WATERTOWN, Mass.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24TTPH&src=ctag" target="_blank"gt;$TTPHlt;/agt; lt;a href="https://twitter.com/hashtag/antibioticresistance?src=hash" target="_blank"gt;#antibioticresistancelt;/agt;–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 Infection
Presenter:
Kenneth Lawrence, PharmD
Session: Bugs and Drugs
Date
and time: Saturday, June 8 from 8:30 – 9:30 a.m. PT
Poster
number: P24
Poster title: 2017 Global Surveillance of the In Vitro
Activity of Eravacycline Against Clinical Isolates From Gastrointestinal
Infections
Presenter: Steven Kolkin, PharmD
Session:
Bugs and Drugs
Date and time: Saturday, June 8 from 8:30 –
9:30 a.m. PT
Poster number: P26
Poster title: Efficacy of Eravacycline in Non-Appendiceal
Complicated Intra-Abdominal Infections: An Analysis of Two Phase 3 Trials
Presenter:
Vanessa Grant-DiFelice, M.D.
Session: Bugs and Drugs
Date
and time: Saturday, June 8 from 8:30 – 9:30 a.m. PT
Poster
number: P28
Poster title: Microbiology and Outcomes of Hospitalization with
Intra-Abdominal Infections in the U.S.: A Retrospective Cohort Study
Presenter:
Melanie Olesky, Ph.D.
Session: Bugs and Drugs
Date
and time: Saturday, June 8 from 8:30 – 9:30 a.m. PT
Poster
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.
Contacts
Media and Investor Contact:
Jennifer Viera
jviera@tphase.com
617-600-7040