Topline results expected 2Q 2024
Study enrolled a total of 241 patients; 109
catheter failures observed
First-and-only antibiotic lock solution in
development to salvage catheters in patients with CRBSI
CRANFORD, N.J., Jan. 2, 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 that it has completed enrollment in its pivotal
Phase 3 clinical trial for Mino-Lok®, an antibiotic lock
solution to salvage catheters in patients with catheter-related
bloodstream infections. A total of 109 catheter failure events were
observed in the event-based trial; a minimum of 92 catheter failure
events were required to complete the trial. The study enrolled 241
patients at clinical sites in the U.S. and India.
"Completing enrollment in our pivotal Phase 3 trial is a crucial
milestone in the development of Mino-Lok, bringing us closer to
addressing the limitations of the current standard of care for
patients with catheter related blood stream infections (CRBSI). It
is a testament to the dedication and hard work of our entire team.
We extend our deepest appreciation to the patients, investigators,
and healthcare professionals who have been integral to the
successful enrollment of this trial," stated Leonard Mazur, Chairman and Chief Executive
Officer of Citius.
"We now plan to focus on analyzing the data from the trial and
expect to have topline data available in the second quarter of 2024
This trial builds on the positive data from a prior Phase 2 study
of the safety and efficacy of Mino-lok, and three interim reviews
by an Independent Data Monitoring Committee that recommended
continuation of the trial following each review. If approved,
Mino-Lok would be the only therapy to salvage catheters, providing
a non-invasive and cost-effective alternative to the current
practice of removal and replacement of the infected catheter,"
added Mazur.
Mino-Lok Phase 3 Trial Design
The Mino-Lok Phase 3 pivotal superiority trial (NCT02901717) is
a multi-center, randomized, open-label, blinded study to determine
the efficacy and safety of Mino-Lok (MLT), a novel antibiotic
lock therapy that combines minocycline with edetate disodium. The
trial is being conducted in the U.S. and India. The primary endpoint for this study is
the time (in days following randomization) to a catheter failure
event between randomization and TOC (Week 6) in the
Intent-to-Treat (ITT) Population. Additional secondary outcome
measures include overall success, microbiological eradication, and
clinical cure, among others.
Patients diagnosed with catheter related blood stream infections
(CRBSI/CLABSI) and who meet all necessary criteria for the study
are randomized in a 1:1 ratio to receive either Mino-Lok therapy or
locally utilized antibiotic lock therapy.
Patients in the Mino-Lok arm receive one MLT dose daily with a
dwell time of two to four hours for a total of seven doses. For
subjects in the Control arm, the investigator determines 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.
About Mino-Lok
Mino-Lok is an antibiotic lock solution to treat patients with
catheter-related blood stream infections that Citius has licensed
from The University of Texas MD
Anderson Cancer Center. Citius believes Mino-Lok provides a
superior alternative to removing and replacing a central venous
catheter (CVC), leading 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 Pharma 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. At the end of
2023, Citius completed enrollment in a Phase 3 Pivotal superiority
trial of Mino-Lok®, an antibiotic lock solution to salvage
catheters in patients with catheter-related bloodstream infections.
Citius is preparing to resubmit the Biologics License Application
for LYMPHIR, a novel IL-2R immunotherapy for an initial indication
in cutaneous T-cell lymphoma, in early 2024, and 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 relating to the results of
research and development activities, including those from the
Mino-Lok Phase 3 trial and other existing and new pipeline assets;
our need for substantial additional funds; our ability to
commercialize our products if approved by the FDA; 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;
uncertainties relating to preclinical and clinical testing; the
early stage of products under development; 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 Securities and Exchange Commission
("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 Securities and
Exchange Commission. 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.