Citius Pharmaceuticals, Inc. 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.

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. 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.