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 data from four abstracts will be
presented at the 39th Annual Meeting of the Surgical Infection
Society (SIS) taking place June 5-8, 2019 in Coronado, Calif.
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).
The details for the presentations at SIS are as follows:
Poster title: Factors That Impact Duration of Antibiotic
Therapy From Phase 3 Studies of Eravacycline for Intra-Abdominal
InfectionPresenter: Kenneth Lawrence, PharmDSession:
Bugs and DrugsDate and time: Saturday, June 8 from 8:30 –
9:30 a.m. PTPoster number: P24
Poster title: 2017 Global Surveillance of the In Vitro
Activity of Eravacycline Against Clinical Isolates From
Gastrointestinal InfectionsPresenter: Steven Kolkin,
PharmDSession: Bugs and DrugsDate and time: Saturday,
June 8 from 8:30 – 9:30 a.m. PTPoster number: P26
Poster title: Efficacy of Eravacycline in Non-Appendiceal
Complicated Intra-Abdominal Infections: An Analysis of Two Phase 3
TrialsPresenter: Vanessa Grant-DiFelice, M.D.Session:
Bugs and DrugsDate and time: Saturday, June 8 from 8:30 –
9:30 a.m. PTPoster number: P28
Poster title: Microbiology and Outcomes of
Hospitalization with Intra-Abdominal Infections in the U.S.: A
Retrospective Cohort StudyPresenter: Melanie Olesky,
Ph.D.Session: Bugs and DrugsDate and time: Saturday,
June 8 from 8:30 – 9:30 a.m. PTPoster number: P23
Additional Activities:
- Tetraphase will sponsor an luncheon
symposium at SIS on Friday, June 7 from 12:00 – 1:15 p.m. PT
located in Commodore E. Donald E. Fry M.D., will be leading the
session with a talk titled "Getting it Wrong" in which he will
discuss the impact of inappropriate empiric treatment for patients
with cIAI. Vanessa Ho, M.D., will follow with a discussion focusing
on a review of newer antibiotics for cIAI, titled "Getting it
Right."
- Tetraphase will host a XERAVA exhibit
booth (#2) at SIS 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
whether preclinical data is indicative of expected clinical data;
our cash resources and the expected revenue will be sufficient to
fund our operations in the future; our product candidates will
succeed in clinical trials; even if such clinical trials are
successful, whether we may ever achieve regulatory approval of such
product candidates; and other 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 May 29, 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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version on businesswire.com: https://www.businesswire.com/news/home/20190529005078/en/
Media and Investor Contact:Jennifer
Vierajviera@tphase.com617-600-7040
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