Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency
(Thomson Reuters ONE) -
WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- 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(at)tphase.com
Argot Partners
Maeve Conneighton
206.899.4940
maeve(at)argotpartners.com
Media Contact:
Sam Brown Inc.
Mike Beyer
312-961-2502
Mikebeyer(at)sambrown.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Tetraphase Pharmaceuticals via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 17.08.2017 - 14:30 Uhr
Sprache: Deutsch
News-ID 556946
Anzahl Zeichen: 9150
contact information:
Town:
Watertown
Kategorie:
Business News
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