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
2017Presenter: Sara Hwang, Pharm.D.Track:
Antimicrobial Agents and ResistanceSub-track: AAR01 –
Surveillance of Antimicrobial Resistance: Molecular Typing/Clinical
and Molecular EpidemiologyDate and time: Friday, June 21
from 10:30 a.m. – 5:00 p.m. PTSession type: Poster
PresentationPoster number: AAR-543
Poster title: Activity of Eravacycline and Comparators
Against 15,887 Bacterial Pathogens Isolated From Patients Receiving
Care in Canadian Hospitals: CANWARD 2014-2018Presenter:
George G. Zhanel, Pharm.D., Ph.D.Track: Antimicrobial Agents
and ResistanceSub-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. PTSession
type: Poster PresentationPoster number: AAR-790
Poster title: Multicenter Evaluation of Eravacycline MIC
Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative
MIC PanelsPresenter: Jennifer Y. Chau, Ph.D.Track:
Clinical and Public Health MicrobiologySub-track: CPHM02 –
Antimicrobial Susceptibility TestingDate and time: Sunday,
June 23 from 10:30 a.m. – 4:00 p.m. PTSession type: Poster
PresentationPoster number: CPHM-862
Poster title: First Comparative Evaluation of ETEST® ERV
bioMérieux With the CLSI Broth Microdilution Method for
Eravacycline MIC DeterminationPresenter: Edwige Pillon,
bioMérieux S.A.; Marcy l’Etoile, FranceTrack: Clinical and
Public Health MicrobiologySub-track: CPHM02 – Antimicrobial
Susceptibility TestingDate and time: Sunday, June 23 from
10:30 a.m. – 4:00 p.m. PTSession type: Poster
PresentationPoster 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-ResistancePresenter:
Brian D. JohnstonTrack: Antimicrobial Agents and
ResistanceSub-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. PTSession
type: Poster PresentationPoster number: AAR-768
Poster title: Efficacy of TP-6076 in the Murine Thigh
Infection Model With Acinetobacter baumanniiPresenter: Mark
E. PulseTrack: Antimicrobial Agents and
ResistanceSub-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. PTSession type: Poster PresentationPoster
number: AAR-787
Poster title: Pharmacokinetics and Efficacy of TP-6076 in
the Murine Lung Infection Model With Acinetobacter
baumanniiPresenter: William J. Weiss, M.S.Track:
Antimicrobial Agents and ResistanceSub-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. PTSession type: Poster
PresentationPoster number: AAR-788
Symposium Presentation: Pharmacokinetics and Efficacy of
TP-6076 in the Murine Lung Infection Model With Acinetobacter
baumanniiPresenter: William J. Weiss, M.S.Track:
Antimicrobial Agents and ResistanceSub-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. PTSession: 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.
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