Citius Pharma Hits Primary and Secondary Endpoints in Mino-Lok Phase 3 Trial

Citius Pharmaceuticals, Inc., a biopharmaceutical company focusing on critical care products, has announced positive results from its pivotal Phase 3 clinical trial for Mino-Lok, an innovative antibiotic lock solution intended to salvage catheters in patients with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The trial met its primary endpoint, demonstrating a statistically significant delay in the time to catheter failure in patients treated with Mino-Lok compared to those receiving the standard clinician-directed anti-infective lock solution. Additionally, the secondary endpoint showed a significantly higher success rate in patients retaining their catheters when treated with Mino-Lok.

The Phase 3 trial, designated MDA 2013-0039 (NCT02901717), was a multicenter, randomized, open-label study conducted in the United States and India. It aimed to assess the safety and efficacy of Mino-Lok as an adjunctive therapy to systemic anti-infectives for treating CRBSI and CLABSI. A total of 241 patients with an indwelling central venous catheter were randomized in a 1:1 ratio to either receive Mino-Lok or the standard of care (SOC) site-specific anti-infective lock solution along with SOC systemic antibiotics.

Patients in the Mino-Lok arm received a daily dose of the solution with a dwell time of two to four hours over a period of up to 15 days. The primary endpoint was defined as the time to a catheter failure event, measured in days from randomization to the test of cure (TOC) at six weeks. Secondary outcome measures included overall success, microbiological eradication, and clinical cure.

The trial results were compelling. Patients treated with Mino-Lok experienced a significantly later occurrence of catheter failure events compared to the control group, with a p-value of 0.0006. The median time-to-failure (MTF) for the control arm was 33 days, whereas the MTF for the Mino-Lok arm exceeded the trial duration and was therefore not estimable. Additionally, 57.1% of Mino-Lok patients achieved overall treatment success at six weeks, compared to 37.7% in the control group, with a p-value of 0.0025.

Mino-Lok was well-tolerated, with no serious adverse events attributed to the drug. Serious adverse events occurred in 45.1% of the Mino-Lok arm and 46.1% of the control arm, indicating comparable safety profiles between the two groups.

Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed satisfaction with the trial results, emphasizing Mino-Lok's potential to become a new standard of care for patients with bloodstream infections. Mazur highlighted the therapy's non-invasive nature, offering a preferable alternative to the current practice of catheter removal and replacement.

Citius Pharmaceuticals plans to engage with the US Food and Drug Administration (FDA) to discuss the optimal path forward for Mino-Lok. The company remains committed to improving patient outcomes and providing an essential alternative to existing treatments for central venous catheter-related infections.

Overall, the successful Phase 3 trial underscores Mino-Lok's efficacy and safety in treating serious catheter-related bloodstream infections, potentially revolutionizing standard treatment protocols and reducing the need for invasive catheter removal and replacement procedures.