Trius Announces Publication of Tedizolid ESTABLISH 1 Trial in JAMA
Tedizolid Achieves All FDA and EMA Endpoints in First Phase 3 Trial Conducted Under New Draft Guidance for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
SAN DIEGO, Feb. 12, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery and development of innovative antibiotics for serious infections, announced today that the results from ESTABLISH 1, a Phase 3 study of tedizolid phosphate (TR-701) versus linezolid (Zyvox®) completed in 2011, have been published in The Journal of the American Medical Association (JAMA).
The ESTABLISH 1 trial examined the efficacy and safety of a 200 mg tablet of tedizolid given once a day for six days versus a 600 mg tablet of linezolid given twice a day for 10 days in 667 patients in North America, Latin America and Europe. The trial was the first pivotal study conducted to prospectively measure the new FDA "early response" primary endpoint of cessation of lesion spread and absence of fever 48-72 hours after the first dose. The trial also measured as secondary endpoints this "early response" sustained to the end of therapy (EOT; day 11) as well as captured the EMA endpoint of clinical investigator's assessment at the post-treatment evaluation visit (7-14 days after EOT).
As detailed in the JAMA article, tedizolid achieved the primary and all secondary endpoints in the ESTABLISH 1 trial. Approximately 42 percent of pathogens isolated at baseline in the study were methicillin resistant Staphylococcus aureus (MRSA). For both tedizolid and linezolid there was good concordance (>80%) between the early primary endpoint and late investigator assessed secondary endpoints suggesting that the early response is a good indicator of a sustained clinical response to therapy. In addition, the trial showed that tedizolid had a statistically lower impact on platelets and was associated with a statistically significant lower rate of gastrointestinal (GI) adverse events than linezolid.
"While being the pioneer on a pivotal study conducted under new guidance offers many challenges, the results speak for themselves and are a testimony to the extraordinary efforts of the Trius team working in concert with the FDA," said Philippe Prokocimer, M.D., Chief Medical Officer at Trius and lead author of the JAMA article. "Publication of the ESTABLISH 1 trial results in JAMA further confirms the need for new antibiotics such as tedizolid."
In an accompanying editorial in the JAMA issue, Drs. Shira Doron and Helen Boucher state, "Much can be learned from the current study about the appropriate use of antibiotics for the treatment of these common infections, and the design of future trials for treatment of ABSSSI." They also highlight that "Tedizolid is a new oral antibiotic that appears efficacious using a short course of therapy and may have a better safety profile than linezolid."
In December 2012, Trius announced that it completed enrollment of its second ABSSSI trial, ESTABLISH 2. This second pivotal Phase 3 trial was designed to evaluate the efficacy and safety of tedizolid and linezolid when initially administered as an intravenous (IV) infusion with the option to switch to oral therapy. Trius expects to report top-line results from the ESTABLISH 2 study around the end of the first quarter of this year.
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused on the discovery and development of innovative antibiotics for serious infections. The Company's lead investigational drug, tedizolid phosphate, is a once daily, IV and orally administered second generation oxazolidinone 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. 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 the following: Trius' ability to successfully complete its ongoing clinical trials and development programs; gaining FDA approval for tedizolid; and transitioning 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.
CONTACT: Public Relations Contact: Laura Kempke/Andrew Law at MSLGROUP firstname.lastname@example.org 781-684-0770 Investor Relations Contact: Stefan Loren at Westwicke Partners, LLC email@example.com 443-213-0507