Citius reaches 92 milestone events in phase 3 catheter-related bloodstream infections trial

The company says it is dedicated to the development and commercialization of critical care products and made the announcement on Thursday last week (August 10).

The important milestone in the clinical trial for Mino-Lok is now waiting for confirmation from an adjudication committee of independent reviewers to agree the 92 events to complete the trial have been achieved and Citius believes they have.

"This is a significant milestone for Citius as we approach completion of the Phase 3 Mino-Lok trial. As we complete therapy for patients in active treatment, we will continue to enroll patients in the pipeline and initiate shutdown activities," said Leonard Mazur, chairman and chief executive officer of Citius.

The Mino-Lok phase 3 pivotal superiority trial​ 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. Citius says 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) and central line–associated bloodstream infection (CLABSI) and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok therapy or standard of care 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 a product 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 focuses on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The company's pipeline includes two late-stage product candidates including Mino-Lok and Lymphir (E7777), a novel IL-2R immunotherapy. Mino-Lok was granted fast track designation by the FDA. Lymphir received orphan drug designation by the FDA for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). At the end of March 2023, Citius completed enrollment in its phase 2b trial of CITI-002, a topical formulation for the relief of hemorrhoids​.