Citius Completes Key Phase 3 Trial Enrollment for Mino-Lok® Catheter Salvage Therapy

Citius Pharmaceuticals, a biopharmaceutical firm focused on critical care products, has announced the completion of patient enrollment in a Phase 3 clinical trial for its Mino-Lok® antibiotic lock solution. This therapy aims to preserve catheters in patients suffering from catheter-related bloodstream infections (CRBSI). The event-driven study, which required a minimum of 92 catheter failures to conclude, observed 109 such incidents. It involved 241 participants across clinical sites in the United States and India.

Leonard Mazur, Citius's CEO and Chairman, emphasized the significance of this milestone, highlighting the commitment of the team and expressing gratitude to all involved in the trial's successful enrollment. He also mentioned that the company will now concentrate on data analysis, anticipating preliminary results in the second quarter of 2024. The Phase 3 trial builds upon positive findings from a Phase 2 study and subsequent reviews by an Independent Data Monitoring Committee.

The Mino-Lok Phase 3 trial is a multi-center, randomized, open-label, blinded study (NCT02901717) designed to evaluate the efficacy and safety of Mino-Lok, which combines minocycline with edetate disodium. The primary goal is to measure the time to catheter failure post-randomization up to six weeks in the Intent-to-Treat population. Secondary outcomes include overall success rate, microbiological eradication, and clinical cure.

Eligible patients diagnosed with CRBSI/CLABSI are randomly assigned to receive either Mino-Lok therapy or locally used antibiotic lock therapy. Mino-Lok recipients get one dose daily for seven days, with a dwell time of two to four hours. The control group's treatment is determined by institutional standards or Infectious Diseases Society of America guidelines.

Mino-Lok, licensed from The University of Texas MD Anderson Cancer Center, is seen as a superior alternative to the current practice of catheter removal and replacement. Approval would make Mino-Lok the first FDA-approved treatment for salvaging central venous catheters causing central line-related bloodstream infections.

Citius Pharmaceuticals is in the late stages of developing first-in-class critical care products, with a diverse pipeline featuring two late-stage candidates. The company is also preparing to resubmit the Biologics License Application for LYMPHIR, an IL-2R immunotherapy for cutaneous T-cell lymphoma, and has plans to establish Citius Oncology, a standalone company centered around LYMPHIR. Additionally, Citius has completed enrollment in a Phase 2b trial for CITI-002 (Halo-Lido), a hemorrhoid relief topical formulation.