Pharmaceutical Company Achieves Milestone Promising Topline Results
Citius Pharmaceuticals Achieves Key Milestones in Phase 3 Trial of Mino-Lok Antibiotic Lock Solution.
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Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a late-stage biopharmaceutical company specializing in the development and commercialization of first-in-class critical care products, has announced promising topline results from its pivotal Phase 3 clinical trial of Mino-Lok®, a novel antibiotic lock solution. Designed to salvage catheters in patients afflicted with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI), Mino-Lok demonstrated significant efficacy and safety in achieving primary and secondary endpoints.
The Clinical Challenge of CLABSI and CRBSI
Infections associated with central venous catheters present a substantial challenge in healthcare settings, leading to increased morbidity, extended hospital stays, and heightened medical costs. Traditional management often involves removing and replacing infected catheters, a procedure that poses its own risks and inconveniences to patients. Citius Pharmaceuticals aims to revolutionize this treatment paradigm with Mino-Lok, offering a non-invasive alternative that maintains catheter function while effectively combating infections.
The Phase 3 trial, identified as MDA 2013-0039 (NCT02901717), was a multicenter, randomized, open-label, active-controlled, assessor-blinded study conducted across sites in the U.S. and India. This trial enrolled a total of 241 patients with indwelling central venous catheters who developed bloodstream infections. Patients were randomized in a 1:1 ratio to receive either Mino-Lok or a standard-of-care (SOC) anti-infective lock solution in conjunction with systemic antibiotics.
Patients in the Mino-Lok arm received one daily dose with a dwell time of two to four hours, administered over a period of up to 15 days. In contrast, the control arm involved clinician-determined antibiotic locks based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines. The primary endpoint of the study was the time to catheter failure event between randomization and the test of cure (TOC) at six weeks, measured in days. Catheter failure was defined by several criteria, including the inability to administer the study lock solution, catheter removal due to infection-related reasons, persistent or recurrent baseline pathogen, new infections, and all-cause mortality. Secondary endpoints encompassed overall success rates, microbiological eradication, and clinical cure among other measures. These metrics provided a comprehensive assessment of the efficacy and safety of Mino-Lok compared to existing SOC therapies. The results of the Phase 3 trial underscore the potential of Mino-Lok to set a new standard of care in the treatment of catheter-related bloodstream infections. Mino-Lok achieved a statistically significant improvement in the primary endpoint of time to catheter failure event compared to the control arm. Patients receiving Mino-Lok experienced longer periods without catheter failure, indicating superior efficacy over the clinician-directed anti-infective lock solutions used in the control group.
Mino-Lok was well-tolerated among patients, demonstrating a favorable safety profile. The absence of serious adverse effects related to Mino-Lok highlights its potential as a viable therapeutic option for managing CLABSI and CRBSI without necessitating catheter removal and replacement.
Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals, expressed his satisfaction with the trial outcomes, stating, “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.” Mazur also highlighted the next steps for Mino-Lok's development, adding, "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." The successful completion of the Phase 3 trial marks a significant milestone for Citius Pharmaceuticals and the future of infectious disease management. Mino-Lok not only offers a less invasive alternative to catheter removal but also promises to reduce the risk of complications associated with catheter replacement procedures. This can lead to improved patient outcomes, reduced healthcare costs, and greater overall efficiency in managing catheter-related bloodstream infections.
Tentative Path Forward
As Citius Pharmaceuticals prepares to engage with the FDA, the company aims to secure regulatory approval for Mino-Lok and facilitate its entry into the market. The positive trial results bolster the case for Mino-Lok as a transformative therapy, paving the way for its adoption in clinical settings where effective and safe management of CLABSI and CRBSI is critical. The engagement with the FDA will involve detailed discussions on the trial results, safety data, and potential labeling considerations. Citius Pharmaceuticals is committed to working closely with regulatory authorities to ensure that Mino-Lok meets all necessary standards and requirements for approval.
Citius Pharmaceuticals' Phase 3 trial results for Mino-Lok represent a breakthrough in the treatment of catheter-related bloodstream infections. With its demonstrated efficacy and safety, Mino-Lok holds the potential to revolutionize current treatment practices, offering a non-invasive and effective solution for a significant clinical challenge. As the company advances towards regulatory approval, patients and healthcare providers alike can anticipate a new era in the management of CLABSI and CRBSI, driven by innovative therapies like Mino-Lok. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to developing and commercializing first-in-class critical care products, has announced positive topline results from its pivotal Phase 3 clinical trial of Mino-Lok®. This novel antibiotic lock solution is designed to salvage catheters in patients afflicted with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The study met its primary endpoint, demonstrating a statistically significant improvement in the time to catheter failure event in patients receiving Mino-Lok compared to those receiving a clinician-directed anti-infective lock solution in the control arm.
