SAN DIEGO, June 12, 2013 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company focused on the discovery, development and commercialization of antibiotics for serious infections, today announced the publication of the results of multiple clinical and animal studies showing the company's experimental antibiotic, tedizolid phosphate (TR-701), does not interact with monamine oxidase (MAO). MAO is an enzyme involved in the regulation of neurotransmitters such as serotonin, norepinephrine and dopamine, and its inhibition can lead to serious drug-drug interactions. These results were published in the July 2013 (Volume 57 Number 7) print issue of Antimicrobial Agents and Chemotherapy.
The findings suggest tedizolid, if approved, could potentially be taken with commonly prescribed medicines such as many antidepressants, whose use is limited with agents that inhibit MAO. Some other antibiotics are associated with rare but significant neurological adverse events when used with such agents. For example, linezolid (Zyvox®) exhibits drug interactions when taken with medicines that lead to increased serotonin levels, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This may cause serotonin syndrome, which is a life-threatening neurological condition. Other adverse drug reactions that may result from interactions with MAO inhibitors include hypertensive (high blood pressure) crisis caused by combination with vasoconstrictors (blood pressure medications), and hypoglycemia (low blood sugar) caused by combination with insulin or anti-diabetic medicines.
"We are encouraged that tedizolid dosed at up to 25 times above its human therapeutic use did not appear to alter MAO function in these studies," said Philippe Prokocimer, Chief Medical Officer at Trius Therapeutics. "The studies suggest that, unlike linezolid, tedizolid could be taken without restriction by patients on many common antidepressants and other medicines that inhibit MAO, subject to agreement by regulatory authorities."
Trius will include these results in its new drug application (NDA) for tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The company plans to submit the NDA to the Food & Drug Administration (FDA) in the second half of 2013.
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 Company's planned NDA filing for tedizolid and the FDA's agreement with Trius' conclusions regarding its studies relating to the interaction of tedizolid and MAO. 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; any negative or inconclusive results of additional ongoing or planned clinical trials of tedizolid phosphate; additional clinical trials or the modification Trius' ongoing clinical trials decided upon by Trius or required by the FDA; 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 tedizolid phosphate 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; 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.