- A Phase 3 study of oral zoliflodacin met the primary endpoint
when compared against the combination of injectable ceftriaxone and
oral azithromycin, a current international standard of care.
- Positive top-line study results are a significant milestone in
the development of a first-in-class antibiotic against
drug-resistant Neisseria gonorrhoeae, a high priority
pathogen.
- Groundbreaking antibiotic research and development partnership
model paves the way for development of other antibiotics to address
impact of antimicrobial resistance (AMR).
The Global Antibiotic Research & Development Partnership
(GARDP), in collaboration with Innoviva Specialty Therapeutics, a
subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today that
zoliflodacin, a first-in-class antibiotic, met its primary endpoint
in an unprecedented global pivotal Phase 3 clinical trial. Study
investigators found that oral zoliflodacin demonstrated statistical
non-inferiority of microbiological cure at the urogenital site when
compared to treatment with intramuscular (IM) injection of
ceftriaxone and oral azithromycin, a current global standard of
care regimen. In the study, zoliflodacin was found to be generally
well tolerated and there were no serious adverse events or deaths
recorded in the trial.
This is the first study to address a World Health Organization
priority pathogen that has been sponsored and led by a non-profit
organization. These positive preliminary findings offer hope for
patients with this condition, particularly in the face of rising
antibiotic resistance to current regimens. It also paves the way
for a new research and development model in the global fight
against antimicrobial resistance (AMR). If approved, zoliflodacin
will be the first new antibiotic for treating gonorrhea in
decades.
“This is a significant step forward in the treatment of
gonorrhea, and also shows that GARDP’s public-private partnership
model can play a crucial role in helping to fix the public health
failure at the heart of the global AMR crisis,” said Dr. Manica
Balasegaram, Executive Director of GARDP. “Despite the extremely
high public health value, there has been a lack of investment to
develop new drugs for gonorrhea. This zoliflodacin program
demonstrates that it is possible to develop antibiotic treatments
targeting multidrug-resistant bacteria that pose the greatest
public health threat, and which may not otherwise get
developed.”
With more than 82 million new gonorrhea infections occurring
globally each year, gonorrhea is the third most common sexually
transmitted infection, affecting both men and women in ways that
can result in serious and permanent health consequences. The
bacterium Neisseria gonorrhoeae has gradually developed resistance
to many classes of antibiotics used to treat these infections and
as a result, ceftriaxone, given as a single intramuscular
injection, has become the last available recommended treatment for
gonorrhea globally.
“The outcome of this study is a potential game changer for
sexual health," said Edward W. Hook III, MD, Protocol Chair for the
study and Emeritus Professor of Medicine at the University of
Alabama, in Birmingham. “In addition to the potential benefits for
patients with infections with resistant strains of Neisseria
gonorrhoeae, the potential lack of cross-resistance with other
antibiotics and the oral route of administration will simplify
gonorrhea therapy for clinicians worldwide.”
Recent reports (The Lancet Infectious Diseases) of emergent
ceftriaxone-resistant infections have heightened the urgency for
new antibiotics. Effective treatment options are essential to
reducing the burden of disease for individuals, and to preventing
the spread of highly drug-resistant gonorrhea globally. If left
untreated, gonorrhea can also cause infertility in women,
life-threatening ectopic pregnancies, and pelvic inflammatory
disease.2
“The success of this study could have a profound effect on how
physicians approach gonorrhea infections, as an oral alternative to
an injection could improve patient access and compliance, as well
as help reduce the increasing spread of antibiotic-resistant
strains of the disease,” said Pavel Raifeld, Chief Executive
Officer, Innoviva, Inc. “Such a positive outcome represents an
important milestone for Innoviva Specialty Therapeutics and
reinforces our position as a premier infectious disease and
critical care company.”
Zoliflodacin has a unique mechanism of action in the way that it
inhibits a crucial bacterial enzyme called type II topoisomerase,
which is essential for bacterial function and reproduction.
Previous in-vitro studies have shown that it is active against
multidrug-resistant strains of Neisseria gonorrhoeae, including
those resistant to ceftriaxone and azithromycin, with no
cross-resistance with other antibiotics. Now, the positive results
of this landmark Phase 3 trial confirm that zoliflodacin has the
potential to tackle the most difficult-to-treat gonorrhea
infections.
