- Single-dose, oral zoliflodacin achieved 90.9% microbiological
cure rate, demonstrating statistical non-inferiority compared to
current global standard of care
- Pivotal Phase 3 data to be presented by the Global Antibiotic
Research & Development Partnership (GARDP) in a Scientific
Sessions Oral Presentation
- First collaborative study between industry and a non-profit to
address a World Health Organization high priority pathogen and U.S.
Centers for Disease Control urgent threat
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva,
Inc. (NASDAQ: INVA), today announced that positive results from the
Phase 3 oral zoliflodacin trial will be highlighted in an oral
presentation given by the Global Antibiotic Research &
Development Partnership (GARDP) at the European Society of Clinical
Microbiology and Infectious Disease Global Congress (ESCMID Global
2024) taking place April 27-30, 2024, in Barcelona, Spain.
Zoliflodacin is a first-in-class spiropyrimidinetrione, single
dose, oral antibiotic that is being developed in partnership with
GARDP for the treatment of uncomplicated gonorrhea.
“As a single dose, oral antibiotic, zoliflodacin, if approved,
could have a profound effect on how physicians across the globe
approach the treatment of gonorrhea infections, potentially
improving patient access and compliance while helping to reduce the
spread of antibiotic-resistant strains of gonorrhea,” said David
Altarac, M.D., Chief Medical Officer of Innoviva Specialty
Therapeutics. “The presentation of these data for this innovative
investigational therapy is an important step in advancing our
clinical pipeline strategy, as we now turn our focus on regulatory
filing requirements in the U.S.”
“Presenting these findings to the scientific community for the
first time is a significant milestone in the journey of this
important antibiotic in the fight against Neisseria gonorrhoeae, a
World Health Organization priority pathogen,” said Dr. Alison
Luckey, Senior Medical Lead for GARDP’s Sexually Transmitted
Infections programme. “These positive findings not only represent a
step forward in the treatment of gonorrhoea if approved, but also
demonstrate the pivotal role that this public-private partnership
between GARDP and Innoviva Specialty Therapeutics has in addressing
the public health failure at the heart of the global antimicrobial
resistance (AMR) crisis.”
In November 2023, the two organizations announced that the Phase
3 zoliflodacin trial met its primary endpoint, demonstrating
statistical non-inferiority of microbiological cure at the
urogenital site when compared to treatment with intramuscular
injection of ceftriaxone and oral azithromycin, currently the only
remaining global standard of care regimen for the treatment of
uncomplicated gonorrhea.
In addition to the Phase 3 topline data, GARDP will also be
presenting three additional posters highlighting details of
zoliflodacin’s safety profile and additional microbiological data
from the Phase 3 trial, as well as data from a drug-drug
interaction pharmacokinetic trial. GARDP and Innoviva Specialty
Therapeutics plan to submit the Phase 3 zoliflodacin data for
future publication in a medical journal.
Beyond the zoliflodacin posters, Innoviva Specialty Therapeutics
will also be presenting three additional posters at the meeting
that feature new data for XERAVA® and XACDURO®.
Results from the Phase 3 Zoliflodacin Trial
The Phase 3 non-inferiority trial analyzed 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 intramuscular [IM] plus 1g oral
azithromycin). The primary efficacy endpoint was microbiological
response at the urogenital site (cure or failure) at the
Test-of-Cure (ToC) visit 6+/-2 days after treatment. Secondary
analyses included microbiological cure at rectal or pharyngeal
sites and safety.
The trial met its primary efficacy endpoint, with zoliflodacin
(oral, 3g dose) demonstrating non-inferiority to ceftriaxone (IM,
500mg) plus azithromycin (oral, 1g). In the micro-intent-to-treat
(micro-ITT) population (n=744), zoliflodacin achieved a
microbiological cure rate of 90.9%, a 5.3% difference compared to
ceftriaxone and azithromycin which achieved a 96.2% cure rate (95%
CI: 1.4%, 8.7%). Microbiological cure rates at extragenital sites
were comparable between treatment arms (secondary endpoints).
Oral zoliflodacin 3g was generally well tolerated and emergent
adverse events were comparable between treatment arms (46.2% vs
46.4%). No deaths or other serious adverse events were
reported.