The Phase 3 trial, designated as MDA 2013-0039 (NCT02901717), was a multicenter, randomized, open-label, active-controlled, assessor-blinded study conducted across sites in the U.S. and India. It enrolled a total of 241 patients with indwelling central venous catheters who developed bloodstream infections. These patients were randomized in a 1:1 ratio to receive either Mino-Lok or a standard-of-care (SOC) anti-infective lock solution along with SOC systemic antibiotics.
Patients in the Mino-Lok arm received one dose daily with a dwell time of two to four hours over a period of up to 15 days. In contrast, the control arm involved clinician-determined antibiotic locks based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.
Primary Endpoint Results
The primary endpoint of the study was the time to a catheter failure event between randomization and the test of cure (TOC) at six weeks, measured in days. Catheter failure was defined by several criteria, including the inability to administer the study lock solution, catheter removal for any infection-related reason, persistent or recurrent baseline pathogen, new infections, and all-cause mortality. Results showed that time to catheter failure events in patients receiving Mino-Lok therapy occurred substantially later than in patients in the Control arm. The p value for this comparison was 0.0006, indicating high statistical significance.
Median Time-to-Failure (MTF) in Control Arm: 33 days (95% CI: 14 days – 44 days; n = 122)
Median Time-to-Failure (MTF) in Mino-Lok Arm: Not estimable (NE) because MTF exceeded the time patients were on trial (95% CI: 50 days - NE; n = 119)
Hazard Ratio: 0.53
These findings indicate that Mino-Lok significantly prolonged the time to catheter failure compared to the control treatment, marking a substantial advancement in the management of CLABSI and CRBSI. Critical secondary endpoints included the proportion of patients at six weeks with overall treatment success, defined by no catheter failure, clinical cure (absence of baseline clinical signs and symptoms of infection or improvement such that no additional therapy was necessary), or microbiological eradication (absence of the baseline pathogen). Results demonstrated overall treatment success in:
57.1% of patients in the Mino-Lok arm
37.7% of patients in the Control arm
The difference in overall treatment success was statistically significant, with a p value of 0.0025.
Safety Profile
Mino-Lok is designed for intracatheter instillation and is not intended for intravenous injection or systemic circulation. The safety profile of Mino-Lok was comparable to the control treatment, with no serious adverse events attributed to the drug.
Serious Adverse Events:
Mino-Lok Arm: 45.1% of patients experienced serious adverse events.
Control Arm: 46.1% of patients experienced serious adverse events.
These findings suggest that Mino-Lok is well-tolerated and does not introduce additional safety risks compared to current SOC treatments. Mino-Lok (MLT) is an innovative antibiotic lock solution combining minocycline, ethanol, and edetate disodium. It is designed to treat patients with catheter-related bloodstream infections by eradicating pathogens while preserving the functionality of the central venous catheter (CVC). Citius Pharmaceuticals licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok offers a non-invasive alternative to the traditional approach of removing and replacing infected catheters. This method is not only less disruptive for patients but also potentially reduces the risk of complications and healthcare costs associated with catheter replacement procedures. The Phase 3 trial results underscore the potential of Mino-Lok to revolutionize the treatment of catheter-related bloodstream infections. By significantly extending the time to catheter failure and achieving higher rates of overall treatment success without introducing additional safety risks, Mino-Lok promises to set a new standard of care for managing CLABSI and CRBSI. Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharmaceuticals, expressed optimism about the future of Mino-Lok, stating, “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.”
Mazur further emphasized the company's commitment to advancing Mino-Lok toward regulatory approval, adding, "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."
Next Steps
Citius Pharmaceuticals intends to engage in detailed discussions with the FDA to secure regulatory approval for Mino-Lok. The positive Phase 3 trial results provide a robust foundation for these discussions, supporting the case for Mino-Lok as a first-in-class treatment that could transform clinical practices in managing catheter-related bloodstream infections.
With continued research and development, Mino-Lok could soon become an essential tool in the fight against these challenging infections, offering a safer, more effective, and less invasive treatment option for patients worldwide.
Disclaimer: The information provided in this article is based on data released by Citius Pharmaceuticals. Readers are advised to consult healthcare professionals for personalized medical advice and treatment options. The results discussed are subject to further validation and regulatory review.