Trial achieves statistically significant
primary endpoint (p=0.0006)
Secondary endpoint demonstrates statistically
significant overall success of Mino-Lok therapy with a greater
percentage of patients retaining their catheters (p=0.0025)
CRANFORD,
N.J., May 21, 2024 /PRNewswire/ -- Citius
Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a
late-stage biopharmaceutical company dedicated to the development
and commercialization of first-in-class critical care products,
today 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).
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
About Mino-Lok
Mino-Lok (MLT) is a novel antibiotic lock
solution that combines minocycline, ethanol with edetate
disodium 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.
About Citius Pharmaceuticals, Inc.
Citius is 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:
Mino-Lok® and LYMPHIRTM. In May 2024, Citius announced positive topline
results of Mino-Lok, its antibiotic lock solution to salvage
catheters in patients with bloodstream infections. The Biologics
License Application for LYMPHIR, a novel IL-2R immunotherapy for an
initial indication in cutaneous T-cell lymphoma, is currently under
review by the FDA with August 13,
2024 assigned as the PDUFA target action date. Citius
previously announced plans to form Citius Oncology, a standalone
publicly traded company with LYMPHIR as its primary asset. LYMPHIR
received orphan drug designation by the FDA for the treatment of
CTCL and PTCL. In addition, Citius completed enrollment in its
Phase 2b trial of CITI-002
(Halo-Lido), a topical formulation for the relief of hemorrhoids.
For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
Such statements are made based on our expectations and beliefs
concerning future events impacting Citius. You can identify these
statements by the fact that they use words such as "will,"
"anticipate," "estimate," "expect," "plan," "should," and "may" and
other words and terms of similar meaning or use of future dates.
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties that could
negatively affect our business, operating results, financial
condition and stock price. Factors that could cause actual results
to differ materially from those currently anticipated are: risks to
an approval of Mino-Lok by the FDA; our ability to commercialize
our products, including Mino-Lok, if approved by the FDA; risks
relating to the results of research and development activities,
including those from existing and new pipeline assets;
uncertainties relating to preclinical and clinical testing; the
early stage of products under development; our need for substantial
additional funds; our dependence on third-party suppliers; our
ability to procure cGMP commercial-scale supply; the estimated
markets for our product candidates and the acceptance thereof by
any market; the ability of our product candidates to impact the
quality of life of our target patient populations; our ability to
obtain, perform under and maintain financing and strategic
agreements and relationships; market and other conditions; our
ability to attract, integrate, and retain key personnel; risks
related to our growth strategy; patent and intellectual property
matters; our ability to identify, acquire, close and integrate
product candidates and companies successfully and on a timely
basis; government regulation; competition; as well as other risks
described in our SEC filings. These risks have been and may be
further impacted by Covid-19 and could be impacted by any future
public health risks. Accordingly, these forward-looking statements
do not constitute guarantees of future performance, and you are
cautioned not to place undue reliance on these forward-looking
statements. Risks regarding our business are described in detail in
our SEC filings which are available on the SEC's website at
www.sec.gov, including in our Annual Report on Form 10-K for the
year ended September 30, 2023, filed
with the SEC on December 29, 2023,
and updated by our subsequent filings with the SEC. These
forward-looking statements speak only as of the date hereof, and we
expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Pharmaceuticals, Inc.