Citius Pharmaceuticals Announces Positive Phase 3 Trial Topline Results
DENVER, Colo., May 21, 2024 (247marketnews.com)- Citius Pharmaceuticals, Inc. (Nasdaq:CTXR) achieved primary and secondary endpoints in its Phase 3 Trial of Mino-Lok Antibiotic Lock Solution, 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.
Leonard Mazur, Chairman and Chief Executive Officer of Citius, commented, “We are extremely pleased by the strong results of the trial, which demonstrate the safety and efficacy of Mino-Lok in preserving indwelling catheters in patients with bloodstream infections. The data indicate, with a high degree of statistical significance, that Mino-Lok outperforms anti-infective lock solutions utilized in patients with CLABSI or CRBSI in the study’s control arm. We believe Mino-Lok could potentially set a new standard of care (SOC) as an adjunct therapy in the treatment of patients with bloodstream infections. This therapy offers a non-invasive treatment option compared to catheter removal and replacement.
“We look forward to engaging with the US Food and Drug Administration (FDA) to determine the optimal path forward for Mino-Lok. Our focus remains on improving outcomes for patients and offering a much-needed alternative to the current practice of catheter removal and replacement.”
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