Cidara Therapeutics and Mundipharma have concluded subject enrolment in the pivotal Phase III ReSTORE clinical trial of antifungal drug, rezafungin, as first-line therapy for candidemia and invasive candidiasis.
Rezafungin is a new echinocandin being developed for the prevention and treatment of serious fungal infections.
The Phase III trial enrolled a total of 184 patients with candidemia and/or invasive candidiasis.
These subjects are categorised in a 1:1 ratio to receive either a once-weekly intravenous dose of rezafungin or once-daily dose standard of care (SoC) therapy, caspofungin.
The global, randomised, double-blind, controlled trial will assess the efficacy and safety of a dosing regimen where 400mg rezafungin is given for the first week and then 200mg once-weekly for up to a total of four weeks.
This non-inferiority trial is carried out at more than 100 study sites in 18 countries worldwide.
Cidara noted that the trial centres in China will continue subject enrolment to submit data of rezafungin required by the Centre of Drug Evaluation.
All-cause mortality at day 30 will be the trial’s primary efficacy goal to support a new drug application (NDA) to the US Food and Drug Administration.
Global response at day 14 is the primary efficacy goal for the European Medicines Agency.
The company expects top-line data from the trial later this year.
Cidara Therapeutics president and CEO Jeffrey Stein said: “If approved, rezafungin would be the first new therapy for the treatment of this deadly disease in over a decade.
“With the completion of enrolment of ReSTORE, we remain on track to announce top-line data by the end of this year and anticipate filing our new drug application in the US and similar regulatory filings outside the US in mid-2022.”
In September 2019, Cidara collaborated with Mundipharma in a deal valued at more than $568m to develop and commercialise rezafungin for regions outside the US and Japan.
Currently, a global Phase III ReSPECT trial is assessing rezafungin against the standard antimicrobial regimen for the prevention of invasive fungal disease caused by Candida, Aspergillus and Pneumocystis in allogeneic bone marrow transplant subjects.
The trial is progressing subject recruitment as planned.