Details for the ESCMID Global 2024 presentations are as
follows:
Oral presentation
Title: Oral zoliflodacin is non-inferior to a combination
of ceftriaxone and azithromycin for treatment of uncomplicated
urogenital gonorrhoea: results of a large global Phase 3 randomized
controlled trial Presenter/Author: Alison Luckey Oral
session #: 246 Session: 05. New antibacterial agents,
PK/PD & Stewardship – Therapeutic expedition: mining old and
new drugs and dosing strategies Date and time: Tuesday,
April 30, 2024; 8:30-10:30 CEST Location: Hall H
Poster presentations
Title: Safety profile of oral zoliflodacin for
uncomplicated gonorrhoea in a Phase 3 trial Author:
Gabrielle Kornman, et al. Poster #: 2724 Session: 5e.
Safety, hypersensitivity, and adverse effects of treatment Date
and time: Sunday, April 28, 2024; 12:00 CEST Location:
Poster Area, Sector A, Row 23, Position 2
Title: Pharmacokinetics of zoliflodacin in healthy
participants in the presence of itraconazole suggest no clinically
meaningful CYP3A4-mediated drug-drug interactions Author:
Alison Luckey, et al. Poster #: 2424 Session: 5b.
Pharmacokinetics/pharmacodynamics of antibacterial drugs &
therapeutic drug monitoring (incl lab methods, models, in vitro and
in vivo studies) Date and time: Sunday, April 28, 2024;
12:00 CEST Location: Poster Area, Sector B, Row 16, Position
26
Title: Antimicrobial susceptibility of baseline Neisseria
gonorrhoeae isolates from participants recruited in the global
zoliflodacin Phase 3 randomised controlled trial Author:
Alison Luckey, et al. Poster #: 2527 Session: 5c. New
or repurposed antibacterial agents: clinical studies and randomised
trials Date and time: Sunday, April 28, 2024; 12:00 CEST
Location: Poster Area, Sector B, Row 18, Position 17
Title: Eravacycline susceptibility against Gram-positive
pathogens, collected in Europe during 2022 Author: Stephen
Hawser, et al. Poster #: 1281 Session: 3a. Resistance
surveillance & epidemiology: MRSA, VRE & other
Gram-positives Date and time: Monday, April 29, 2024; 12:00
CEST Location: Poster Area, Sector B, Row 1, Position 8
Title: In vitro activity of eravacycline against
Enterobacterales and non-fermenter clinical isolates, including
resistant isolates, collected in Europe during 2022 Author:
Stephen Hawser, et al. Poster #: 1421 Session: 3b.
Resistance surveillance & epidemiology: Gram-negatives Date
and time: Monday, April 29, 2024; 12:00 CEST Location:
Poster Area, Sector A, Row 4, Position 12
Click here for full XERAVA safety and prescribing
information or go to www.xerava.com.
Title: In vitro activity of sulbactam/durlobactam in
combination with cefepime against Gram-negative bacterial isolates
from a recent Phase 3 clinical trial Author: Sarah McLeod,
et al. Poster #: 1816 Session: 3f. Clinical outcome
of resistant infections (retrospective and prospective studies,
excl clinical trials of new drugs) Date and time: Monday,
April 29, 2024; 12:00 CEST Location: Poster Area, Sector B,
Row 12, Position 3
Click here for full XACDURO safety and prescribing
information or go to www.xacduro.com.
The oral presentation and posters will be available on the
“Events & Presentations” page of the Investors Relations
section of Innoviva’s website following their presentation at
ESCMID Global 2024.
About Oral Zoliflodacin
Zoliflodacin is a potential first-in-class, orally administered,
single dose antibiotic with a novel mechanism of action that is
currently in development for the treatment of uncomplicated
gonorrhea. In a Phase 3 clinical trial, zoliflodacin met the
primary efficacy endpoint by demonstrating non-inferiority compared
to a globally recognized standard of care regimen (500mg
ceftriaxone intramuscular [IM] plus 1g oral azithromycin).
Zoliflodacin was found to be generally well tolerated with the
overall rate of adverse events comparable between the two arms, and
the majority of adverse events were mild to moderate. 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.
About Gonorrhea
Gonorrhea is widely prevalent worldwide, with the World Health
Organization estimating 82 million new cases worldwide in 20201,
making it the second most prevalent sexually transmitted bacterial
infection worldwide after Chlamydia trachomatis. In the U.S.,
gonorrhea is the second most prevalent sexually transmitted
bacterial infection, with an estimated 1.6 million new infections
each year.2 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.
