Tetraphase Pharmaceuticals Completes Enrollment of IGNITE3 Phase 3 Clinical Trial of Eravacycline in Complicated Urinary Trac...
September 11 2017 - 7:00AM
- Top-line Data Expected in 1Q 2018 -
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 IGNITE3, its ongoing phase 3
clinical trial evaluating the efficacy and safety of once-daily
intravenous (IV) eravacycline compared to ertapenem in complicated
urinary tract infections (cUTI). The Company expects to
report top-line data from this trial in the first quarter of 2018.
“We have now completed enrollment of approximately 1,200
patients in IGNITE3, well ahead of schedule, and we expect top-line
data from IGNITE3 to be available during the first quarter of
2018,” said Guy Macdonald, President and CEO of Tetraphase.
“In parallel, we are working to prepare a New Drug
Application (NDA) for twice-daily IV eravacycline in complicated
intra-abdominal infections, which will be comprised of data from
the successfully completed phase 3 IGNITE1 and IGNITE4 clinical
trials. Assuming a positive outcome from IGNITE3 and approval
of IV eravacycline for the treatment of cIAI, we plan to file a
supplemental NDA (sNDA) for IV eravacycline as a new treatment for
patients with cUTI.”
Mr. Macdonald added, “With high rates of quinolone resistance in
hospitals in the U.S. and around the world, we believe a once-daily
IV therapy for cUTI could be an important new treatment option for
patients who are eligible for completing their course of
antibiotics in an outpatient setting.”
About IGNITE3IGNITE3 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 enrolled approximately 1,200 patients
who were randomized 1:1 to receive eravacycline or ertapenem for a
minimum of 5 days, and then were eligible for transition to an
appropriate 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 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. Eravacycline is in 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 1,500 patients and in two
completed phase 3 trials in cIAI. 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 is serving as the basis of the Marketing Authorization
Application for IV eravacycline for the treatment of patients with
cIAI now under review by the European Medicines Agency. In IGNITE4,
a second phase 3 clinical trial in patients with cIAI, twice-daily
IV eravacycline met the primary endpoint by demonstrating
statistical non-inferiority of clinical response compared to
meropenem, was well tolerated, and achieved high cure rates.
The Company plans to use the results from IGNITE1 and IGNITE4 to
support an NDA submission for IV eravacycline in cIAI in the first
quarter of 2018. 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
from IGNITE3 and approval of IV eravacycline for the treatment of
cIAI, 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 a phase 3 clinical program, 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-Q, filed with
the Securities and Exchange Commission on August 2, 2017. In
addition, the forward-looking statements included in this press
release represent our views as of September 11, 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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