WATERTOWN, Mass.–(BUSINESS WIRE)–$TTPH #antibioticresistance—Tetraphase
Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company
focused on developing and commercializing novel tetracyclines to treat
serious and life-threatening conditions, today announced that new data
will be presented at the American Society for Microbiology (ASM) Microbe
2019 Annual Meeting, taking place June 20-24 in San Francisco.
Presentations will include data on XERAVATM (eravacycline), a
novel, fully synthetic fluorocycline approved by the U.S. Food and Drug
Administration and the European Medicines Agency for the treatment of
complicated intra-abdominal infections (cIAI), and TP-6076, a
clinical-stage candidate in development to target multidrug-resistant
infections.
The details for the presentations at ASM Microbe are as follows:
Poster title: Global In Vitro Surveillance of Eravacycline
Against Gram-Negative and Gram-Positive Clinical Isolates, Including
Multidrug-Resistant Pathogens, Collected in 2017
Presenter:
Sara Hwang, Pharm.D.
Track: Antimicrobial Agents and
Resistance
Sub-track: AAR01 – Surveillance of Antimicrobial
Resistance: Molecular Typing/Clinical and Molecular Epidemiology
Date
and time: Friday, June 21 from 10:30 a.m. – 5:00 p.m. PT
Session
type: Poster Presentation
Poster number: AAR-543
Poster title: Activity of Eravacycline and Comparators Against
15,887 Bacterial Pathogens Isolated From Patients Receiving Care in
Canadian Hospitals: CANWARD 2014-2018
Presenter: George G.
Zhanel, Pharm.D., Ph.D.
Track: Antimicrobial Agents and
Resistance
Sub-track: AAR09 – Pharmacological Studies of
Investigational Agents Pre-NDA (Phase 2/3)
Date and time:
Saturday, June 22 from 10:30 a.m. – 5:00 p.m. PT
Session type:
Poster Presentation
Poster number: AAR-790
Poster title: Multicenter Evaluation of Eravacycline MIC Results
for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC
Panels
Presenter: Jennifer Y. Chau, Ph.D.
Track: Clinical
and Public Health Microbiology
Sub-track: CPHM02 –
Antimicrobial Susceptibility Testing
Date and time: Sunday,
June 23 from 10:30 a.m. – 4:00 p.m. PT
Session type: Poster
Presentation
Poster number: CPHM-862
Poster title: First Comparative Evaluation of ETEST®
ERV bioMérieux With the CLSI Broth Microdilution Method for Eravacycline
MIC Determination
Presenter: Edwige Pillon, bioMérieux S.A.;
Marcy l’Etoile, France
Track: Clinical and Public Health
Microbiology
Sub-track: CPHM02 – Antimicrobial
Susceptibility Testing
Date and time: Sunday, June 23 from
10:30 a.m. – 4:00 p.m. PT
Session type: Poster Presentation
Poster
number: CPHM-865
Poster title: Activity of Cefiderocol (CFDC),
Ceftazidime-Avibactam (CZA), and Eravacycline (ERV) Against
Carbapenem-Resistant (CR) E. coli Isolates From the U.S.: Clonal
Background, Resistance Genes, and Co-Resistance
Presenter:
Brian D. Johnston
Track: Antimicrobial Agents and Resistance
Sub-track:
AAR09 – Pharmacological Studies of Investigational Agents Pre-NDA (Phase
2/3)
Date and time: Saturday, June 22 from 10:30 a.m. – 5:00
p.m. PT
Session type: Poster Presentation
Poster
number: AAR-768
Poster title: Efficacy of TP-6076 in the Murine Thigh Infection
Model With Acinetobacter baumannii
Presenter: Mark E.
Pulse
Track: Antimicrobial Agents and Resistance
Sub-track:
AAR08 – New Antimicrobial Agents (In Vitro and In Vivo
Studies Prior to the Start of Clinical Therapy)
Date and time:
Friday, June 21 from 10:30 a.m. – 5:00 p.m. PT
Session type:
Poster Presentation
Poster number: AAR-787
Poster title: Pharmacokinetics and Efficacy of TP-6076 in the
Murine Lung Infection Model With Acinetobacter baumannii
Presenter:
William J. Weiss, M.S.
Track: Antimicrobial Agents and
Resistance
Sub-track: AAR08 – New Antimicrobial Agents (In
Vitro and In Vivo Studies Prior to the Start of Clinical
Therapy)
Date and time: Friday, June 21 from 10:30 a.m. –
5:00 p.m. PT
Session type: Poster Presentation
Poster
number: AAR-788
Symposium Presentation: Pharmacokinetics and Efficacy of TP-6076
in the Murine Lung Infection Model With Acinetobacter baumannii
Presenter:
William J. Weiss, M.S.