The Phase 3 trial enrolled a total of 930 patients with
uncomplicated gonorrhea, including women, adolescents, and people
living with HIV, making it the largest clinical trial ever
conducted for a new treatment against gonorrhea infection, with 16
trial sites in regions with a high prevalence of gonorrhea across
five countries, including Belgium, the Netherlands, South Africa,
Thailand, and the U.S. The trial compared a single, oral, 3g dose
of zoliflodacin to a globally recognized standard of care regimen
(500mg ceftriaxone IM plus 1g oral azithromycin) for the treatment
of uncomplicated gonorrhea.
Zoliflodacin met the prespecified statistical test for
non-inferiority when compared to ceftriaxone and oral azithromycin
(5.31% (95%CI 1.38, 8.65%)). Non inferiority of zoliflodacin was
demonstrated within the pre-specified margin of 12% and,
furthermore, within the margin of 10% as specified in U.S. Food and
Drug Administration guidance.
GARDP has the right to register and commercialize the product in
more than three-quarters of the world’s countries, including all
low-income countries, most middle-income countries, and several
high-income countries. GARDP is committed to work with its partners
and local health authorities in markets where zoliflodacin receives
regulatory approval, to help remove access barriers to ensure
treatment is available to address unmet medical needs while
ensuring appropriate and sustainable use. Entasis Therapeutics
Limited, an affiliate of Innoviva Specialty Therapeutics, retains
the commercial rights for zoliflodacin in the major markets in
North America, Europe, Asia-Pacific, and Latin America.
This GARDP-led trial was funded with support from the
governments of Germany (BMBF and BMG), UK (GAMRIF, part of DHSC,
and DFID), Japan (MHLW), the Netherlands (Ministries of VWS and
BZ), Switzerland (FOPH), The Grand Duchy of Luxembourg, as well as
the Canton of Geneva, South African Medical Research Council
(SAMRC), and the Leo Model Foundation. This builds on the critical
Phase 2 clinical trial sponsored by the U.S. National Institute of
Allergy and Infectious Diseases (NIAID).
About GARDP The Global Antibiotic Research &
Development Partnership (GARDP) is a Swiss not-for-profit
organization developing new treatments for drug-resistant
infections that pose the greatest threat to health. GARDP was
created by the World Health Organization and the Drugs for
Neglected Diseases initiative (DNDi) in 2016 and legally founded in
2018 to ensure that everyone who needs antibiotics receives
effective and affordable treatment. GARDP is funded by the
governments of Australia, Germany, Japan, Monaco, the Netherlands,
the Public Health Agency of Canada, South Africa, Switzerland, the
United Kingdom, the Canton of Geneva, as well as the European
Union, Wellcome Trust and private foundations. GARDP is registered
under the legal name GARDP Foundation. http://www.gardp.org/
About Innoviva Specialty Therapeutics Innoviva Specialty
Therapeutics, a subsidiary of Innoviva, Inc., is focused on
delivering innovative therapies in critical care and infectious
disease. Innoviva Specialty Therapeutics’ products, through its
affiliate, La Jolla Pharmaceutical Company, include GIAPREZA®
(angiotensin II), approved to increase blood pressure in adults
with septic or other distributive shock, and XERAVA® (eravacycline)
for the treatment of complicated intra-abdominal infections in
adults. Innoviva Specialty Therapeutics’ products, through its
affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam
for injection; durlobactam for injection), co-packaged for
intravenous use approved for the treatment of adults with
hospital-acquired bacterial pneumonia and ventilator-associated
bacterial pneumonia caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter). Our Phase 3
development pipeline includes zoliflodacin, a novel treatment for
uncomplicated gonorrhea in adults. For more information about
Innoviva Specialty Therapeutics, please visit here.
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version on businesswire.com: https://www.businesswire.com/news/home/20231101634842/en/
Media Contacts:
Innoviva Specialty Therapeutics David Patti Corporate
Communications +1 908.421.5971 david.patti@inva.com
GARDP Dominique De Santis Head of Communications +41 78 911 5327
ddesantis@gardp.org
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