge."
New Data Presented in Late-Breaker Poster
Trius also is presenting early-stage tedizolid data (A-1295a) in the late-breaking poster session. Two randomized, double-blind, placebo-controlled, Phase 1 crossover studies (Study TR701-114 and Study TR701-105) as well as an animal study (5-HTP Mouse Head Twitch Study) demonstrated that tedizolid does not appear to interact with monoamine oxidase (MAO) type A (MAO-A). Published studies have shown that MAO inhibition may be associated with food and drug interactions that affect blood pressure and the body's ability to regulate activity for common neurotransmitters, such as serotonin, norepinephrine and dopamine. In some cases, these interactions can be severe and life-threatening, as for serotonin syndrome.Antibiotic agents with MAO inhibiting activity such as Zyvox are contraindicated in the presence of antidepressants, Parkinson and vasopressive medicines. Tedizolid studies presented at ICAAC have shown that tedizolid treatment does not produce the hallmark signs of interaction with monoamine oxidase, and is therefore not expected to interact with these medications.
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 oxazolidinone in Phase 3 clinical development for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Trius has partnered with Bayer HealthCare for the development and commercialization of tedizolid in Asia and Emerging Markets. In addition to the company's tedizolid clinical program, Trius has initiated IND-enabling studies for its Gyrase-B/ParE development candidate. This dual-inhibitor agent has potent activity against gram-negative bacterial pathogens, including multi-drug resistant strains of E. coli, Klebsiella, Acinetobacter and Pseudomonas. The Gyrase-B program is one of the two preclinical programs supported by federal contracts. 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 Trius' ability to meet its future financing needs and successfully complete its ongoing clinical trials and development programs and transition into commercialization. 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.