Tuesday, Citius Pharmaceuticals Inc. (NASDAQ:CTXR) announced the topline results of its Phase 3 trial of Mino-Lok, an antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI).
The study met its primary endpoint with a statistically significant improvement in the time to failure event in patients receiving Mino-Lok compared to Control arm patients receiving clinician-directed anti-infective lock solution.
Catheter failure was defined as the inability to administer study lock solution, catheter removal for any infection-related reason (including worsening clinical signs and symptoms or persistence or recurrence of baseline pathogen, or new infection), and all-cause mortality.
Time to catheter failure events in patients receiving Mino-Lok therapy occurred substantially later than in patients in the Control arm (p-value = 0.0006).
- Median time-to-failure (MTF) of the Control arm: 33 days.
- MTF of Mino-Lok arm: MTF exceeded the time the patients were on trial and, therefore, not estimable.
The hazard ratio of this study was 0.53.
The critical secondary endpoints included the proportion of patients at six weeks with overall treatment success, including no catheter failure, clinical cure (absence of baseline clinical signs and symptoms of infection or improvement of clinical signs and symptoms such that no additional therapy was necessary), or microbiological eradication (absence of the baseline pathogen).
Results in all randomized patients who received at least one dose of study lock solution demonstrate overall treatment success in 57.1% of patients in the Mino-Lok arm and 37.7% of patients in the Control arm (p=0.0025).
The data demonstrate that Mino-Lok is well-tolerated. No serious adverse events were drug-related.
Serious adverse events occurred in 45.1% of patients in the Mino-Lok arm and 46.1% in the Control arm.
Price Action: CTXR shares are up 12.20% at $0.74 at last check Tuesday.