Citius hires Biorasi to accelerate Mino-Lok study by adding sites outside the US

Citius Pharmaceuticals has hired Biorasi to expand trials of its antibiotic lock solution Mino-Lok to research sites outside the US.

The contract – financial terms of which were not disclosed – will see US-based Borasi run the Phase III study at unspecified “international” sites.

In the US, Medpace is running the program, which is assessing Mino-Lok – a combination of minocycline with edetate disodium- as a therapy for the treatment of catheter-related or central line associated bloodstream infection (CRBSI).

Citius CEO Leonard Mazur said the firm originally planned to include sites outside the US but was forced to delay the roll out due by the coronavirus pandemic.

“We paused our ex-US 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 US.

“CRBSIs remain a critical unmet need globally with millions of patients requiring sterile central venous catheters to receive life-saving therapies.”

Mazur also predicted that Biorasi will help the study reach its recruitment goals.

"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 US, combined with our ongoing initiatives, which have driven a recent increase in study enrolment at our US sites, will assist us in reaching the necessary events to complete the trial by the end of this year," added Mazur.

Biorasi is headquartered in Miami, Florida. Its operations in Europe are based at sites in Germany, Ukraine and Russia. It also has a base in Maharashtra, India.

The contract is the second Biorasi has announced this month. Last week, the firm revealed that California’s Therapeutic Solutions had asked it to run a trial of JadiCell, a stem cell based treatment being developed for COVID-19 associated lung failure.

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