WATERTOWN, Mass.–(BUSINESS WIRE)–Tetraphase
Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company
focused on developing and commercializing novel tetracyclines to treat
serious and life-threatening conditions, today announced five data
presentations at the 22nd Annual MAD-ID (Making a Difference
in Infectious Diseases) Meeting, taking place May 8-11, 2019 in Orlando,
Fla. 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.
The details for the data presentations at MAD-ID are as follows:
Poster title: Eravacycline is Effective in High-Risk Complicated
Intra-Abdominal Infection Subgroups
Date and time: Thursday,
May 9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster
number: 75 E
Poster title: Efficacy of Eravacycline in Obese Patients: Pooled
Analysis of IGNITE1 and IGNITE4
Date and time: Thursday, May
9 from 5:00 – 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster
number: 74 E
Poster title: Effect of Renal Function in IGNITE1 and IGNITE 4:
Two Phase 3 Studies to Evaluate the Efficacy and Safety of Eravacycline
Date
and time: Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location:
Grand Ballroom CDE
Poster number: 73 E
Poster title: Micro Efficacy of Eravacycline Against Enterobacteriaceae
and Acinetobacter, Including MDR Isolates: A Pooled Analysis from
IGNITE1 and IGNITE4
Date and time: Thursday, May 9 from 5:00
– 6:30 p.m. ET
Location: Grand Ballroom CDE
Poster
number: 76 E
Poster title: Multi-Site Evaluation of Eravacycline MIC Test
Strip Compared to Broth Microdilution for Enterobacteriaceae, S.
aureus and Enterococcus spp.
Date and time:
Thursday, May 9 from 5:00 – 6:30 p.m. ET
Location: Grand
Ballroom CDE
Poster number: 72 OR
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 8 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 8 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
This press release contains forward-looking statements including
statements related to our overall strategy, products, prospects and
potential. All statements, other than statements of historical facts,
included in this press release are forward-looking statements, and are
identified by words such as “advancing,” “expect,” “look forward,”
“anticipate,” “continue,” and other words and terms of similar meaning.
These forward-looking statements are based upon our current expectations
and involve substantial risks and uncertainties. We may not actually
achieve the plans, carry out the intentions or meet the expectations or
projections disclosed in our forward-looking statements and you should
not place undue reliance on these forward-looking statements. Our actual
results and the timing of events could differ materially from those
included in such forward-looking statements as a result of these risks
and uncertainties. These and other risk factors are discussed under
“Risk Factors” and elsewhere in our Annual Report on Form 10-K for the
year ended December 31, 2018, filed with the Securities and
Exchange Commission on March 15, 2019. In addition, the forward-looking
statements included in this press release represent our views as of May
2, 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