Cidara Therapeutics initiates ReStore Phase III study of rezafungin to treat candidiasis..

Cidara Therapeutics, Inc. announced that the first trial site has been activated for ReSTORE, a Phase III clinical trial evaluating the efficacy and safety of the company�s lead antifungal, rezafungin, to treat candidemia and invasive candidiasis. Rezafungin is a novel echinocandin antifungal being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections.

ReSTORE study is a global, randomized, double-blind, controlled Phase III pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. The trial design will be similar to the company�s Phase II STRIVE study, which met its primary safety and efficacy objectives. The ReSTORE trial is designed to evaluate one rezafungin dosing regimen of 400 milligrams (mg) for the first week followed by 200 mg of rezafungin once weekly for up to four weeks in total. This treatment arm will be compared to caspofungin in a 1:1 randomization. The primary efficacy endpoint of ReSTORE, which will be used for a FDA New Drug Application submission, is all-cause mortality at day 30. The primary efficacy endpoint for the European Medicines Agency (EMA) is expected to be global response at day 14.