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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
May 21, 2024
Citius Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Nevada
(State or other jurisdiction of incorporation)
001-38174 |
|
27-3425913 |
(Commission File Number) |
|
(IRS Employer
Identification No.) |
11 Commerce Drive, 1st Floor, Cranford, NJ |
|
07016 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area
code (908) 967-6677
Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ | Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| | |
| ☐ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| | |
| ☐ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| | |
| ☐ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common stock, $0.001 par value |
|
CTXR |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On May 21, 2024, we issued a press release announcing
positive topline results of our pivotal Phase 3 clinical trial of Mino-Lok in patients with central line-associated infections or catheter-related
bloodstream infections. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
SIGNATURE
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
CITIUS PHARMACEUTICALS, INC. |
|
|
Date: May 21, 2024 |
/s/ Leonard Mazur |
|
Leonard Mazur |
|
Chairman and Chief Executive Officer |
Exhibit 99.1
Citius Pharmaceuticals Achieves Primary and
Secondary Endpoints in Phase 3 Trial of Mino-Lok Antibiotic Lock Solution
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 -- 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) |
| o | Median time-to-failure (MTF) of Control arm: 33 days; 95%
confidence interval (CI) (14 days – 44 days; n = 122) |
| o | 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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