Tetraphase Pharmaceuticals Doses First Patient in IGNITE4 Phase 3 Clinical Trial of Eravacycline in cIAI
October 14 2016 - 07:30AM
Top-line IGNITE4 Data Expected in 4Q 2017
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today
announced dosing of the first patient in IGNITE4, the Company’s
phase 3 clinical trial evaluating the efficacy and safety of
intravenous (IV) eravacycline compared to meropenem in complicated
intra-abdominal infections (cIAI). 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.
“Patient dosing is now underway in IGNITE4, and we continue to
expect top-line data in the fourth quarter of 2017. If successful,
these data, along with data from our positive IGNITE1 study in
cIAI, will support a new drug application (NDA) submission for IV
eravacycline in cIAI,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “Antibiotic resistance
continues to be a growing public health threat and this critical
issue is achieving attention on a global scale, most recently as an
area of focus at the United Nations General Assembly.
Tetraphase is committed to being part of the solution by working to
develop new antibiotics to treat these serious infections.”
IGNITE4 is a phase 3 randomized, double-blind, double-dummy,
multicenter, prospective study that is designed to assess the
efficacy, safety and pharmacokinetics of twice-daily eravacycline
(1.0 mg/kg every 12 hours) compared with meropenem (1g every 8
hours) for the treatment of cIAI. The study is expected to
enroll approximately 450 adult patients at 75 centers worldwide.
The primary endpoint of IGNITE4 is clinical response at the
test-of-cure (TOC) visit, which occurs 25 to 31 days after the
initial dose of the study drug. The primary efficacy analysis
will be conducted using a 12.5% non-inferiority margin in the
microbiological intent-to-treat (micro-ITT) population.
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 tested in over 1,300 patients and has been tested 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 inferiority of clinical response compared to
ertapenem, was well tolerated, and achieved high cure rates in
patients with Gram-negative pathogens, including resistant
isolates. 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. The
Company plans to initiate IGNITE3, an additional phase 3 trial
evaluating once-daily IV eravacycline in patients with complicated
cUTI. Assuming a positive outcome, the Company plans to use
the results from IGNITE3 to support a supplemental NDA (sNDA)
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
interim 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 August 4, 2016. In addition, the
forward-looking statements included in this press release represent
our views as of October 14, 2016. 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
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
mikebeyer@sambrown.com
Argot Partners
Maeve Conneighton
212-600-1902
maeve@argotpartners.com
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