Bloodstream Infections
– From Threats to Solutions; Stocks to Watch: Citius Pharmaceuticals, Inc.
(Nasdaq: $CTXR), BD (Becton, Dickinson and Company) (NYSE: $BDX), CorMedix Inc.
(Nasdaq: $CRMD), Vir Biotechnology, Inc. (Nasdaq: $VIR), Abbott Laboratories (NYSE:
$ABT)
July
11, 2024 - Investorideas.com, a
go-to investing platform releases the second of a two-part series looking at recent
news and developments in the blood infections treatment market, featuring Citius
Pharmaceuticals, Inc. (Nasdaq:CTXR), a
late-stage biopharmaceutical company dedicated to the development and
commercialization of first-in-class critical care products. The Company's diversified
pipeline includes two late-stage product candidates.
“Bloodstream infections (BSI) are a growing
threat to public health worldwide. The 2 million cases of BSIs that occur
annually in North America and Europe are associated with 250,000 deaths, making
BSIs the leading cause of mortality from infection”, says a recent
report in the Journal of
Clinical Microbiology.
Citius
Pharmaceuticals, Inc. (Nasdaq:CTXR) just announced
expected milestones in the second half of calendar 2024 and recapped key
achievements year-to-date.
Citius
reported it has significantly advanced its two late-stage product candidates in
the first six months of 2024, and expects several key milestones in the near
term.
Paid news
dissemination for Citius Pharmaceuticals.
Read this article,
featuring CTXR in full at: https://www.investorideas.com/news/2024/biotech/07114Bloodstream-Infections-Stocks.asp
Citius
recently announced positive topline data from the Phase 3 study of Mino-Lok® in
catheter-related bloodstream infections (CRBSIs). Primary and secondary
endpoints were met with statistical significance.
Next
steps for the Mino-Lok program are to prepare a submission to the U.S. Food and
Drug Administration (FDA) and schedule a Type B meeting.
Mino-Lok
(MLT), a novel antibiotic lock solution that combines minocycline, ethanol and
edetate disodium, is designed to treat patients with catheter-related blood
stream infections. Citius licensed Mino-Lok from an affiliate of The University
of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an
alternative to removing and replacing a central venous catheter (CVC), which
may lead to a reduction in serious adverse events and cost savings to the
healthcare system. If approved, Mino-Lok would be the first and only
FDA-approved treatment that salvages central venous catheters that cause
central line-related blood stream infections.
In
late May, Citius announced positive
topline results of its pivotal Phase 3 clinical trial of
Mino-Lok®, a novel antibiotic lock solution designed to salvage catheters in
patients with central line-associated infections (CLABSI) or catheter-related
bloodstream infections (CRBSI). The study met its primary endpoint with a
statistically significant improvement in the time to failure event in patients
receiving Mino-Lok compared to Control arm patients receiving
clinician-directed anti-infective lock solution. The data demonstrate that
Mino-Lok is well-tolerated.
"We
are extremely pleased by the strong results of the trial, which demonstrate the
safety and efficacy of Mino-Lok in preserving indwelling catheters in patients
with bloodstream infections. The data indicate, with a high degree of
statistical significance, that Mino-Lok outperforms anti-infective lock solutions
utilized in patients with CLABSI or CRBSI in the study's control arm. We
believe Mino-Lok could potentially set a new standard of care (SOC) as an
adjunct therapy in the treatment of patients with bloodstream infections. This
therapy offers a non-invasive treatment option compared to catheter removal and
replacement," stated Leonard Mazur, Chairman and Chief Executive Officer
of Citius.
"We
look forward to engaging with the US Food and Drug Administration (FDA) to
determine the optimal path forward for Mino-Lok. Our focus remains on improving
outcomes for patients and offering a much-needed alternative to the current
practice of catheter removal and replacement," added Mazur.
Mino-Lok
Phase 3 Trial Design
MDA
2013-0039 (NCT02901717) is a completed Phase 3 multicenter, randomized,
open-label, active-controlled assessor-blinded trial conducted to evaluate the
safety and efficacy of Mino-Lok as an adjunctive therapy to systemic
anti-infectives for the treatment of catheter-related bloodstream infections
(CRBSI) and central line-associated infections (CLABSI).
More from the news: A total
of 241 patients in the U.S. and India, with an indwelling central venous
catheter before the onset of a bloodstream infection, were randomized in a 1:1
ratio to receive either Mino-Lok or SOC site-specific anti-infective lock
solution plus SOC systemic antibiotics. Enrollment was not limited to patients
with specific types of catheters. Patients in the Mino-Lok arm received one
Mino-Lok dose daily with a dwell time of two to four hours for a total of seven
doses over a period of up to 15 days.
The
primary endpoint for this study is the time to a catheter failure event between
randomization and test of cure (TOC) at six weeks, measured in days following
randomization. Additional secondary outcome measures include overall success,
microbiological eradication, and clinical cure, among others.
For
subjects in the Control arm, the investigator determined the antibiotic used in
the lock, dose, dwell time, and number of days of administration based on
institutional standards or Infectious Diseases Society of America (IDSA)
guidelines.
