Trius Therapeutics to Present Data From Antibiotics Development Programs at ICAAC 2013
07 September 2013 - 6:01AM
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 53rd
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.
CONTACT: Public Relations Contact:
Laura Kempke at MSLGROUP
trius@mslgroup.com
781-684-0770
Investor Relations Contact:
Stefan Loren at Westwicke Partners, LLC
sloren@westwicke.com
443-213-0507
Trius Therapeutics, Inc. (MM) (NASDAQ:TSRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Trius Therapeutics, Inc. (MM) (NASDAQ:TSRX)
Historical Stock Chart
From Jul 2023 to Jul 2024