WATERTOWN, Mass., June 20, 2016 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, presented results from IGNITE1 and IGNITE2, its phase 3 eravacycline clinical trials, at the American Society of Microbiology (ASM) Microbe 2016 Conference, which took place June 16-20 in Boston, MA. In total, 17 oral and poster presentations were given primarily covering clinical, preclinical and surveillance study results relating to Tetraphase’s lead drug candidate, eravacycline, and pipeline candidate, TP-271.
“The data presented this year at ASM Microbe continue to build on the body of scientific evidence supporting the efficacy and safety of intravenous (IV) eravacycline in complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI), and are supportive of our planned upcoming trials in these indications,” said Guy Macdonald, President and CEO of Tetraphase. “Notable new clinical findings from IGNITE1 include IV eravacycline’s ability to achieve successful treatment outcomes in cIAI despite the presence of concomitant bacteremia, a common confounding factor in these patients, and its efficacy against difficult-to-treat MDR Gram-negative pathogens. Significant clinical findings from IGNITE2 include both the determination that response rates increased with greater than three days of IV eravacycline, and, that in patients who received IV-only treatment, eravacycline achieved higher response rates than levofloxacin. Collectively, these clinical data will inform the design of our upcoming phase 3 trials as well as the eravacycline oral development program.”
Mr. Macdonald continued: “On the preclinical front, the comprehensive data sets presented continue to support eravacycline’s overall product profile and potent activity compared to commonly used antibiotics, particularly against drug-resistant bacteria on the U.S. Center for Disease Control and Prevention’s serious and urgent threat list, namely carbapenem-resistant Enterobacteriaceae and Acinetobacter. For TP-271, an earlier stage pipeline candidate currently in phase 1, we reported preclinical results demonstrating its efficacy in vivo against Francisella tularensis, a bacterial biothreat that can be weaponized for use in an aerosolized mass attack.”
The details for the data presentations at ASM Microbe 2016 are as follows:
Eravacycline presentations:
Poster #264: Intravenous Eravacycline With Transition To Oral Therapy for Treatment of Complicated Urinary Tract Infections (cUTI) Including Pyelonephritis: Results From A Randomized, Double-Blind, Multicenter, Phase 3 Trial (IGNITE2)
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Laboratory Diagnosis and Antimicrobial Susceptibility of UTI Pathogens
Poster #265: Intravenous Eravacycline Compared to Intravenous Levofloxacin for the Treatment of Complicated Urinary Tract Infections (cUTI): Subgroup Analysis from a Randomized, Double-Blind, Phase 3 Trial (IGNITE2)
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Laboratory Diagnosis and Antimicrobial Susceptibility of UTI Pathogens
Poster #266: Risk Factors for Change in Microbiological Outcomes between the End of Therapy (EOT) and Post-Treatment (PT) Evaluations in Patients with Complicated UTI (cUTI) Treated with Eravacycline (ERV): Analysis from a Randomized, Double-Blind, Phase 3 Trial (IGNITE2)
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Laboratory Diagnosis and Antimicrobial Susceptibility of UTI Pathogens
Poster #426: Evaluation of Patients with Complicated Intra-abdominal Infections (cIAI) and Concomitant Bacteremia (CB) from IGNITE1: A Phase 3 Study to Evaluate the Efficacy and Safety of Eravacycline (ERV) versus Ertapenem (ETP) in Complicated Intra-Abdominal Infections (cIAI)
Date and time: Friday, June 17 from 12:30 - 2:30 p.m. ET
Session info: Evaluation of Clinical Outcomes among Patients with Gram-negative Bloodstream and Complicated Infections
Poster #451: Patient Outcomes with Complicated Intra-Abdominal Infections (cIAI) Caused by Gram-Negative Pathogens from IGNITE1: A Phase 3 Study to Evaluate the Efficacy and Safety of Eravacycline (ERV) versus Ertapenem (ETP)
Date and time: Saturday, June 18 from 12:45 - 2:45 p.m. ET
Session info: Facing Resistance with New Antibacterial Agents and Non-antibiotic Approaches
Poster #005: In Vitro Activity of Eravacycline and Comparators Against Enterobacteriaceae, Including Strains Resistant to Carbapenems or 3rd/4th Generation Cephalosporins in the US
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Antimicrobial Susceptibility Testing of Newer and ReNewed Antimicrobial Agents