TOPLINE RESULTS
Efficacy:
The
primary endpoint in the study was time to catheter failure between
randomization and six-weeks following the first dose of Mino-Lok or SOC lock
solution. Catheter failure was defined as the inability to administer study
lock solution, catheter removal for any infection-related reason (including
worsening clinical signs and symptoms or persistence or recurrence of baseline
pathogen, or new infection), and all-cause mortality.
Results
of blinded-assessor clinical outcome analyses in all randomized patients
demonstrated that Mino-Lok achieved its primary endpoint:
Time
to catheter failure events in patients receiving Mino-Lok therapy occurred
substantially later than in patients in the Control arm (p value = 0.0006)
Median
time-to-failure (MTF) of Control arm: 33 days; 95% confidence interval (CI) (14
days – 44 days; n = 122)
Median
time-to-failure (MTF) of Mino-Lok arm: MTF exceeded the time the patients were
on trial and therefore not estimable (NE); 95% CI (50 days - NE; n = 119)
The
hazard ratio of this study was 0.53
The
critical secondary endpoints included the proportion of patients at six weeks
with overall treatment success including no catheter failure, clinical cure
(absence of baseline clinical signs and symptoms of infection or improvement of
clinical signs and symptoms such that no additional therapy was necessary), or
microbiological eradication (absence of the baseline pathogen).
Results
in all randomized patients who received at least one dose of study lock
solution demonstrate overall treatment success in 57.1% of patients in the
Mino-Lok arm and 37.7% of patients in the Control arm (p=0.0025).
Safety:
Mino-Lok
is designed for intracatheter instillation and is not for intravenous injection
or systemic circulation.
No
serious adverse events were drug-related
Serious
adverse events occurred in 45.1% of patients in the Mino-Lok arm and 46.1% of patients
in the Control arm
BD
(Becton, Dickinson and Company) (NYSE:BDX), a leading global
medical technology company, today issued the following statement related to a US FDA letter to
health care providers regarding the supply of blood culture vials:
Nikos
Pavlidis, worldwide president of BD Diagnostic Solutions said, "BD is
experiencing reduced availability of blood culture vials from our supplier. We
understand the critical role that blood culture testing plays in diagnosing and
treating infections and are taking all available measures to address this
important issue, including providing the supplier our manufacturing expertise,
using air shipments, modifying BD manufacturing schedules for rapid production,
and collaborating with the U.S. Food and Drug Administration to review all
potential options to mitigate delays in supply. As an additional stopgap
measure, our former supplier of glass vials will restart production to help
fill the intermittent gap in supply.
"We
take our responsibility to support health care providers and patients very
seriously and, while we are able to meet the majority of global demand, we are
taking all available measures to address this important issue. BD BACTEC™ blood
culture vials are being allocated manually so we can best mitigate any impact
to patient care. Customers have been advised to prioritize the use of blood
culture vials based on clinical needs and following guidelines, such as the
most recent update from the Infectious Disease and Society of America and/or
the World Health Organization.
"While
this supplier issue is not expected to have a material financial impact on BD,
we are fully focused on returning the supply of blood culture vials to normal
levels."
CorMedix
Inc. (Nasdaq:CRMD), a
biopharmaceutical company focused on developing therapeutic products for
life-threatening diseases and conditions, recently announced that it
has commenced commercialization of DefenCath® (taurolidine and heparin) to
outpatient dialysis centers and vascular access clinics where patients receive
outpatient dialysis and catheter placement services. The outpatient launch coincides
with the effective date of July 1st for outpatient reimbursement of DefenCath®
as directed by the Center for Medicare & Medicaid Services (CMS).
Late
last year, CorMedix announced that
the US Food and Drug Administration (FDA) had approved DefenCath® (taurolidine
and heparin) catheter lock solution (CLS) to reduce the incidence of
catheter-related bloodstream infections (CRBSIs) for the limited population of
adult patients with kidney failure receiving chronic hemodialysis through a
central venous catheter (CVC). DefenCath® is the first and only FDA-approved
antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up
to 71% in a Phase 3 clinical study.
Vir
Biotechnology, Inc. (Nasdaq:VIR), an
immunology company focused on powering the immune system to transform lives by
treating and preventing infectious diseases and other serious conditions,
including viral-associated diseases, recently announced that
the U.S. Food and Drug Administration (FDA) has cleared its investigational new
drug (IND) application and granted Fast Track designation for the combination
of tobevibart and elebsiran for the treatment of chronic hepatitis delta
infection. Tobevibart, an investigational monoclonal antibody, and elebsiran,
an investigational small interfering ribonucleic acid, are currently being
evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta clinical trial,
with complete 24-week treatment data on track to be reported in the fourth
quarter.
"The
IND clearance and Fast Track designation from the FDA, along with the
encouraging preliminary data from our Phase 2 hepatitis delta trial, underscore
the potential of tobevibart and elebsiran to transform the treatment landscape
for people living with this severe and life-threatening disease," said
Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. "We are
committed to working closely with health authorities to bring this potential
groundbreaking treatment to patients as quickly as possible, addressing a
critical unmet medical need."
Some
of the biggest pharma companies including Abbott Laboratories (NYSE:ABT) are
grabbing market share in the blood infections testing market, estimated at over
875 Million in 2023.
From
testing to treatments, the life threatening bloodstream infection market is seeing
breakthroughs in technology to answer the call.
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