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 SubgroupsDate and
time: Thursday, May 9 from 5:00 – 6:30 p.m. ETLocation:
Grand Ballroom CDEPoster number: 75 E
Poster title: Efficacy of Eravacycline in Obese Patients:
Pooled Analysis of IGNITE1 and IGNITE4Date and time:
Thursday, May 9 from 5:00 – 6:30 p.m. ETLocation: Grand
Ballroom CDEPoster 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 EravacyclineDate and time: Thursday, May 9 from 5:00 –
6:30 p.m. ETLocation: Grand Ballroom CDEPoster
number: 73 E
Poster title: Micro Efficacy of Eravacycline Against
Enterobacteriaceae and Acinetobacter, Including MDR Isolates: A
Pooled Analysis from IGNITE1 and IGNITE4Date and time:
Thursday, May 9 from 5:00 – 6:30 p.m. ETLocation: Grand
Ballroom CDEPoster 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. ETLocation: Grand Ballroom
CDEPoster 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 UsageXERAVA 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 UseXERAVA is not indicated for the treatment of
complicated urinary tract infections (cUTI).
UsageTo 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 InformationXERAVA 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.
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Media and Investor Contact:Jennifer
Vierajviera@tphase.com617-600-7040
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