Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage
biopharmaceutical company developing novel antibiotics to treat
life-threatening multidrug-resistant (MDR) infections, today
announced the presentation of data at IDWeek 2017 from the first
study of a recently completed phase 1 program designed to optimize
drug exposure of oral eravacycline in an IV-to-oral dosing
regimen. These results, along with data from subsequent trials in
this phase 1 program, have allowed for the identification of an
optimized IV-to-oral dosing regimen using the current oral
formulation which the company plans to advance into a phase 2
clinical trial in patients with complicated urinary tract
infections (cUTI). This study is anticipated to begin in the first
half of 2018.
Eravacycline is a novel, fully-synthetic fluorocycline
antibiotic being developed for the treatment of serious infections,
including those caused by MDR pathogens. The IV eravacycline
program includes two successfully completed phase 3 clinical trials
in complicated intra-abdominal infections and an ongoing phase 3
clinical trial in cUTI. Separately, the oral eravacycline
development program is ongoing and is designed to optimize and
evaluate an IV-to-oral transition therapy of eravacycline.
“We are encouraged by the clinical data in healthy volunteers we
have recently seen in the phase 1 oral eravacycline development
program and are eager to initiate the next step of evaluating the
optimized IV-to-oral dosing regimen in a patient population,” said
Guy Macdonald, President and Chief Executive Officer of Tetraphase.
“In addition to establishing an oral dosing regimen, this phase 1
program has also confirmed that drug exposures and urine
concentrations achieved with IV eravacycline are within the
expected therapeutic range and support the efficacy of once-daily
IV eravacycline in cUTI, which we are evaluating in the ongoing
phase 3 IGNITE3 study. We look forward to topline data for IGNITE3
in the first quarter of 2018.”
Patrick Horn, Chief Medical Officer of Tetraphase added, “Data
from this phase 1 study presented at IDWeek confirm that the timing
of oral dosing relative to meals drove the lower than expected drug
exposures seen with the oral dosing regimen in IGNITE2, our first
phase 3 IV-to-oral study in cUTI. Subsequent studies in this phase
1 oral program then evaluated different doses of eravacycline and
varied meal time/dosing schedules. Results confirmed that
increasing the interval between meals and dosing and administering
a 250 mg oral dose of eravacycline produces drug exposures that we
believe will be therapeutic in cUTI. With this optimized IV-to-oral
dosing regimen, drug exposures achieved with the oral dose were 81%
of those achieved with IV dosing, approximately double the exposure
observed with the dosing regimen used in IGNITE2.”
Dr. Horn continued, “We have also seen promising data in phase 1
clinical trials using a new oral eravacycline formulation and we
will continue phase 1 development of this new formulation in
parallel, as it could represent a future life-cycle option for oral
eravacycline.”
Study Design of the Phase 1 trial presented at
IDWeekThis study evaluated the IV-to-oral dosing regimen
and meal schedule that was used in the phase 3 IGNITE2 study.
The objective was to assess plasma and urine levels achieved with
that dosing regimen and compare these levels to those achieved
using the same dosing regimen under fasted conditions. Sixteen
healthy volunteers were enrolled in a cross-over study. Subjects
were randomized 1:1 into either the fasted/fed or fed/fasted
eravacycline treatment sequences. The dosing regimen was 1.5 mg/kg
IV once daily on Days 1-3 and 200 mg oral twice daily, starting 12
hours after the Day 3 IV dose and continuing through Day 7.
Plasma and urine samples for pharmacokinetic analysis were
collected on Days 1, 3 and 7.
Study Results of the Phase 1 trial presented at
IDWeekIn the fasted period, drug exposures on Day 7 were
65% of those achieved after the first IV dose, and both drug
exposure and urine concentrations were in the expected therapeutic
range. In the fed period, drug exposures on Day 7 were 39% of
those achieved after the first IV dose, and both the drug exposure
and urine concentrations were below the expected therapeutic range.
The most commonly reported treatment-emergent adverse events
(TEAEs) were nausea, vomiting, diarrhea and infusion site erythema,
all of which were mild to moderate and occurred at rates similar to
those observed in previous phase 1 studies with eravacycline. There
were no discontinuations due to TEAEs.
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 in
patients with Gram-negative pathogens, including resistant
isolates. 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 clinical program is ongoing which is designed to
optimize and evaluate the oral dosing regimen for eravacycline as
part of an IV-to-oral transition therapy.
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 development, 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 eravacycline 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 October 4, 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
PharmaceuticalsTeri Dahlman617-600-7040tdahlman@tphase.com
Argot PartnersMaeve
Conneighton206.899.4940maeve@argotpartners.com
Media Contact:Sam Brown Inc.Mike
Beyer312-961-2502Mikebeyer@sambrown.com
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