Entasis Therapeutics Receives Positive Feedback from FDA End-of-Phase 2 Meeting for ETX2514SUL; Signs Rapid Diagnostic Agreem...
February 05 2019 - 8:00AM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel antibacterial products, today announced a successful
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA) regarding ETX2514SUL for the treatment of patients with
pneumonia and bloodstream infections caused by carbapenem-resistant
Acinetobacter baumannii. A Gram-negative bacterium causing severe
infections, A. baummanii is associated with high mortality,
rapidly-increasing rates of antibiotic resistance, growing
significance as a hospital-acquired infection, and limited
treatment options. Following this meeting, Entasis remains on track
to initiate its Phase 3 clinical trial for ETX2514SUL in the first
quarter of 2019.
Further, Entasis announced an agreement with
bioMérieux, a world leader in the field of in vitro diagnostics,
pursuant to which Entasis will incorporate BIOFIRE® FILMARRAY®
Instruments and BIOFIRE® FILMARRAY® Pneumonia Panels into its
global Phase 3 trial for ETX2514SUL for enrollment optimization.
The BIOFIRE System is an FDA-cleared and CE-marked multiplex PCR
system that integrates sample preparation, amplification, and
detection into one closed system. The BIOFIRE System requires only
two minutes of hands-on time and has a total run time of
approximately 45 to 75 minutes, depending on the panel. The BIOFIRE
Pneumonia Panel and the BIOFIRE® FILMARRAY® Pneumonia Panel plus
received FDA clearance and CE-Marking in November 2018. The BIOFIRE
Pneumonia Panels enable fast, accurate, and comprehensive syndromic
testing for lower respiratory tract infections and can identify 33
targets, including A. baumannii, direct from sputum (including
endotracheal aspirate) and bronchoalveolar lavage (including
mini-BAL) sample types.
"We are extremely pleased with the outcome of
our End-of-Phase 2 meeting with the FDA and excited to incorporate
the BIOFIRE System into our Phase 3 clinical trial,” said Robin
Isaacs, Chief Medical Officer, Entasis Therapeutics. “With our
successful FDA meeting and the incorporation of the BIOFIRE System
into the trial for enrollment optimization, we have positioned
ETX2514SUL for success as it enters its next phase of
development.”
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. The FDA has granted
Qualified Infectious Disease Product (QIDP) designation and Fast
Track status to ETX2514SUL for the treatment of hospital-acquired
and ventilator-acquired bacterial pneumonia and bloodstream
infections due to A. baumannii.
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) design of the Phase 3 clinical trial of
ETX2514SUL, including plans to incorporate BIOFIRE Instruments and
Pneumonia Panels into this trial; and (iii) the success of the
Phase 3 clinical trial 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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