Citius Pharma completes enrollment in pivotal phase 3 trial of Mino-Lok therapeutic to salvage catheters

Citius Pharmaceuticals, Inc., a late-stage biopharmaceutical company, 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.

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 US 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.

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.

Citius Pharma is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products.

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