Tetraphase Pharmaceuticals Doses First Patient in IGNITE3 Phase 3 Clinical Trial of Once-daily IV Eravacycline in cUTI
January 17 2017 - 8:00AM
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced
dosing of the first patient in IGNITE3, the Company’s phase 3
clinical trial evaluating the efficacy and safety of once-daily
intravenous (IV) eravacycline compared to ertapenem in complicated
urinary tract infections (cUTI). Eravacycline is a novel
antibiotic candidate with potent activity against
multidrug-resistant (MDR) pathogens, including carbapenem-resistant
Enterobacteriaceae (CRE), Acinetobacter baumannii, and
colistin-resistant bacteria carrying the mcr-1 gene, that is being
developed for the treatment of serious and life-threatening
bacterial infections.
“We are pleased to have initiated patient enrollment for IGNITE3
in cUTI, the second indication for which eravacycline is being
evaluated,” said Guy Macdonald, President and Chief Executive
Officer of Tetraphase. “Assuming a positive outcome from this
study, these data are expected to support a supplemental New Drug
Application (sNDA) submission for IV eravacycline in cUTI. We
remain on track to report top-line results from the ongoing IGNITE4
study in complicated intra-abdominal infections during the fourth
quarter of 2017, followed by an NDA submission for IV eravacycline
in cIAI.”
IGNITE3 is a randomized, multi-center, double-blind, phase 3
clinical trial evaluating the efficacy and safety of once-daily IV
eravacycline (1.5mg/kg every 24 hours) compared to ertapenem (1g
every 24 hours) for the treatment of cUTI. IGNITE3 is expected to
enroll approximately 1,000 patients who will be randomized 1:1 to
receive eravacycline or ertapenem for a minimum of 5 days, and will
then be eligible for transition to an approved oral agent.
The co-primary endpoints of responder rate (a combination of
clinical cure and microbiological success) in the microbiological
intent-to-treat (micro-ITT) population at the end-of-IV treatment
visit and at the test-of-cure visit (Day 5-10 post therapy) will be
evaluated using a 10% non-inferiority margin.
About EravacyclineEravacycline is a novel,
fully-synthetic tetracycline antibiotic being developed for the
treatment of serious infections, including those caused by
multidrug-resistant (MDR) pathogens that have been highlighted as
urgent public health threats by both the World Health Organization
and the U.S. Centers for Disease Control (CDC). Eravacycline
is Tetraphase’s lead product candidate in phase 3 clinical
development for the treatment of complicated intra-abdominal
infections (cIAI) and complicated urinary tract infections
(cUTI).
Eravacycline is currently being investigated in the Company’s
phase 3 IGNITE (Investigating
Gram-negative
Infections Treated with
Eravacycline) program. To date, eravacycline
has been administered to over 1,300 patients and has been evaluated
in two completed phase 3 trials – IGNITE1 in patients with cIAI and
IGNITE2 in patients with cUTI. In IGNITE1, twice-daily IV
eravacycline met the primary endpoint by demonstrating statistical
non-inferiority of clinical response compared to ertapenem, was
well tolerated, and achieved high cure rates in patients with
Gram-negative pathogens, including resistant isolates. The
company plans to use the data from the IGNITE1 clinical trial
to support a Marketing Authorization Application submission to
the European Medicines Agency in the second half of 2017 for IV
eravacycline for the treatment of patients with cIAI. Tetraphase is
currently evaluating eravacycline in a second phase 3 clinical
trial in patients with cIAI (IGNITE4) comparing twice-daily IV
eravacycline to meropenem. Assuming a positive outcome in
IGNITE4, the Company plans to use the results from IGNITE1 and
IGNITE4 to support an NDA submission for IV eravacycline for the
treatment of patients with cIAI. Tetraphase is also currently
conducting IGNITE3, an additional phase 3 trial evaluating
once-daily IV eravacycline in patients with cUTI and, assuming a
positive outcome, the Company plans to use the results from IGNITE3
to support a supplemental NDA submission for eravacycline in
cUTI. In parallel, Tetraphase is continuing its efforts to
develop an oral dose formulation of eravacycline. A phase 1
clinical program is ongoing which is designed to evaluate and
optimize the oral dosing regimen for eravacycline.
About Tetraphase Pharmaceuticals,
Inc.Tetraphase is a clinical-stage 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 (MDR)
bacteria highlighted as urgent public health threats by the CDC.
Tetraphase has created more than 3,000 novel tetracycline analogs
using its proprietary technology platform. Tetraphase's
pipeline includes three antibiotic clinical candidates:
eravacycline, which is in phase 3 clinical trials, and 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 results obtained in early or
previous clinical trials will be indicative of results
obtained in future clinical trials; whether eravacycline or any
other clinical candidate will advance through the clinical trial
process on a timely basis; whether the results of the Company’s
trials will warrant regulatory submission and regulatory approval
from the United States Food and Drug Administration or equivalent
foreign regulatory agencies; whether, if any clinical candidate
obtains approval, it will be successfully distributed and marketed;
and other factors discussed in the “Risk Factors” section of our
quarterly report on Form 10-Q, filed with the Securities and
Exchange Commission on November 3, 2016. In addition, the
forward-looking statements included in this press release represent
our views as of January 17, 2017. 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 Contacts:
Tetraphase Pharmaceuticals
Teri Dahlman
617-600-7040
tdahlman@tphase.com
Argot Partners
Maeve Conneighton
212-600-1902
maeve@argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
mikebeyer@sambrown.com
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