̶ IV Eravacycline Achieves Primary
Endpoint in Second of Two Pivotal Trials in cIAI ̶
Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage
biopharmaceutical company developing novel antibiotics to treat
life-threatening multidrug-resistant (MDR) infections, today
announced positive top-line results from IGNITE4, the Company's
phase 3 clinical trial evaluating the efficacy and safety of
twice-daily intravenous (IV) eravacycline compared to meropenem for
the treatment of patients with complicated intra-abdominal
infections (cIAI). The results of IGNITE4, which enrolled 500
patients, demonstrated statistical non-inferiority of eravacycline
to meropenem for the primary efficacy endpoint of clinical response
at the test-of-cure (TOC) visit.
“Complicated intra-abdominal infections are increasingly caused
by resistant pathogens and appropriate antibiotic therapy is
critical to successful outcomes,” commented Joseph Solomkin, M.D.,
Professor Emeritus in the Department of Surgery at the University
of Cincinnati College of Medicine and advisor to the Company.
“Collectively, the data from the IGNITE program in cIAI
versus two widely-used comparators, ertapenem and meropenem,
provides compelling evidence for IV eravacycline monotherapy and
its potential to be a valuable new addition to the limited toolkit
currently available to treat serious, and often life-threatening
MDR infections.”
Top-line Results from Phase 3 IGNITE4 Clinical Trial in
Patients with cIAI: Summary of FDA and EMA Primary Efficacy
EndpointsA summary of the IGNITE4 efficacy data is
outlined in the following table and described below:
|
Eravacyclinen/N (%) |
Meropenemn/N (%) |
95% Confidence Interval (CI) |
Microbiological intent-to-treat (micro-ITT) population; 12.5%
non-inferiority margin (FDA) |
177/195 (90.8%) |
187/205 (91.2%) |
-6.3, 5.3 |
Modified intent-to-treat (MITT); 12.5% non-inferiority margin
(EMA) |
231/250 (92.4%) |
228/249 (91.6%) |
-4.1, 5.8 |
Clinically evaluable (CE); 12.5% non-inferiority margin (EMA) |
218/225 (96.9%) |
222/231 (96.1%) |
2.9, 4.5 |
Eravacycline achieved high clinical cure rates in patients with
complicated intra-abdominal infections, comparable to patients in
the meropenem group. The primary efficacy analysis under the U.S.
Food and Drug Administration (FDA) guidance was conducted using a
12.5% non-inferiority margin in the micro-ITT population.
Clinical cure rates in the micro-ITT population were 90.8%
and 91.2% for eravacycline (n=195) and meropenem (n=205),
respectively (95% CI: -6.3%,5.3%). Under the EMA guidance,
the primary analysis was conducted using a 12.5% non-inferiority
margin of the modified intent-to-treat (MITT) and clinically
evaluable (CE) patient populations. Clinical cure rates in
the MITT population were 92.4% and 91.6% for eravacycline (n=250)
and meropenem (n=249), respectively (95% CI: -4.1%,5.8%).
Clinical cure rates in the CE population were 96.9% and 96.1%
for eravacycline (n=225) and meropenem (n=231), respectively (95%
CI: -2.9%,4.5%). Eravacycline met the primary efficacy endpoints
according to the FDA and EMA guidelines. The secondary analyses
were consistent with, and supportive of, the primary outcome.
There were no treatment-related serious adverse events (SAEs) in
the trial. Treatment-emergent adverse event (TEAEs) rates
were similar in both treatment groups. The most commonly reported
drug-related adverse events (AEs) for eravacycline were infusion
site reactions, nausea and vomiting, each occurring at a rate of
less than 5%. The AE profile for IV eravacycline in IGNITE4
was consistent with that seen in the previously completed phase 3
IGNITE1 and phase 2 clinical trials in cIAI.
The spectrum of pathogens in this trial was similar to that seen
in previously completed clinical trials in this patient population.
The most common Gram-negative pathogens in the study included
Escherichia coli, Klebsiella pneumonia, Pseudomonas and
Bacteroides.
Tetraphase plans to submit a New Drug Application (NDA), which
will be supported by data from the IGNITE1 and IGNITE4 clinical
trials, to the FDA in the first quarter of 2018. The Company
also remains on track to submit a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) during the
third quarter of 2017. In addition, Tetraphase plans to
submit detailed results from the phase 3 IGNITE4 clinical trial for
presentation at a future scientific meeting.
“The successful outcome of this second of two pivotal phase 3
trials investigating twice-daily IV eravacycline for the treatment
of cIAI is a critical achievement for Tetraphase as we continue
preparations to submit our first NDA to the FDA for IV
eravacycline, which we expect in the first quarter of 2018,” said
Guy Macdonald, President and CEO of Tetraphase. “I would like to
express my sincere gratitude to all of the patients and physicians
that participated in the IGNITE4 and IGNITE1 studies. We believe
that eravacycline has the potential to play a key role in the
treatment of serious hospital infections, and we are another step
closer to realizing that goal.”
Mr. Macdonald continued, “In the coming months, along with
execution of the U.S. and European regulatory submissions for
eravacycline in cIAI, we will also continue to focus on completing
the ongoing phase 3 IGNITE3 study for once-daily IV eravacycline in
complicated urinary tract infections (cUTI). We are pleased to
share that IGNITE3 is enrolling more rapidly than expected and we
now expect to complete enrollment early in the fourth quarter of
2017.”
In parallel with the clinical trials investigating IV
eravacycline, Tetraphase is also developing an oral formulation of
eravacycline. The Company has completed certain phase 1
clinical studies designed to identify optimal dosing regimen and
exposure. Further phase 1 clinical testing is currently
ongoing and the company expects to provide an update with top-line
findings and potential next steps during the third quarter of
2017.
Conference Call InformationTetraphase will host
a conference call today at 5:00 pm Eastern Time to discuss the
top-line data from the phase 3 IGNITE4 clinical trial. The
call can be accessed by dialing (844) 831-4023 (U.S. and Canada) or
(731) 256-5215 (international). To access the live audio
webcast, or the subsequent archived recording, visit the "Investors
Relations — Events & Presentations" section of the Tetraphase
website at www.tphase.com. The webcast will be recorded and
available for replay on the Tetraphase website for 30 days
following the call.
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 intravenous eravacycline (1.0 mg/kg every 12 hours)
compared with meropenem (1g every 8 hours) for the treatment of
cIAI. The study enrolled 500 adult patients at 66 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 was conducted using a 12.5% non-inferiority margin in the
microbiological intent-to-treat (micro-ITT) population.
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 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 May
8, 2017. In addition, the forward-looking statements included in
this press release represent our views as of July 25, 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
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
Historical Stock Chart
From Apr 2024 to May 2024
Tetraphase Pharmaceuticals (NASDAQ:TTPH)
Historical Stock Chart
From May 2023 to May 2024