Poster #007: In Vitro Activity of Eravacycline and Comparators Against Acinetobacter baumannii, Including Carbapenem-resistant Strains, and Stenotrophomonas maltophilia Isolated from Patients in the US
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Antimicrobial Susceptibility Testing of Newer and ReNewed Antimicrobial Agents
Poster #008: Eravacycline In Vitro Activity Against Clinical Isolates Obtained from Genitourinary (GU) and Gastrointestinal (GI) Sources from Patients in the US
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Antimicrobial Susceptibility Testing of Newer and ReNewed Antimicrobial Agents
Poster #566: Eravacycline is Active against MDR, Cephalosporin- and Carbapenem- Resistant Enterobacteriaceae and Acinetobacter baumannii
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Tetracyclines, Aminoglycosides, and Related Compounds
Poster #550: Eravacycline In Vitro Antibacterial Activity against 110 Carbapenemase-Producing Enterobacteriaceae Clinical Isolates
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Tetracyclines, Aminoglycosides, and Related Compounds
Poster #568: Activity of Eravacycline and Comparators against 6,338 Pathogens Isolated from Canadian Hospitals: Canward 2014 and 2015
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Tetracyclines, Aminoglycosides, and Related Compounds
Poster #511: Antibacterial Efficacy of Eravacycline (ERV) In Vivo Against Gram-positive and Gram-negative Organisms
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Pharmacokinetic/Pharmacodynamic (PK/PD) of New Drugs
Oral presentation title: Eravacycline (ERV) Pharmacokinetics (PK) and Challenges in Defining Humanized Exposure In Vivo
Date, time and location: Sunday, June 19 at 8:45 a.m. ET, Meeting Room 156A
Session info: Innovations and Challenges in Pharmacokinetics/Pharmacodynamics (PK/PD)
TP-271 presentation:
Poster #563: TP-271 is Efficacious in a Francisella tularensis Cynomolgus Monkey Treatment Model
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Tetracyclines, Aminoglycosides, and Related Compounds
Additional presentations:
Oral presentation title: The Impact of ramR Sequence Variations on Tigecycline Susceptibility in Klebsiella pneumoniae
Date, time and location: Monday, June 20 at 8:15 a.m. ET, Meeting Room 157A
Session info: RNA Modulation and Cellular Signals in Antimicrobial Resistance
Poster #140: Multidrug Resistance Gram-negative (MDR-GN) Organisms in the Inpatient and Outpatient Settings in the US: 2008-2015
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Drugs, Bugs, Body Sites and Antibiograms
Poster #145: Multidrug-resistance Acinetobacter baumannii (MDR AB) Trends from All Sources in the Inpatient and Outpatient Setting in US Hospitals: 2008-2015
Date and time: Monday, June 20 from 12:30 - 2:30 p.m. ET
Session info: Drugs, Bugs, Body Sites and Antibiograms
Electronic copies of the oral and poster presentations are available upon request by emailing medinfo@tphase.com.
ASM Microbe 2016 is the integration of two of the American Society of Microbiology's meetings: the General Meeting and ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy).
About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening bacterial infections, including those caused by many of the multidrug-resistant (MDR) bacteria highlighted as urgent public health threats by the CDC. Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase's pipeline includes eravacycline, its lead antibiotic candidate in phase 3 clinical trials, as well as two additional antibiotic candidates, TP-271 and TP-6076. Please visit www.tphase.com for more company information.
Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "anticipates," "believes," "expects," "plans," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether results obtained in preclinical studies and early or interim clinical trials will be indicative of results obtained in future clinical trials; whether eravacycline will advance through the clinical trial process; whether the results of the Company's development efforts will warrant regulatory submission and whether any such submissions will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; and other factors discussed in the "Risk Factors" section of our quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on May 4, 2016. In addition, the forward-looking statements included in this press release represent our views as of June 20, 2016. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.