About GARDP
The Global Antibiotic Research & Development Partnership
(GARDP) is a not-for-profit organization that develops new
antibiotic treatments for drug-resistant bacterial infections that
pose the greatest threat to human health, and makes them accessible
to the people who need them. It puts public health needs at the
centre of antibiotic drug development to address the immediate
crisis of antimicrobial resistance (AMR). Its work 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, the European Union (via the
Health Emergency Preparedness and Response Authority), as well as
the RIGHT Foundation, Wellcome and other private foundations. GARDP
was created by the World Health Organization and the Drugs for
Neglected Diseases initiative (DNDi) in 2016 and legally registered
as the GARDP Foundation in Geneva, Switzerland in 2018.
www.gardp.org.
http://www.gardp.org
About Innoviva Specialty Therapeutics, Inc.
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 and follow us on
X (formerly Twitter) and LinkedIn.
About Innoviva, Inc.
Innoviva is a diversified holding company with a core royalties
portfolio, a leading critical care and infectious disease platform
known as Innoviva Specialty Therapeutics (IST), and a portfolio of
strategic investments in healthcare assets. Innoviva’s royalty
portfolio includes respiratory assets partnered with Glaxo Group
Limited (GSK). Innoviva is entitled to receive royalties from GSK
on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s
other innovative healthcare assets include infectious disease and
critical care assets stemming from acquisitions of Entasis
Therapeutics, including 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 and the investigational
zoliflodacin currently being developed for the treatment of
uncomplicated gonorrhea, and La Jolla Pharmaceutical Company,
including 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.
For more information about Innoviva, please visit here and
follow us on LinkedIn.
ANORO®, RELVAR®, BREO® and TRELEGY® are trademarks of the GSK
group of companies.
Forward Looking Statements
This press release contains certain “forward-looking” statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995 regarding, among other things, statements relating to
goals, plans, objectives, and future events. Innoviva intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. The words “anticipate”, “expect”,
“goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”,
“target” and similar expressions are intended to identify such
forward-looking statements. Such forward-looking statements involve
substantial risks, uncertainties, and assumptions. These statements
are based on the current estimates and assumptions of the
management of Innoviva as of the date of this press release and are
subject to known and unknown risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause the
actual results of Innoviva to be materially different from those
reflected in the forward-looking statements. Important factors that
could cause actual results to differ materially from those
indicated by such forward-looking statements include, among others,
risks related to: expected cost savings; lower than expected future
royalty revenue from respiratory products partnered with GSK; the
commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®,
GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these
products have been approved; the strategies, plans and objectives
of Innoviva (including Innoviva’s growth strategy and corporate
development initiatives); the timing, manner, and amount of
potential capital returns to shareholders; the status and timing of
clinical studies, data analysis and communication of results; the
potential benefits and mechanisms of action of product candidates;
expectations for product candidates through development and
commercialization; the timing of regulatory approval of product
candidates; and projections of revenue, expenses and other
financial items; the impact of the novel coronavirus (COVID-19);
the timing, manner and amount of capital deployment, including
potential capital returns to stockholders; and risks related to the
Company’s growth strategy. Other risks affecting Innoviva are
described under the headings “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” contained in Innoviva’s Annual Report on Form 10-K for
the year ended December 31, 2022, and Quarterly Reports on Form
10-Q, which are on file with the Securities and Exchange Commission
(SEC) and available on the SEC’s website at www.sec.gov. Past
performance is not necessarily indicative of future results. No
forward-looking statements can be guaranteed, and actual results
may differ materially from such statements. Given these
uncertainties, you should not place undue reliance on these
forward-looking statements. The information in this press release
is provided only as of the date hereof, and Innoviva assumes no
obligation to update its forward-looking statements on account of
new information, future events or otherwise, except as required by
law.
References
-
https://www.who.int/news-room/fact-sheets/detail/multi-drug-resistant-gonorrhoea#:~:text=Antimicrobial%20resistance%20in%20gonorrhoea%20has,are%20aged%2015%E2%80%9349%20years
-
https://www.cdc.gov/std/gonorrhea/arg/public-health-threat/public-health-threat-text-only.htm#:~:text=Gonorrhea%20is%20the%20second%20most,to%20at%20least%20one%20antibiotic
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version on businesswire.com: https://www.businesswire.com/news/home/20240424323555/en/
Innoviva Specialty Therapeutics David Patti, Corporate
Communications +1 908.421.5971 David.Patti@inva.com Innoviva, Inc.
Investor Relations Argot Partners +1 212.600.1902
Innoviva@argotpartners.com
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