Bloodstream Infection Treatment: Phase 3 Trial of Mino-Lok Completed

Citius Pharmaceuticals completes Phase 3 trial enrollment for Mino-Lok, a novel antibiotic lock solution aimed at salvaging catheters in patients with CRBSI. This non-invasive solution could revolutionize care for cancer and hemodialysis patients, offering a cost-effective alternative to current catheter treatments.

Citius Pharmaceuticals has announced achieving a pivotal milestone with the completion of patient enrollment for the Phase 3 clinical trial of Mino-Lok®, an innovative antibiotic lock solution targeting catheter-related bloodstream infections (CRBSI). This marks a critical advancement in the healthcare sector, potentially revolutionizing the treatment of catheter-related bloodstream infections. If approved, Mino-Lok® will be the first FDA-approved therapy for salvaging central venous catheters in bloodstream infections.

The event-based trial, enrolling 241 patients across clinical sites in the U.S. and India, witnessed 109 catheter failure events, surpassing the minimum requirement of 92 failures needed to conclude the trial successfully. The trial's primary objective was to evaluate the time to a catheter failure event between randomization and Week 6 in the intent-to-treat (ITT) population.

Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed the company's enthusiasm at achieving this critical milestone: "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 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."

The Mino-Lok Phase 3 Protocol

The Mino-Lok Phase 3 trial is designed as a multi-center, randomized, open-label, blinded study to assess the safety and efficacy of Mino-Lok, a combination of minocycline and edetate disodium. The trial's primary endpoint focuses on the time to a catheter failure event, with secondary measures including overall success, microbiological eradication, clinical cure, and others.

Patients enrolled in the trial are randomized to receive either Mino-Lok therapy or locally utilized antibiotic lock therapy in a 1:1 ratio. The protocol involves daily administration of Mino-Lok for a specified dwell time, whereas the control arm is determined based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines. Topline data from the trial are expected to be released in the second quarter of 2024.

Mino-Lok, licensed from The University of Texas MD Anderson Cancer Center, is positioned by Citius Pharmaceuticals as a potential game-changer in the treatment of CRBSI. If approved, Mino-Lok could revolutionize the landscape as the first FDA-approved therapy dedicated to salvaging central venous catheters responsible for central line-related bloodstream infections, potentially reducing adverse events and healthcare costs.

About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.