Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by Euro...
August 17 2017 - 08:30AM
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage
biopharmaceutical company developing novel antibiotics to treat
life-threatening multidrug- resistant (MDR) infections, today
announced that the Marketing Authorization Application (MAA) for IV
eravacycline for the treatment of complicated intra-abdominal
infections (cIAI) has been submitted and was validated by the
European Medicines Agency (EMA). Eravacycline is a novel,
fully-synthetic fluorocycline antibiotic being developed for the
treatment of serious infections, including those caused by
multidrug-resistant (MDR) pathogens. The MAA filing is based on
data from the phase 3 IGNITE1 clinical trial in which eravacycline
was well tolerated and demonstrated statistical non-inferiority to
ertapenem using the primary endpoint of clinical response at the
test-of-cure (TOC) visit.
“The MAA filing represents a significant milestone for
Tetraphase as it is our first regulatory application for marketing
authorization and a major step toward making eravacycline available
as a new antibiotic treatment option for patients with serious
hospital infections,” said Guy Macdonald, President and Chief
Executive Officer of Tetraphase. “I am proud of the dedicated team
at Tetraphase who made this happen and who support our
commitment to develop novel antibiotics to treat drug-resistant
infections. We look forward to working with the EMA during their
review of this application and to focusing on the submission of the
New Drug Application to the U.S. Food and Drug Administration in
the first quarter of 2018.”
About Eravacycline
Eravacycline 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 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 1,500 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 MAA for IV eravacycline for the treatment of patients
with cIAI now under review by the EMA. 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. 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 Complicated Intra-abdominal Infections
(cIAI)Intra-abdominal infection (IAI) is a common problem in
clinical practice and comprises a wide variety of disease
processes. IAI is classified as uncomplicated or complicated based
on the extent of the infection. Complicated intra-abdominal
infection extends beyond the source organ into the peritoneal space
(the space between the two membranes that separate the organs in
the abdominal cavity from the abdominal wall) as a result of
perforation or other damage to the gastrointestinal tract. cIAI
diagnoses include intra-abdominal abscess, stomach or intestinal
perforation, peritonitis, appendicitis, cholecystitis, or
diverticulitis. Different bacterial pathogens are responsible for
cIAI, including Gram-negative aerobic bacteria, Gram-positive
bacteria, and anaerobic bacteria, and there are also mixed
infections. IAI is an important cause of morbidity and mortality
and is the second most common cause of infectious mortality in the
intensive care unit. Early detection, containment and appropriate
antimicrobial treatment are essential to the successful treatment
of IAI. This is even more critical with increasing rates of
infections caused by drug-resistant bacteria, which limit the
effectiveness of currently available antibiotics.
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 Statements
Any 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
eravacycline or any other 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 August 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
206.899.4940
maeve@argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer@sambrown.com
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