Track: Antimicrobial Agents and
Resistance
Sub-track: AAR09 – Pharmacological Studies of
Investigational Agents Pre-NDA (Phase 2/3)
Date and time:
Sunday, June 23 from 3:30 p.m. – 3:45 p.m. PT
Session: S339
– Pipeline Drugs to Treat Gram-negative Infections
Additional Activities:
-
Tetraphase will host a XERAVA exhibit booth (#343) at ASM during
exhibit hours.
About XERAVATM
XERAVA (eravacycline for injection) is a tetracycline class
antibacterial indicated for the treatment of complicated intra-abdominal
infections (cIAI) in patients 18 years of age and older. XERAVA was
investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating
Gram-Negative Infections Treated with Eravacycline)
Phase 3 program. In the first pivotal Phase 3 trial in patients with
cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by
demonstrating statistical non-inferiority of clinical response compared
to ertapenem and was well-tolerated. In the second Phase 3 clinical
trial in patients with cIAI, twice-daily IV XERAVA met the primary
endpoint by demonstrating statistical non-inferiority of clinical
response compared to meropenem and was well-tolerated. In both trials,
XERAVA achieved high cure rates in patients with Gram-negative
pathogens, including resistant isolates.
Indications and Usage
XERAVA is indicated for the treatment of complicated intra-abdominal
infections (cIAI) caused by susceptible microorganisms: Escherichia
coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae,
Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium,
Staphylococcus aureus, Streptococcus anginosus group, Clostridium
perfringens, Bacteroides species, and Parabacteroides
distasonis in patients 18 years or older.
Limitations of Use
XERAVA is not indicated for the treatment of complicated urinary tract
infections (cUTI).
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of XERAVA and other antibacterial drugs, XERAVA should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. When culture and
susceptibility information are available, they should be considered in
selecting or modifying antibacterial therapy. In the absence of such
data, local epidemiology and susceptibility patterns may contribute to
the empiric selection of therapy.
Important Safety Information
XERAVA is contraindicated for use in patients with known
hypersensitivity to eravacycline, tetracycline-class antibacterial
drugs, or to any of the excipients. Life-threatening hypersensitivity
(anaphylactic) reactions have been reported with XERAVA.
The use of XERAVA during tooth development (last half of pregnancy,
infancy and childhood to the age of eight years) may cause permanent
discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of XERAVA during the second and third trimester of pregnancy,
infancy and childhood up to the age of eight years may cause reversible
inhibition of bone growth.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range in
severity from mild diarrhea to fatal colitis.
The most common adverse reactions observed in clinical trials (incidence
≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting
(3.7%).
XERAVA is structurally similar to tetracycline-class antibacterial drugs
and may have similar adverse reactions. Adverse reactions including
photosensitivity, pseudotumor cerebri, and anti-anabolic action which
has led to increased BUN, azotemia, acidosis, hyperphosphatemia,
pancreatitis, and abnormal liver function tests, have been reported for
other tetracycline-class antibacterial drugs, and may occur with XERAVA.
Discontinue XERAVA if any of these adverse reactions are suspected.
To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase
Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for XERAVA at www.XERAVA.com.
About Tetraphase Pharmaceuticals, Inc.
Tetraphase Pharmaceuticals, Inc., is a biopharmaceutical company using
its proprietary chemistry technology to create novel tetracyclines for
serious and life-threatening conditions, including infections caused by
many of the multidrug-resistant bacteria highlighted as urgent public
health threats by the World Health Organization and the Centers for
Disease Control and Prevention. The Company has created more than 3,000
novel tetracycline compounds using its proprietary technology platform.
Tetraphase’s lead product XERAVATM is approved for the
treatment of complicated intra-abdominal infections by the U.S. Food and
Drug Administration and the European Medicines Agency. The Company’s
pipeline also includes TP-271 and TP-6076, which are in Phase 1 clinical
trials, and TP-2846, which is in preclinical testing for acute myeloid
leukemia. 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, including our key
milestones for 2019 and our anticipated cash runway, 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 clinical, regulatory and commercial risk
factors discussed in the “Risk Factors” section of our quarterly report
on Form 10-Q for the period ended March 31, 2019, filed with the
Securities and Exchange Commission on May 8, 2019. In addition, the
forward-looking statements included in this press release represent our
views as of June 13, 2019. 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.
Contacts
Media and Investor Contact:
Argot Partners
Maeve
Conneighton
212-600-1902
maeve@argotpartners.com