Citius Pharmaceuticals to Accelerate Phase 3 Mino-Lok Trial by Expanding Trial Sites Internationally

Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, announced that it has selected Biorasi, LLC (“Biorasi”), a global clinical research organization (CRO), to help expand the Company’s Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related blood stream infections (CRBSIs).

“Citius is pleased to collaborate with Biorasi to expand the Mino-Lok trial to include international clinical sites, as originally planned. This complements efforts underway in the U.S. by our lead CRO, Medpace, to drive recruitment. We paused our ex-U.S. strategy as COVID-19 spread across the globe and hospitals halted non-COVID trials. With the COVID-19 pandemic receding, we believe there is now an opportunity to access additional sites and plan to leverage Biorasi’s track record of quickly ramping up sites around the world to recruit clinical trial subjects outside the U.S. CRBSIs remain a critical unmet need globally with millions of patients requiring sterile central venous catheters to receive life-saving therapies,” stated Leonard Mazur, Chairman and CEO of Citius.

“We are committed to continuing to recruit patients until we reach the minimum required trial events, as per FDA guidance and outlined in our trial protocol to achieve statistically significant results. This will enable us to optimize the potential of a successful New Drug Application (NDA) submission. We believe our efforts to establish trial sites outside the U.S., combined with our ongoing initiatives, which have driven a recent increase in study enrollment at our U.S. sites, will assist us in reaching the necessary events to complete the trial by the end of this year,” added Mazur.