Tetraphase Pharmaceuticals Completes Enrollment of IGNITE4 Phase 3 Clinical Trial of Eravacycline in Complicated Intra-abdomi...
April 03 2017 - 8:00AM
Accelerated Timelines for Both Top-line
IGNITE4 Eravacycline Data and MAA filing in Europe; Both Now
Expected in 3Q 2017
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage
biopharmaceutical company developing novel antibiotics to treat
life-threatening multidrug-resistant (MDR) infections, today
announced completion of enrollment in IGNITE4, its ongoing phase 3
clinical trial evaluating the efficacy and safety of intravenous
(IV) eravacycline compared to meropenem in complicated
intra-abdominal infections (cIAI). The Company expects to
report top-line data from this trial in the third quarter of 2017.
“Completing IGNITE4 enrollment ahead of schedule speaks to the
strong investigator support for this study, along with the
dedication and hard work by our internal team and collaborating
clinical research organization,” said Guy Macdonald, President and
CEO of Tetraphase. “Following the protocol-specified
follow-up period, requisite data validation and subsequent database
lock activities, we now expect top-line data from IGNITE4 to be
available during the third quarter of 2017. Assuming a
positive outcome, we believe the data from IGNITE4, along with data
from the successfully completed IGNITE1 trial, will form the basis
of a U.S. NDA filing for IV eravacycline in cIAI.”
Tetraphase also updated its guidance today regarding the planned
submission of a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for IV eravacycline for the
treatment of cIAI which will be supported by data from the IGNITE1
trial. The Company expects to file the MAA during the third quarter
of 2017.
“With respect to eravacycline in Europe, we are updating our
prior guidance to reflect submission of a MAA to the EMA, the first
regulatory filing for IV eravacycline as a potential new treatment
for cIAI, also during the third quarter of 2017. We are well
positioned to execute on these critical milestones with the goal of
bringing eravacycline to the physicians and patients who need it,”
Mr. Macdonald concluded.
About IGNITE4IGNITE4 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 fluorocycline 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
has demonstrated potent activity against multidrug-resistant (MDR)
pathogens, including carbapenem-resistant enterobacteriaceae (CRE),
Acinetobacter baumannii, and colistin-resistant bacteria carrying
the mcr-1 gene, and is being developed for the treatment of serious
and life-threatening bacterial infections. Eravacycline is 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 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 IGNITE1 data will support an MAA
submission to the EMA 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 in 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 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;
whether the results of the Company's development efforts will
warrant regulatory submission and whether any such submissions will
receive 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-K, filed with
the Securities and Exchange Commission on March 13, 2017. In
addition, the forward-looking statements included in this press
release represent our views as of April 3, 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
206.899.4940
maeve@argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.com
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