GARDP and Entasis Therapeutics Initiate Global Phase 3 Trial of Zoliflodacin, a First-in-Class Oral Antibiotic for the Treatm...
30 September 2019 - 3:00PM
The Global Antibiotic Research and Development Partnership (GARDP),
a not for profit organization developing new treatments for drug
resistant infections, and Entasis Therapeutics (NASDAQ: ETTX), a
clinical-stage biopharmaceutical company focused on the discovery
and development of novel antibacterial products, today jointly
announced the initiation of a global phase 3 pivotal trial of
zoliflodacin. Zoliflodacin is a novel, first-in-class oral
antibiotic being developed for the treatment of uncomplicated
gonorrhea. Following positive phase 2 results previously published
in the New England Journal of Medicine (NEJM), Entasis and GARDP
have partnered to complete late stage development, with GARDP
fully-funding and sponsoring the global phase 3 trial. Gonorrhea is
a common sexually transmitted infection (STI) affecting both men
and women, particularly between 15 and 24 years old.1 Globally the
infection rate of gonorrhea is increasing, with 87 million new
cases estimated each year.2 Uncomplicated gonorrhea infections
carry high morbidity, enhance transmission of other sexually
transmitted diseases and are highly stigmatized. Gonorrhea is
caused by the bacterium Neisseria gonorrhoeae, which has
progressively developed resistance to globally-recommended
treatments and has been identified by the World Health Organization
as among a family of ‘priority pathogens’ posing the greatest
threat to global health.3
Teodora Wi, WHO Medical Officer for STIs, said: “Gonorrhea rates
are increasing, resulting in substantial morbidity and a huge
psychosocial and economic cost worldwide. At the same time, we are
observing increasing resistance to the last line-options for
treatment in Neisseria gonorrhoeae. That is why there is an urgent
need for new treatments and why the World Health Organization is
supporting GARDP.”
"The initiation of the phase 3 trial of zoliflodacin is an
important milestone and brings hope for people affected by this
disease. Our partnership with Entasis is critical for preventing
the dire scenario of untreatable gonorrhea and controlling this
infection,” said Dr. Manica Balasegaram, Executive Director of
GARDP. “The global nature of the trial, across four continents,
represents our commitment to ensuring this treatment is available
to anyone who needs it, wherever they live.” The trial is expected
to enroll approximately 1,000 adults with urogenital gonorrhea from
clinical trial sites in the United States, Netherlands, Thailand
and South Africa. Patients included in the trial will be randomized
(2:1) to receive either zoliflodacin or a combination of
ceftriaxone and azithromycin and will be assessed one week later
for persistence of the infection. Data from the phase 3 clinical
trial is anticipated in 2021. “The phase 3 trial of zoliflodacin
marks the last major clinical trial for our gonorrhea program.
Entasis’ partnership with GARDP reflects our commitment to enable
global access of this potential novel oral treatment for a disease
that is quickly becoming resistant to all currently available
antibiotics,” said Manos Perros, PhD, President and Chief Executive
Officer of Entasis Therapeutics. “We both believe a solution lies
with an oral treatment option, which not only overcomes existing
resistance but also offers significant benefits compared to the
current standard of care of one or more intramuscular injections.
We look forward to continuing our relationship with GARDP as we
progress this global phase 3 trial.” Under the partnership
agreement, GARDP is responsible for the phase 3 trial and
pharmaceutical development activities for zoliflodacin to support
regulatory approval and market access and availability. GARDP has
commercial rights to zoliflodacin in up to 168 low- and select
middle-income countries, while Entasis retains commercial rights in
the rest of the world. The phase 3 trial initiation marks an
important milestone for this novel industry and non-profit
partnership in jointly developing a novel antibiotic and building a
strategic plan for successful market access within the countries
that have high rates of gonorrhea and for patients who need it
most.
1 Gonorrhea: CDC Fact Sheet2 More than 1 million new
curable sexually transmitted infections every day3 WHO publishes
list of bacteria for which new antibiotics are urgently needed
About GARDPThe Global Antibiotic Research and
Development Partnership (GARDP) is a not-for-profit developing new
and improved treatments for drug resistant infections. Created by
the WHO and Drugs for Neglected Diseases initiative (DNDi), GARDP
is an essential element of the WHO Global Action Plan on
Antimicrobial Resistance. www.gardp.org About
Entasis Entasis 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), 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 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 enrolment 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.
Contacts
GARDP media contact Caleb Starrenburg
+41792540207 cstarrenburg@gardp.org
Entasis media contact Kirsten Thomas The Ruth
Group +1(508) 280-6592 kthomas@theruthgroup.com
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