Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok® Therapeutic to Salvage Catheters
- Completion of pivotal Phase 3 trial is a crucial milestone
- Positive data from prior Phase 2 study and interim reviews by an Independent Data Monitoring Committee
- Potential to provide a non-invasive and cost-effective alternative to the current practice of catheter removal and replacement
- 109 catheter failures observed
- Potential delays in analyzing trial data
- Uncertainty around approval of Mino-Lok as the only therapy to salvage catheters
Insights
The completion of enrollment in Citius Pharmaceuticals' Phase 3 clinical trial marks a significant step in the development of Mino-Lok, potentially impacting the treatment landscape for patients with CRBSI. The observation of 109 catheter failure events surpasses the minimum threshold needed for the trial's completion, indicating a robust sample size that could enhance the statistical power and reliability of the trial outcomes.
The trial's design, focusing on the efficacy and safety of Mino-Lok as an antibiotic lock therapy, is poised to offer a non-invasive alternative to the current invasive procedure of catheter removal and replacement. This could result in reduced hospital stays, lower medical costs and improved patient outcomes. Furthermore, the trial's international scope, with sites in the U.S. and India, may facilitate a diverse patient population, potentially broadening the applicability of the trial's findings.
Should Mino-Lok receive FDA approval, it would become the first therapy of its kind in the market. This exclusivity could translate into a competitive advantage for Citius Pharmaceuticals, potentially leading to significant market share in the CRBSI treatment sector. The anticipation of topline data in the second quarter of 2024 will be a critical inflection point for the company's stock valuation.
The economic implications of introducing Mino-Lok as a first-and-only antibiotic lock solution are multifaceted. From a healthcare economics perspective, the adoption of Mino-Lok could lead to cost savings by averting the need for catheter removal surgeries, which are not only invasive but also resource-intensive. By potentially reducing the incidence of complications associated with CRBSI, Mino-Lok could decrease the overall healthcare burden.
Moreover, the economic impact extends beyond direct healthcare savings. The reduction in catheter-related complications could lead to shorter hospital stays and a decrease in the indirect costs associated with patient morbidity, such as loss of productivity. As healthcare systems globally move towards value-based care models, solutions like Mino-Lok that promise both clinical efficacy and cost-effectiveness are likely to be favorably received.
However, the long-term economic impact will depend on factors such as pricing strategy, market penetration and reimbursement policies. The company's ability to navigate these factors successfully will be crucial in determining the overall financial viability and market success of Mino-Lok.
As Citius Pharmaceuticals approaches the release of topline data for Mino-Lok, market analysts will closely monitor the company's progress. The successful completion of the Phase 3 trial could signify a substantial market opportunity, given the lack of alternative therapies for CRBSI. The trial's positive outcome could catalyze the company's growth trajectory and attract investor attention.
It is essential to consider the competitive landscape and potential market size for Mino-Lok. CRBSI is a significant healthcare problem with a considerable patient population requiring treatment, thus representing a lucrative market. However, the market dynamics will also be influenced by the rate of adoption among healthcare providers, the therapy's integration into existing treatment protocols and potential competition from other pharmaceutical companies developing alternative treatments.
Analysts will also evaluate the strategic partnerships and distribution channels that Citius may establish to maximize the commercial potential of Mino-Lok, especially in markets outside the U.S. and India. The company's stock performance leading up to and following the release of topline data will likely reflect investor sentiment regarding these factors.
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
"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
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.
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