Entasis Therapeutics Announces Sulbactam-Durlobactam Expanded Access Program for Patients in the U.S.
January 26 2021 - 8:00AM
Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage
biopharmaceutical company focused on the discovery and development
of novel antibacterial products, announced today the availability
of an expanded access program (EAP) for sulbactam-durlobactam or
SUL-DUR, an investigational drug, for U.S. patients with
Acinetobacter baumannii infections, including carbapenem and
multidrug resistant strains.
“The ability to provide access to patients in
need is consistent with the Entasis mission,” said David Altarac,
M.D., Chief Medical Officer. “We are excited to have in place an
EAP for patients who are not eligible to participate in our study
and who are suffering from a serious and life-threatening infection
caused by drug resistant Acinetobacter.”
In cooperation with the FDA, expanded access,
also referred to as compassionate use, is a potential pathway for a
patient with an immediately life-threatening condition or serious
disease or condition to gain access to an investigational medical
product for treatment outside of clinical trials when no comparable
or satisfactory alternative therapy options are available. In this
circumstance, Entasis Therapeutics can provide a requesting
physician with pre-approval access to SUL-DUR for the treatment of
the physician’s patient if specific conditions are met and there is
adequate availability of drug supply.
Physicians seeking pre-approval access for
patients with no alternative treatment options should submit their
requests to Expandedaccess@entasistx.com. At this time, the EAP is
open to patients only in the U.S.
About SUL-DURSUL-DUR is an
intravenous, or IV, investigational drug that is a combination of
sulbactam, an IV β-lactam antibiotic, and durlobactam, a novel
broad-spectrum IV β-lactamase inhibitor, or BLI, that we are
developing for the treatment of infections caused by Acinetobacter
baumannii, including carbapenem-resistant strains. We initiated
ATTACK, our single Phase 3 registration trial in April 2019. ATTACK
is a global Phase 3 registration trial that is actively enrolling
patients at sites in 17 countries including China.
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’ pathogen-targeted design platform
has produced a pipeline of product candidates, including
sulbactam-durlobactam (targeting Acinetobacter baumannii
infections), zoliflodacin (targeting Neisseria gonorrhoeae
infections), ETX0282CPDP (targeting Enterobacteriaceae infections)
and ETX0462 (targeting Pseudomonas infections). For more
information, visit www.entasistx.com.
Entasis Forward-looking
StatementsThis 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. 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, changes in the regulatory
environment, failure of Entasis’ collaborators to support or
advance collaborations or product candidates and unexpected
litigation or other disputes. Many of these factors are beyond
Entasis’ control. These and other risks and uncertainties are
described more fully in the Entasis’ filings with the U.S.
Securities and Exchange Commission, including the section titled
“Risk Factors” contained therein. Forward-looking statements
contained in this announcement are made as of this date, and 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.
Company Contact
Kyle Dow Entasis
Therapeutics (781) 810-0114 kyle.dow@entasistx.com
Investor Relations ContactJames
SaliernoThe Ruth Group(646) 536-7035 / (646)
536-7028jsalierno@theruthgroup.com
Media ContactAnnika ParrishThe
Ruth Group(508) 280-6592aparrish@theruthgroup.com
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