SAN DIEGO, Oct. 19, 2012 (GLOBE NEWSWIRE) -- IDWeek 2012 -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections, today announced that two studies of its lead drug candidate, tedizolid phosphate, are being presented at IDWeek 2012. The first evaluates hematological effects of tedizolid compared to linezolid (Zyvox®) and observes significantly fewer adverse platelet outcomes in patients receiving tedizolid. A second presentation examines the pharmacokinetic behavior of Trius' antibiotic in an adolescent population.
The two IDWeek reports add to the volume of safety and clinical information about tedizolid, which has progressed from the lab to the presentation of Phase 3 results in less than five years. Tedizolid, which was previously known as torezolid phosphate and TR-701, is initially being evaluated for the treatment of acute bacterial skin and skin structure infections (ABSSSI). 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 safety and efficacy data continue to indicate that tedizolid compares very favorably to linezolid," said Jeff Stein, President and Chief Executive Officer at Trius. "In addition to a significantly lower incidence of adverse platelet outcomes, patients who were treated with tedizolid experienced statistically fewer gastrointestinal adverse events than those treated with linezolid over the same number of days of exposure."
Patient Population Receiving Tedizolid has Fewer Incidences of Thrombocytopenia
The first report, "A Comparative Evaluation of Adverse Platelet Outcomes among Patients with Acute Bacterial Skin and Skin Structure Infections Receiving Tedizolid Phosphate and Linezolid," summarizes the hematological results from Trius' first Phase 3 trial, ESTABLISH-1 (TR-701-112). It shows that the incidence of platelet counts below the lower limit of normal was significantly lower in patients receiving tedizolid than those treated with linezolid. Thrombocytopenia is a well-recognized toxicity signal associated with Zyvox, so this safety profile information is of particular importance for tedizolid.
Adult Dose of Tedizolid Generates Similar Exposure in Adolescents
The second tedizolid-related report, "Population Pharmacokinetics (PK) of Oral and Intravenously Administered Tedizolid Phosphate in Adolescent Patients," evaluated the pharmacokinetics of tedizolid in adolescents. Tedizolid's high potency allows it to be administered once daily as a 200 mg oral tablet or via 200 mg IV infusion. The report concludes that the proposed adult dose of 200 mg produces tedizolid exposure in adolescents similar to healthy adults in both routes of administration.
Copies of the reports will be available on the Trius website following IDWeek at http://www.triusrx.com/trius-therapeutics-news-posters-publications-year.php.
IDWeek is the first joint meeting of the Infectious Disease Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association and the Pediatric Infectious Disease Society. It is being held in San Diego from October 17 to 21.
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 ABSSSI. Trius has two Special Protocol Assessments with the FDA for its two Phase 3 ABSSSI trials and 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.
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