- Sulbactam-durlobactam is the first pathogen-targeted therapy
under investigation for the treatment of hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia
caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter).
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc.
(Nasdaq: INVA) focused on delivering innovative therapies in
critical care and infectious disease, today announced that The
Lancet Infectious Diseases published detailed results from the
pivotal Phase 3 ATTACK trial of sulbactam-durlobactam, the first
pathogen-targeted therapy being studied 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). The study – Efficacy and Safety of
Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients
with Serious Infections due to Acinetobacter
Baumannii-Calcoaceticus Complex: a multicentre, randomised,
active-controlled, Phase 3, non-inferiority clinical trial (ATTACK)
– was first published online on May 11.
The Phase 3 trial evaluated the safety and efficacy of
sulbactam-durlobactam versus colistin in patients with infections
caused by Acinetobacter. In the trial, sulbactam-durlobactam
demonstrated statistical non-inferiority versus colistin for the
primary endpoint of 28-day all-cause mortality in patients with
carbapenem-resistant Acinetobacter infections and a significant
difference in clinical cure rates. Sulbactam-durlobactam also
exhibited a favorable safety profile with a statistically
significant lower incidence of nephrotoxicity as measured by
modified Risk–Injury–Failure–Loss and End-stage kidney disease
(RIFLE) criteria.
“Serious bacterial infections caused by Acinetobacter
baumannii-calcoaceticus complex often result in death, as the
pathogen is increasingly resistant to carbapenems and other
existing agents,” said Keith Kaye, MD, MPH, Chief, Division of
Allergy, Immunology and Infectious Diseases at Rutgers Robert Wood
Johnson Medical School. “The safety and efficacy demonstrated
during the Phase 3 ATTACK trial by sulbactam-durlobactam, which was
designed specifically for treating serious infections caused by
Acinetobacter, are very promising, and provide hope that we’ll have
a novel, desperately needed, effective treatment option against
this lethal pathogen.”
Infections caused by drug-resistant Acinetobacter are serious
and life-threatening conditions associated with high morbidity and
mortality1 and long, expensive hospital stays. Acinetobacter is
resistant to penicillins and has also acquired resistance genes for
almost all antibiotics used to treat Gram-negative bacteria,
including fluoroquinolones, aminoglycosides, cephalosporins, and
carbapenems.
The Centers for Disease Control and Prevention (CDC) has
identified carbapenem-resistant micro-organisms as an urgent
threat2. Globally, Acinetobacter baumannii was among the top six
leading pathogens for deaths associated with resistance in 20193.
Carbapenem-resistant Acinetobacter is considered a Priority 1
pathogen by the World Health Organization (WHO)4.
The New Drug Application (NDA) for sulbactam-durlobactam, filed
by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty
Therapeutics, is currently under Priority Review by the U.S. Food
and Drug Administration (FDA). On April 17, 2023, the FDA’s
Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously
12-0 in support of approval based on a favorable benefit-risk
assessment of sulbactam-durlobactam for the treatment of adults
with hospital-acquired bacterial pneumonia and
ventilator-associated bacterial pneumonia caused by susceptible
strains of Acinetobacter. The sulbactam-durlobactam NDA has a
Prescription Drug User Fee Act (PDUFA) target action date of May
29, 2023.
About Acinetobacter Members of the Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative,
opportunistic human pathogens that predominantly infect critically
ill patients often resulting in severe pneumonia and bloodstream
infections. They can also infect other body sites, such as the
urinary tract and the skin. Acinetobacter is considered a global
threat in the healthcare setting due in part to its ability to
acquire multidrug resistance.
In the U.S., there are an estimated 40,000 to 80,000 cases of
Acinetobacter each year5, and about 40 percent of those are
carbapenem-resistant Acinetobacter6. Globally, there are about a
million cases each year of Acinetobacter, and about two-thirds of
those are carbapenem-resistant Acinetobacter baumannii5. More than
300,000 global deaths annually are associated with
carbapenem-resistant Acinetobacter7.
About sulbactam-durlobactam Sulbactam-durlobactam is an
intravenous, or IV, investigational drug that is a combination of
sulbactam, a beta-lactam antibacterial, and durlobactam, a
beta-lactamase inhibitor, being developed for the treatment of
hospital-acquired bacterial pneumonia and ventilator-associated
bacterial pneumonia caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter).
Sulbactam-durlobactam has been designated a Qualified Infectious
Disease Product by the FDA, a designation that aims to spur
development of new antibiotics for serious and life-threatening
infections. In November 2022, the FDA accepted the New Drug
Application (NDA) for sulbactam-durlobactam for Priority Review and
set a Prescription Drug User Fee Act (PDUFA) target date of May 29,
2023.
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. In addition, through its affiliate, Entasis Therapeutics
Inc., sulbactam-durlobactam is an investigational, targeted
antibiotic in late-stage development for the treatment of
hospital-acquired bacterial pneumonia and ventilator-associated
bacterial pneumonia caused by susceptible strains of Acinetobacter
baumannii-calcoaceticus complex (Acinetobacter). For more
information about Innoviva Specialty Therapeutics, please visit
here.
About Innoviva Innoviva, Inc., is a diversified holding
company with a portfolio of royalties and other healthcare assets,
including Innoviva Specialty Therapeutics, a subsidiary focused on
delivering innovative therapies in critical care and infectious
disease. Innoviva’s royalty portfolio includes respiratory assets
partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO®
ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO®
ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the
Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva
is entitled to receive royalties from GSK on sales of RELVAR®/BREO®
ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are
trademarks of the GSK group of companies. For more information on
Innoviva, please visit here.
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® and, formerly, TRELEGY®
ELLIPTA® 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 beyond the existing respiratory portfolio); 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). 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.
________________ 1 Tala, B., Jad, A., Claude, A., Jihad, I.,
Chantal, L., Rakan, N.,& Eid, A. (2017). Risk Factors, Clinical
Presentation, and Outcome of Acinetobacter baumannii Bacteremia.
Front. Cell. Infect. Microbiol., 04 May 2017, Sec. Molecular
Bacterial Pathogenesis Volume 7 – 2017:
https://doi.org/10.3389/fcimb.2017.00156 2 Centers for Disease
Control and Prevention, “Carbapenem-resistant Acinetobacter
baumannii (CRAB): An urgent public health threat in United States
healthcare facilities,” August 2021:
https://arpsp.cdc.gov/story/cra-urgent-public-health-threat 3
Antimicrobial Resistance Collaborators. Global burden of bacterial
antimicrobial resistance in 2019: a systematic analysis. Lancet.
2022; 399(10325):629-655.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
4 World Health Organization, “WHO publishes list of bacteria for
which new antibiotics are urgently needed,” February 27, 2017:
https://www.who.int/news/item/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed
5 Spellberg B, Rex JH. The value of single-pathogen antibacterial
agents. Nat Rev Drug Discov. 2013 Dec;12(12):963. doi:
10.1038/nrd3957-c1. Epub 2013 Nov 15. 6 Centers for Disease Control
and Prevention. Antibiotic Resistance & Patient Safety Portal.
“Carbapenem-resistant Acinetobacter,” May 2023:
https://arpsp.cdc.gov/profile/antibiotic-resistance/carbapenem-resistant-acinetobacter
7 Antimicrobial Resistance Collaborators. Global burden of
bacterial antimicrobial resistance in 2019: a systematic analysis.
Lancet. 2022; 399(10325):629-655. Supplementary Material.
Supplementary appendix.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
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