XERAVA Demonstrated Efficacy in Treating
Secondary Bacteremia in Patients with Complicated Intra-Abdominal
Infections in Post-Hoc Analysis of Phase 3 Clinical Trials
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a
biopharmaceutical company focused on developing and commercializing
novel antibiotics to treat life-threatening multidrug-resistant
(MDR) infections, announced data from a pooled analysis of two
Phase 3 studies of XERAVA in complicated intra-abdominal infection
(cIAI) and a Phase 1 multiple-ascending dose study for its pipeline
candidate TP-6076. These data were presented at the Infectious
Disease Society of America’s (IDSA) Infectious Disease Week
(IDWeek) 2018, held October 3-7 in San Francisco.
“The data presented at IDWeek demonstrate high clinical cure
rates and microbiological eradication with XERAVA among patients
with cIAI and concurrent bacteremia,” said Guy Macdonald, President
and Chief Executive Officer of Tetraphase. “These data confirm the
efficacy of XERAVA in a subgroup of cIAI patients who may be at
higher risk for poor outcomes, and this new analysis comes at an
exciting time as we make final preparations for the commercial
launch of XERAVA in the coming weeks.”
Mr. Macdonald added, “We are also encouraged by the positive
safety, tolerability and pharmacokinetic data from the
multiple-ascending dose Phase 1 study evaluating a seven-day dosing
regimen for intravenous (IV) TP-6076. We plan to advance TP-6076 to
a bronchopulmonary disposition study beginning in the first quarter
of 2019 to confirm appropriate therapeutic levels of TP-6076 in the
lungs to treat infections caused by Acinetobacter baumannii and
other MDR pathogens. In previously completed in vitro testing,
TP-6076 MIC90 values were as much as 64-fold lower than those for
tigecycline against MDR Gram-negative pathogens, including
Acinetobacter baumannii, suggesting that TP-6076 could be a potent
treatment for these difficult-to-treat bacteria. We are
enthusiastic about the potential for TP-6076 and the future of this
program.”
Efficacy of Eravacycline in Secondary Bacteremia: A
Post-Hoc Analysis of Two Phase 3 Studies of Complicated
Intra-Abdominal Infections
XERAVA was evaluated for the treatment of cIAI in two Phase 3
clinical trials. The objective of this post-hoc analysis was to
evaluate microbiological response at the test of cure (TOC) visit
in patients with baseline bacteremia who received XERAVA versus
comparators ertapenem and meropenem.
Pooled data from the Phase 3 studies were analyzed. All patients
enrolled were randomized (1:1) to receive XERAVA 1 mg/kg IV every
12 hours or ertapenem 1 g IV every 24 hours, (IGNITE1 study) or
meropenem 1g IV every 8 hours, (IGNITE4 study) for 4-14 days. Blood
and intra-abdominal samples were collected from all patients.
Clinical outcome at the TOC visit (28 days after randomization) in
the microbiological-intention to treat population (micro-ITT) was
the primary efficacy endpoint.
Among the 415 patients treated with XERAVA and 431 patients
treated with comparators, 39 and 40 patients, respectively, had
concurrent bacteremia. For patients with concurrent bacteremia
caused by Gram-positive bacteria or anaerobes, the microbiological
eradication was 100% for those treated with XERAVA as well as for
those treated with comparators. Patients with bacteremia due to
Gram-negative pathogens, including Escherichia coli, achieved 93%
microbiological eradication when treated with XERAVA or a
comparator.
Safety, Tolerability and Pharmacokinetics of Multiple
Doses of TP-6076, a Novel, Fully Synthetic
Tetracycline
This poster presentation highlighted data from a Phase 1
randomized, placebo-controlled, double-blind,
multiple-ascending-dose study evaluating the safety, tolerability
and pharmacokinetics of TP-6076 conducted at a single center in 40
healthy volunteers. Cohorts of eight subjects each were randomized
6:2 to receive daily doses ranging from 6.0 mg to 40 mg, or
placebo.
In this study, TP-6076 was generally well tolerated, and there
were no serious or severe adverse events. There were no clinically
significant safety findings in any laboratory assessments, vital
signs, electrocardiographs, or physical examinations. The most
frequently reported adverse events were gastrointestinal events,
including nausea and vomiting, and localized infusion-site
reactions.
TP-6076 is a novel, synthetic, fluorocycline antibiotic
candidate being developed for the treatment of serious and
life-threatening bacterial infections, including those caused by
pathogens otherwise resistant to current treatment options. It has
demonstrated potent in vitro activity against multidrug-resistant
bacteria including carbapenem-resistant Enterobacteriaceae and
carbapenem-resistant Acinetobacter baumannii.
About XERAVA™
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 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 or to tetracycline-class
antibacterial drugs. 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 is a biopharmaceutical company using its
proprietary chemistry technology to create novel antibiotics for
serious and life-threatening bacterial infections, including those
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 XERAVA
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. Please
visit www.tphase.com for more company information.
Forward-Looking StatementsAny statements in
this press release about our future expectations, plans and
prospects, including statements regarding our strategy, future
operations, prospects, plans and objectives, 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 eravacycline will be
successfully distributed and marketed; whether results obtained in
previous clinical trials will be indicative of results obtained in
future clinical trials; whether any clinical candidate will advance
through the clinical trial process on a timely basis or at all and
other regulatory and commercial risk factors discussed in the "Risk
Factors" section of our quarterly report on Form 10-Q for the
period ended June 30, 2018, filed with the Securities and Exchange
Commission on August 2, 2018. In addition, the forward-looking
statements included in this press release represent our views as of
October 8, 2018. 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.
Investor and Media Contacts:Tetraphase
PharmaceuticalsJennifer Viera617-600-7040jviera@tphase.com
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