Entasis Therapeutics Initiates Global Phase 3 Pivotal Trial of ETX2514SUL for Patients with Carbapenem-Resistant Acinetobacte...
April 04 2019 - 8:00AM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company developing novel antibacterials to treat
serious drug-resistant infections, today announced the initiation
of the ATTACK (
Acinetobacter
Treatment
Trial
Against
Colistin) Phase 3 pivotal
clinical trial to evaluate ETX2514SUL, a fixed-dose combination of
its broad-spectrum β-lactamase inhibitor ETX2514 with sulbactam,
for the treatment of patients with pneumonia and bloodstream
infections caused by carbapenem-resistant Acinetobacter baumannii.
A. baumannii is a Gram-negative bacterium that
causes severe infections and is associated with high mortality,
increasing rates of antibiotic resistance and growing significance
as a hospital-acquired infection due to limited treatment options.
Outbreaks of A. baumannii typically occur in intensive care units
and healthcare settings with seriously ill patients, and can either
cause or contribute to death. Resistance to carbapenems, a class of
antibiotics commonly used for the treatment of severe bacterial
infections, has grown substantially amongst Acinetobacter in the
last decade, resulting in a significant unmet medical need.
“There are currently very limited antibiotic
choices for the treatment of multidrug-resistant A. baumannii
infections, and mortality rates approach 50%,” said Robin Isaacs,
MD, Chief Medical Officer. “More than 60% of A. baumannii strains
tested in the United States in 2016 were resistant to carbapenems,
and in some European and Asian countries carbapenem resistance
surpasses 80%. ETX2514SUL offers a precision, pathogen-targeted,
approach to the treatment of A. baumannii. We look forward to
enrolling patients in our ATTACK trial which will evaluate
ETX2514SUL’s efficacy and safety in the treatment of drug-resistant
A. baumannii infections.”
ATTACK is a global, two-part Phase 3 clinical
trial that will enroll a total of 300 patients from 18 countries.
The Company believes this single Phase 3 trial could be sufficient
to support the filing of a new drug application with regulatory
authorities in both the U.S. and Europe. Subject to necessary
regulatory approvals, the clinical trial will also leverage the
Company’s partnership with Zai Lab for patient enrollment in China,
and potentially provide early access for patients in Asia-Pacific
countries. The trial will also incorporate the BioFire® FilmArray®
Pneumonia Panel to optimize and accelerate patient enrollment. For
more information about the ATTACK trial, please visit
www.clinicaltrials.gov (NCT03894046).
"We are excited to initiate our global ATTACK
clinical trial with the ultimate goal of obtaining regulatory
approval in the U.S. and other countries,” said Manos Perros, Chief
Executive Officer, Entasis Therapeutics. “It is the culmination of
extensive preclinical development and multiple Phase 1 and 2
clinical trials, which have shown that ETX2514SUL has great
potential for the treatment of patients with carbapenem-resistant
A. baumannii infections. We are fully funded through this study and
look forward to reporting top-line data in the second half of
2020.”
The initiation of ATTACK follows the
End-of-Phase-2 meeting with the U.S. Food and Drug Administration
(FDA). ETX2514SUL has been designated a Qualified Infectious
Disease Product (QIDP) by the U.S. FDA and granted Fast Track
designation.
About ETX2514ETX2514 is a
novel, broad-spectrum inhibitor of class A, C, and D β-lactamases.
ETX2514 restores the in vitro activity of multiple β-lactams
against Gram-negative, multidrug-resistant (MDR) pathogens. Entasis
Therapeutics is initially developing ETX2514SUL, the combination of
ETX2514 and sulbactam, for the treatment of severe A. baumannii
infections. Sulbactam is a generic β-lactam which has intrinsic
antibacterial activity against A. baumannii but suffers from
widespread β-lactamase-mediated resistance. In preclinical studies,
ETX2514 restored sulbactam antibacterial activity against A.
baumannii. ETX2514 has completed single- and multi-ascending dose
Phase 1 trials and a Phase 2 trial, in combination with sulbactam,
in complicated urinary tract infections.
About EntasisEntasis is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of novel antibacterial products
to treat serious infections caused by multidrug-resistant
Gram-negative bacteria. Entasis’ targeted-design platform has
produced a pipeline of product candidates, including ETX2514SUL
(targeting A. baumannii infections), zoliflodacin (targeting
Neisseria gonorrhoeae), and ETX0282CPDP (targeting
Enterobacteriaceae infections). Entasis is also using its platform
to develop a novel class of antibiotics, non-β-lactam inhibitors of
the penicillin-binding proteins (NBPs) (targeting Gram-negative
infections). For more information, visit www.entasistx.com.
Entasis Forward-looking
Statements This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect," "plan,"
"anticipate," "estimate," "intend" and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on Entasis’
expectations and assumptions as of the date of this press release.
Each of these forward-looking statements involves risks and
uncertainties. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in
this press release include statements about (i) the timing of the
initiation, progress and scope of the Phase 3 clinical trial of
ETX2514SUL; (ii) the timing of the availability of data; (iii)
design of the Phase 3 clinical trial of ETX2514SUL, including plans
to incorporate BIOFIRE Instruments and Pneumonia Panels into this
trial and their ability to optimize and accelerate patient
enrollment; (iv) the success of the Phase 3 clinical trial of
ETX2514SUL; (v) the sufficiency of the single trial to support the
filing of an NDA with the FDA; and (vi) potential clinical benefits
of ETX2514SUL. Many factors may cause differences between current
expectations and actual results, including unexpected safety or
efficacy data observed during non-clinical or clinical studies,
clinical site activation rates or clinical trial enrollment rates
that are lower than expected and changes in expected or existing
competition. Except as required by law, Entasis assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Entasis Company Contact
Kyle Dow Entasis Therapeutics (781) 810-0114
kyle.dow@entasistx.com
Investor Relations ContactLee RothThe Ruth
Group646-536-7012lroth@theruthgroup.com
Media ContactKirsten ThomasThe Ruth Group(508)
280-6592kthomas@theruthgroup.com
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