Citius Pharmaceuticals has chosen international clinical research organisation (CRO) Biorasi to aid in expanding its Phase III Mino-Lok clinical trial of a new antibiotic lock therapy to additional sites outside the US.
The company had previously stopped the ex-US strategy with the onset of the Covid-19 pandemic.
Citius will use the track record of Biorasi to rapidly scale up sites globally to enrol trial participants outside the US.
Named Mino-Lok (MLT), the therapy merges minocycline and edetate disodium.
The multi-centre, randomised, open-label, blinded, superiority trial will analyse the safety and efficacy of the therapy.
Time to a catheter failure event between randomisation and test of cure (TOC) at week six in the intent-to-treat (ITT) population is the trial’s primary endpoint.
A microbiological eradication and clinical cure assessment will be included as other secondary endpoints in the trial.
In the trial, participants in the Mino-Lok arm will be given a once-a-day dose of MLT, with a dwell time of two to four hours, for seven doses.
Subjects in the control arm will be given the investigator-chosen antibiotic used in the lock, dose, dwell time, and number of days of dosing as per the institutional standards or guidelines of the Infectious Diseases Society of America (IDSA).
On obtaining approval from the Food and Drug Administration (FDA), Mino-Lok is claimed to become the first-and-only antibiotic lock solution to recover infected central venous catheters (CVCs) leading to catheter-related bloodstream infections (CRBSIs).
Citius Pharmaceuticals chairman and CEO Leonard Mazur said: “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 US by our lead CRO, Medpace, to drive recruitment.”
CRBSIs remain a crucial unmet need across the globe as millions of patients need sterile central venous catheters for receiving life-saving treatments.
In April this year, the company enrolled the first participant in a Phase IIb trial of its therapy, Halo-Lido, for treating haemorrhoids.