CRANFORD, N.J. - Citius Pharmaceuticals, Inc. (NASDAQ: NASDAQ:CTXR), a biopharmaceutical company, today announced that its Phase 3 trial of Mino-Lok, an antibiotic lock solution, met its primary endpoint and demonstrated overall treatment success. The trial aimed to evaluate the efficacy of Mino-Lok in salvaging catheters in patients with central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI).
The study, which included 241 patients from the U.S. and India, compared Mino-Lok therapy to a control group receiving standard of care (SOC) anti-infective lock solutions. The primary endpoint was the time to a catheter failure event, which occurred significantly later for patients treated with Mino-Lok (p=0.0006). Additionally, the secondary endpoint showed a higher overall treatment success rate in the Mino-Lok arm at 57.1% compared to 37.7% in the control arm (p=0.0025).
Safety data indicated that Mino-Lok was well-tolerated, with no serious adverse events related to the drug. Serious adverse events occurred at similar rates in both the Mino-Lok and control arms.
Leonard Mazur, Chairman and CEO of Citius, expressed satisfaction with the trial results, noting the potential for Mino-Lok to set a new standard of care as an adjunct therapy in treating patients with bloodstream infections. The company plans to engage with the FDA to discuss the next steps for Mino-Lok.
Mino-Lok, which combines minocycline, ethanol, and edetate disodium, is designed to offer an alternative to removing and replacing central venous catheters, potentially reducing adverse events and healthcare costs. If approved, it would be the first FDA-approved treatment for salvaging central venous catheters causing bloodstream infections.
The trial results are based on a press release statement from Citius Pharmaceuticals.
InvestingPro Insights
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) has recently made headlines with its Phase 3 trial success for Mino-Lok, but what does the financial picture reveal for potential investors? According to InvestingPro data, Citius has a market capitalization of approximately $119.21 million, underscoring its position as a small-cap biopharmaceutical company. The data also highlights a P/E ratio of -2.76, reflecting investor sentiment about future growth prospects in light of recent clinical advancements.
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